Trial Outcomes & Findings for Study of Orofacial Pain and PropRANOlol (NCT NCT02437383)
NCT ID: NCT02437383
Last Updated: 2019-05-21
Results Overview
Weekly mean pain index computed as the arithmetic mean of daily pain index values during the week prior to randomization and prior to each study visit. Daily pain index is computed as pain intensity (0-100 numeric rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable") multiplied by pain duration (0-100 percentage scale where percent = "percent of waking day you had facial pain") as reported in the Daily Symptom Diary and divided by 100. The pain index range is from 0 to 100. A higher score means a worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
200 participants
Primary outcome timeframe
Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)
Results posted on
2019-05-21
Participant Flow
Participant milestones
| Measure |
Propranolol ER
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
87
|
87
|
|
Overall Study
NOT COMPLETED
|
13
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Orofacial Pain and PropRANOlol
Baseline characteristics by cohort
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.9 years
STANDARD_DEVIATION 12.19 • n=5 Participants
|
34.2 years
STANDARD_DEVIATION 13.29 • n=7 Participants
|
34.1 years
STANDARD_DEVIATION 12.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
93 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
79 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Weekly Mean Pain Intensity
|
47.9 units on a scale
STANDARD_DEVIATION 15.23 • n=5 Participants
|
47.4 units on a scale
STANDARD_DEVIATION 15.58 • n=7 Participants
|
47.6 units on a scale
STANDARD_DEVIATION 15.37 • n=5 Participants
|
|
Weekly Mean Pain Duration
|
56.6 units on a scale
STANDARD_DEVIATION 26.57 • n=5 Participants
|
60.1 units on a scale
STANDARD_DEVIATION 24.61 • n=7 Participants
|
58.3 units on a scale
STANDARD_DEVIATION 25.61 • n=5 Participants
|
|
Weekly Mean Pain Index
|
30.0 units on a scale
STANDARD_DEVIATION 19.96 • n=5 Participants
|
31.2 units on a scale
STANDARD_DEVIATION 18.94 • n=7 Participants
|
30.6 units on a scale
STANDARD_DEVIATION 19.42 • n=5 Participants
|
|
The SF-McGill Pain Questionnaire Affective Component
|
3.5 units on a scale
STANDARD_DEVIATION 2.22 • n=5 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 2.33 • n=7 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 2.27 • n=5 Participants
|
|
The SF-McGill Pain Questionnaire Sensory Component
|
5.1 units on a scale
STANDARD_DEVIATION 6.40 • n=5 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 6.12 • n=7 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 6.25 • n=5 Participants
|
|
The SF-McGill Pain Questionnaire Present Facial Pain Intensity
|
3.0 units on a scale
STANDARD_DEVIATION 0.87 • n=5 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 0.93 • n=7 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 0.90 • n=5 Participants
|
|
The SF-McGill Pain Questionnaire Weekly Average Facial Pain Intensity
|
56.0 units on a scale
STANDARD_DEVIATION 16.55 • n=5 Participants
|
56.2 units on a scale
STANDARD_DEVIATION 17.41 • n=7 Participants
|
56.1 units on a scale
STANDARD_DEVIATION 16.94 • n=5 Participants
|
|
The SF-McGill Pain Questionnaire Weekly Average Facial Pain Duration
|
63.2 units on a scale
STANDARD_DEVIATION 29.22 • n=5 Participants
|
67.0 units on a scale
STANDARD_DEVIATION 23.93 • n=7 Participants
|
65.1 units on a scale
STANDARD_DEVIATION 26.72 • n=5 Participants
|
|
The SF-McGill Pain Questionnaire Weekly Fatigue
|
41.8 units on a scale
STANDARD_DEVIATION 26.75 • n=5 Participants
|
41.1 units on a scale
STANDARD_DEVIATION 28.36 • n=7 Participants
|
41.4 units on a scale
STANDARD_DEVIATION 27.49 • n=5 Participants
|
|
Number of Participants Stratified per Graded Chronic Pain Scale (GCPS) grade
GCPS Grades 0-IIa
|
59 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Number of Participants Stratified per Graded Chronic Pain Scale (GCPS) grade
GCPS Grades IIb-IV
|
41 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
The Jaw Functional Limitation Scale (JFLS) Global Score
|
2.8 units on a scale
STANDARD_DEVIATION 1.76 • n=5 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 1.52 • n=7 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 1.64 • n=5 Participants
|
|
The Headache Impact Test (HIT-6) Global Score
|
54.4 units on a scale
STANDARD_DEVIATION 9.10 • n=5 Participants
|
55.2 units on a scale
STANDARD_DEVIATION 8.70 • n=7 Participants
|
54.8 units on a scale
STANDARD_DEVIATION 8.89 • n=5 Participants
|
|
The Perceived Stress Scale (PSS) Global Score
|
21.2 units on a scale
STANDARD_DEVIATION 8.99 • n=5 Participants
|
21.5 units on a scale
STANDARD_DEVIATION 9.12 • n=7 Participants
|
21.3 units on a scale
STANDARD_DEVIATION 9.03 • n=5 Participants
|
|
The Pittsburgh Sleep Quality Index (PSQI) Global Score
|
6.5 units on a scale
STANDARD_DEVIATION 3.66 • n=5 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 3.58 • n=7 Participants
|
6.5 units on a scale
STANDARD_DEVIATION 3.61 • n=5 Participants
|
|
The Hospital Anxiety and Depression Scale (HADS) Anxiety Score
|
6.9 units on a scale
STANDARD_DEVIATION 4.19 • n=5 Participants
|
7.5 units on a scale
STANDARD_DEVIATION 4.59 • n=7 Participants
|
7.2 units on a scale
STANDARD_DEVIATION 4.39 • n=5 Participants
|
|
The Hospital Anxiety and Depression Scale (HADS) Depression Score
|
3.7 units on a scale
STANDARD_DEVIATION 3.54 • n=5 Participants
|
3.3 units on a scale
STANDARD_DEVIATION 3.14 • n=7 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 3.35 • n=5 Participants
|
|
The Symptom Checklist 90-Revised (SCL-90R) Somatization Scale Score
|
0.6 units on a scale
STANDARD_DEVIATION 0.50 • n=5 Participants
|
0.7 units on a scale
STANDARD_DEVIATION 0.51 • n=7 Participants
|
0.6 units on a scale
STANDARD_DEVIATION 0.50 • n=5 Participants
|
|
The SF-12 Health Survey v2 (SF-12v2) Physical Component Summary (PCS)
|
48.4 units on a scale
STANDARD_DEVIATION 10.71 • n=5 Participants
|
50.0 units on a scale
STANDARD_DEVIATION 9.39 • n=7 Participants
|
49.2 units on a scale
STANDARD_DEVIATION 10.08 • n=5 Participants
|
|
The SF-12 Health Survey v2 (SF-12v2) Mental Component Summary (MCS)
|
49.0 units on a scale
STANDARD_DEVIATION 10.82 • n=5 Participants
|
48.9 units on a scale
STANDARD_DEVIATION 10.31 • n=7 Participants
|
48.9 units on a scale
STANDARD_DEVIATION 10.54 • n=5 Participants
|
|
Thermal Pain Threshold
|
41.3 degrees Celsius
STANDARD_DEVIATION 3.46 • n=5 Participants
|
41.4 degrees Celsius
STANDARD_DEVIATION 3.55 • n=7 Participants
|
41.3 degrees Celsius
STANDARD_DEVIATION 3.49 • n=5 Participants
|
|
Thermal Pain Tolerance
|
45.5 degrees Celsius
STANDARD_DEVIATION 3.17 • n=5 Participants
|
45.5 degrees Celsius
STANDARD_DEVIATION 3.22 • n=7 Participants
|
45.5 degrees Celsius
STANDARD_DEVIATION 3.19 • n=5 Participants
|
|
Pressure Pain Threshold at Temporalis Muscle
|
114 kPa
STANDARD_DEVIATION 62.0 • n=5 Participants
|
102 kPa
STANDARD_DEVIATION 52.9 • n=7 Participants
|
108 kPa
STANDARD_DEVIATION 57.8 • n=5 Participants
|
|
Pressure Pain Threshold at Masseter Muscle
|
106 kPa
STANDARD_DEVIATION 56.4 • n=5 Participants
|
95 kPa
STANDARD_DEVIATION 53.9 • n=7 Participants
|
101 kPa
STANDARD_DEVIATION 55.3 • n=5 Participants
|
|
Pressure Pain Threshold at Temporomandibular Joint
|
99 kPa
STANDARD_DEVIATION 53.4 • n=5 Participants
|
91 kPa
STANDARD_DEVIATION 51.8 • n=7 Participants
|
95 kPa
STANDARD_DEVIATION 52.6 • n=5 Participants
|
|
Pressure Pain Threshold at Trapezius Muscle
|
208 kPa
STANDARD_DEVIATION 108.0 • n=5 Participants
|
194 kPa
STANDARD_DEVIATION 114.2 • n=7 Participants
|
201 kPa
STANDARD_DEVIATION 111.1 • n=5 Participants
|
|
Pressure Pain Threshold at Lateral Epicondyle
|
213 kPa
STANDARD_DEVIATION 100.3 • n=5 Participants
|
213 kPa
STANDARD_DEVIATION 111.1 • n=7 Participants
|
213 kPa
STANDARD_DEVIATION 105.6 • n=5 Participants
|
|
Pain-free Jaw Opening
|
30.0 mm
STANDARD_DEVIATION 10.79 • n=5 Participants
|
29.6 mm
STANDARD_DEVIATION 11.58 • n=7 Participants
|
29.8 mm
STANDARD_DEVIATION 11.16 • n=5 Participants
|
|
Maximum Unassisted Jaw Opening
|
43.9 mm
STANDARD_DEVIATION 8.44 • n=5 Participants
|
44.5 mm
STANDARD_DEVIATION 10.08 • n=7 Participants
|
44.2 mm
STANDARD_DEVIATION 9.27 • n=5 Participants
|
|
Maximum Assisted Jaw Opening
|
47.6 mm
STANDARD_DEVIATION 8.92 • n=5 Participants
|
48.9 mm
STANDARD_DEVIATION 9.39 • n=7 Participants
|
48.2 mm
STANDARD_DEVIATION 9.16 • n=5 Participants
|
|
Systolic Blood Pressure
|
121.8 mm Hg
STANDARD_DEVIATION 12.65 • n=5 Participants
|
122.0 mm Hg
STANDARD_DEVIATION 15.19 • n=7 Participants
|
121.9 mm Hg
STANDARD_DEVIATION 13.93 • n=5 Participants
|
|
Diastolic Blood pressure
|
72.6 mm Hg
STANDARD_DEVIATION 9.73 • n=5 Participants
|
72.3 mm Hg
STANDARD_DEVIATION 10.84 • n=7 Participants
|
72.5 mm Hg
STANDARD_DEVIATION 10.27 • n=5 Participants
|
|
Heart Rate
|
74.0 beats per minute
STANDARD_DEVIATION 11.72 • n=5 Participants
|
73.3 beats per minute
STANDARD_DEVIATION 11.70 • n=7 Participants
|
73.7 beats per minute
STANDARD_DEVIATION 11.68 • n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
Weekly mean pain index computed as the arithmetic mean of daily pain index values during the week prior to randomization and prior to each study visit. Daily pain index is computed as pain intensity (0-100 numeric rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable") multiplied by pain duration (0-100 percentage scale where percent = "percent of waking day you had facial pain") as reported in the Daily Symptom Diary and divided by 100. The pain index range is from 0 to 100. A higher score means a worse outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in the Weekly Mean Pain Index After 9 Weeks of Treatment
|
-13.9 units on a scale
Interval -17.4 to -10.5
|
-12.1 units on a scale
Interval -15.5 to -8.7
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
Weekly mean pain intensity computed as the arithmetic mean of daily pain intensity values during the week prior to randomization and prior to each study visit. Daily pain intensity is measured on 0-100 numeric rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable") as reported in the Daily Symptom Diary. A higher score means a worse outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in the Weekly Mean Pain Intensity After 9 Weeks of Treatment
|
-17.1 units on a scale
Interval -21.1 to -13.1
|
-13.6 units on a scale
Interval -17.6 to -9.7
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Weekly mean pain duration computed as the arithmetic mean of daily pain duration values during the week prior to randomization and prior to each study visit. Daily pain duration is measured on 0-100 percentage scale where percent = "percent of waking day you had facial pain" as reported in the Daily Symptom Diary. A higher score means a worse outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in the Weekly Mean Pain Duration After 9 Weeks of Treatment
|
-17.9 units on a scale
Interval -22.8 to -13.0
|
-16.6 units on a scale
Interval -21.3 to -11.7
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
The SF-McGill Pain Questionnaire contains 4 affective descriptors rated on a 0-3 scale where 0 = "none," 1 = "mild," 2 = "moderate," and 3 = "severe." The item scores are summed to yield a total score ranging from 0 to 12. A higher score means a worse outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in the SF-McGill Pain Questionnaire Affective Component After 9 Weeks of Treatment
|
-2.9 score on a scale
Interval -3.7 to -2.0
|
-3.1 score on a scale
Interval -3.9 to -2.2
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
The SF-McGill Pain Questionnaire contains 11 sensory descriptors rated on a 0-3 scale where 0 = "none," 1 = "mild," 2 = "moderate," and 3 = "severe." The item scores are summed to yield a total score ranging from 0 to 33. A higher score means a worse outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in the SF-McGill Pain Questionnaire Sensory Component After 9 Weeks of Treatment
|
-1.9 score on a scale
Interval -2.2 to -1.6
|
-1.6 score on a scale
Interval -1.9 to -1.2
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
Self-reported present intensity of facial pain at the moment of assessment scored on a descriptive scale where 1 = "no pain' and 6 = "excruciating pain." A higher score means worse outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in the SF-McGill Pain Questionnaire Present Facial Pain Intensity After 9 Weeks of Treatment
|
-0.9 units on a scale
Interval -1.1 to -0.7
|
-0.7 units on a scale
Interval -0.9 to -0.5
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
Self-reported average facial pain intensity for the last week scored on 0-100 numerical rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable". A higher score means a worse outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in the SF-McGill Pain Questionnaire Weekly Average Facial Pain Intensity After 9 Weeks of Treatment
|
-18.2 units on a scale
Interval -22.6 to -13.8
|
-15.8 units on a scale
Interval -20.1 to -11.5
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
Self-reported average facial pain duration for the last week scored on 0-100 percentage scale where percent = "percent of waking day you had facial pain". A higher score means a worse outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in the SF-McGill Pain Questionnaire Weekly Average Facial Pain Duration After 9 Weeks of Treatment
|
-23.6 units on a scale
Interval -29.5 to -17.8
|
-21.6 units on a scale
Interval -27.3 to -16.0
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
Self-reported average fatigue for the last week scored on 0-100 numerical rating scale where 0 = "no fatigue" and 100 = "the greatest imaginable." A higher score means a worse outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in the SF-McGill Pain Questionnaire Weekly Fatigue After 9 Weeks of Treatment
|
-12.0 units on a scale
Interval -17.7 to -6.3
|
-11.4 units on a scale
Interval -16.9 to -5.8
|
SECONDARY outcome
Timeframe: Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
Individuals were classified into 6 chronic pain grades: 0 = no pain; I = low pain intensity and low pain-related disability; IIa = high pain intensity and low pain-related disability; IIb = high pain intensity and high activity interference; III = moderate pain-related disability; and IV = severe pain-related disability. For analyses, this variable was dichotomized: grades 0-IIa were combined in one category and all higher grades in another. A higher grade means a worse outcome.
Outcome measures
| Measure |
Propranolol ER
n=87 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=87 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Number of Participants Stratified Per Graded Chronic Pain Scale (GCPS) Grade After 9 Weeks of Treatment
GCPS Grades 0-IIa
|
75 Participants
|
69 Participants
|
|
Number of Participants Stratified Per Graded Chronic Pain Scale (GCPS) Grade After 9 Weeks of Treatment
GCPS Grades IIb-IV
|
12 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
The JFLS contains 20 items that measure limitations across mastication, vertical jaw mobility, and verbal/emotional expression rated on a 0-10 scale where 0 = "no limitation" and 10 = "severe limitation." The Global Score is computed as the mean response for all items and ranges from 0 to 10. A higher score means a worse outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in the Jaw Functional Limitation Scale (JFLS) Global Score After 9 Weeks of Treatment
|
-1.1 score on a scale
Interval -1.4 to -0.8
|
-0.8 score on a scale
Interval -1.1 to -0.6
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
The HIT-6 contains 6 items and assesses headache-related disability by the frequency of daily activity limitations ranging from "never" to "always." The 6 item scores are summed to yield a global score ranging from 36 to 78. A higher score means a worse outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in the Headache Impact Test (HIT-6) Global Score After 9 Weeks of Treatment
|
-5.1 score on a scale
Interval -6.6 to -3.6
|
-3.1 score on a scale
Interval -4.6 to -1.7
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
The PSQI has 19 items grouped into 7 component scores, each weighted equally on a 0-3 scale, The 7 component scores are summed to yield a global PSQI score, which has a range of 0-21. A higher score means a worse outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in the Pittsburgh Sleep Quality Index (PSQI) Global Score After 9 Weeks of Treatment
|
-0.7 score on a scale
Interval -1.3 to 0.0
|
-1.0 score on a scale
Interval -1.6 to -0.4
|
SECONDARY outcome
Timeframe: Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
The PGIC scale assesses patient overall change in the severity of illness following treatment. Participants rate how they feel now compared with how they felt before receiving study drug on a 7-point scale where 0 = "No change or condition has got worse" and 6 = "A great deal better." A higher score means a better outcome. For analyses, this variable was dichotomized: scores from 0 to 3 were combined in one category of "No" (no significant improvement) and scores from 4 to 6 were combined in another category of "Yes" (significant improvement with the study treatment).
Outcome measures
| Measure |
Propranolol ER
n=87 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=87 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Number of Participants Stratified Per Dichotomized Score From the Patient Global Impression of Change (PGIC) Scale After 9 Weeks of Treatment
No
|
46 Participants
|
60 Participants
|
|
Number of Participants Stratified Per Dichotomized Score From the Patient Global Impression of Change (PGIC) Scale After 9 Weeks of Treatment
Yes
|
41 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
The PSS assesses the frequency of 14 sources of stress on a scale from 0 = "never" to 4 = "very often." The item scores are summed to yield a global score ranging from 0 to 56. A higher score means a worse outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in the Perceived Stress Scale (PSS) Global Score After 9 Weeks of Treatment
|
-2.6 score on a scale
Interval -4.1 to -1.1
|
-1.9 score on a scale
Interval -3.4 to -0.5
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
The HADS is a 14-item assessment of anxiety (7 items) and depression (7 items) using the relative frequency of symptoms over the past week, rated on a 4-point scale ranging from 0 = "not at all" to 3 = "very often indeed". Responses are summed to provide separate scores for anxiety and depression with a range from 0 to 21. A higher score means a worse outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in the Hospital Anxiety and Depression Scale (HADS) Depression Score After 9 Weeks of Treatment
|
-1.0 score on a scale
Interval -1.6 to -0.4
|
-0.6 score on a scale
Interval -1.1 to 0.0
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
The HADS is a 14-item assessment of anxiety (7 items) and depression (7 items) using the relative frequency of symptoms over the past week, rated on a 4-point scale ranging from 0 = "not at all" to 3 = "very often indeed". Responses are summed to provide separate scores for anxiety and depression with a range from 0 to 21. A higher score means a worse outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in the Hospital Anxiety and Depression Scale (HADS) Anxiety Score After 9 Weeks of Treatment
|
-1.3 score on a scale
Interval -2.0 to -0.7
|
-0.7 score on a scale
Interval -1.3 to -0.1
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
The SCL-90R Somatization Scale is a 12-item assessment of somatic symptom distress over the past 7 days rated from 0 = "not at all" to 4 = "extremely." The scale score is computed as the mean for all items. The score range is from 0 to 4. A higher score means a worse outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in the Symptom Checklist 90-Revised (SCL-90R) Somatization Scale Score After 9 Weeks of Treatment
|
-0.2 score on a scale
Interval -0.3 to -0.1
|
-0.2 score on a scale
Interval -0.3 to -0.1
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
The SF-12v2 contains 7 questions assessing 8 domains of functioning and well-being rated from: "excellent" to "poor" (for general health); "yes, limited a lot" to "no, not limited at all" (for functional level); and "all of the time" to "none of the time" (for emotional state). These 8 domains can be further summarized into a physical component summary (PCS) and a mental component summary (MCS). summary (MCS). The range for each component is 0-100 and a higher score means a better outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in the SF-12 Health Survey v2 (SF-12v2) Physical Component Summary (PCS) After 9 Weeks of Treatment
|
1.2 score on a scale
Interval -0.3 to 2.6
|
0.3 score on a scale
Interval -1.2 to 1.7
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
The SF-12v2 contains 7 questions assessing 8 domains of functioning and well-being rated from: "excellent" to "poor" (for general health); "yes, limited a lot" to "no, not limited at all" (for functional level); and "all of the time" to "none of the time" (for emotional state). These 8 domains can be further summarized into a physical component summary (PCS) and a mental component summary (MCS). The range for each component is 0-100 and a higher score means a better outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in the SF-12 Health Survey v2 (SF-12v2) Mental Component Summary (MCS) After 9 Weeks of Treatment
|
3.6 score on a scale
Interval 1.6 to 5.6
|
2.8 score on a scale
Interval 0.9 to 4.8
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
Temperature values, measured in degrees Celsius, from 4 examiner-applied contact heat stimuli will be averaged to measure the experimental thermal pain threshold (temperature at which pain is first perceived). The range was 32-50 degrees Celsius and a higher value means a better outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in Thermal Pain Threshold After 9 Weeks of Treatment
|
1.3 degrees Celsius
Interval 0.7 to 1.9
|
0.5 degrees Celsius
Interval -0.1 to 1.1
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
Temperature values, measured in degrees Celsius, from 4 examiner-applied contact heat stimuli will be averaged to measure the experimental thermal pain tolerance (temperature at which pain can no longer be tolerated). The range was 32-50 degrees Celsius and a higher value means a better outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in Thermal Pain Tolerance After 9 Weeks of Treatment
|
0.5 degrees Celsius
Interval 0.2 to 0.9
|
0.4 degrees Celsius
Interval 0.0 to 0.8
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
Pressure values, measured in kilopascals (kPa), from up to 5 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle, are averaged to obtain a single pressure pain threshold value per anatomical site. The range is 0-500 kPa and a higher value means a better outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in Pressure Pain Threshold at Temporalis Muscle After 9 Weeks of Treatment
|
41.8 kPa
Interval 29.0 to 54.7
|
38.4 kPa
Interval 26.2 to 50.6
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/- 7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
Pressure values, measured in kilopascals, from up to 5 experimental pressure stimuli, bilaterally applied to the area of masseter muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in Pressure Pain Threshold at Masseter Muscle After 9 Weeks of Treatment
|
38.3 kPa
Interval 26.6 to 50.0
|
29.3 kPa
Interval 18.2 to 40.4
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
Pressure values, measured in kilopascals, from up to 5 experimental pressure stimuli, bilaterally applied to the area of temporomandibular joint, will be averaged to obtain a single pressure pain threshold value per anatomical site.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in Pressure Pain Threshold at Temporomandibular Joint After 9 Weeks of Treatment
|
36.8 kPa
Interval 26.6 to 47.0
|
25.3 kPa
Interval 15.4 to 35.1
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
Pressure values, measured in kilopascals, from up to 5 experimental pressure stimuli, bilaterally applied to the area of trapezius muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in Pressure Pain Threshold at Trapezius Muscle After 9 Weeks of Treatment
|
64.1 kPa
Interval 41.1 to 87.2
|
63.3 kPa
Interval 41.1 to 85.5
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
Pressure values, measured in kilopascals, from up to 5 experimental pressure stimuli, bilaterally applied to the area of lateral epicondyle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in Pressure Pain Threshold at Lateral Epicondyle After 9 Weeks of Treatment
|
41.4 kPa
Interval 22.2 to 60.7
|
22.7 kPa
Interval 4.0 to 41.5
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
Measured at TMD exam. A higher value means a better outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in Pain-free Jaw Opening After 9 Weeks of Treatment
|
4.5 mm
Interval 1.3 to 7.7
|
1.4 mm
Interval -1.6 to 4.4
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
Measured at TMD exam. A higher value means a better outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in Maximum Unassisted Jaw Opening After 9 Weeks of Treatment
|
-0.9 mm
Interval -3.2 to 1.4
|
-1.2 mm
Interval -3.4 to 0.9
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
Measured at TMD exam. A higher value means a better outcome.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in Maximum Assisted Jaw Opening After 9 Weeks of Treatment
|
-0.3 mm
Interval -2.3 to 1.8
|
-0.8 mm
Interval -2.7 to 1.1
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
Average of 3 repeated measures taken with a 2-minute interval.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in Systolic Blood Pressure After 9 Weeks of Treatment
|
-3.6 mm Hg
Interval -5.7 to -1.5
|
1.3 mm Hg
Interval -0.8 to 3.4
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
Average of 3 repeated measures taken with a 2-minute interval.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in Diastolic Blood Pressure After 9 Weeks of Treatment
|
-3.3 mm Hg
Interval -4.9 to -1.8
|
1.0 mm Hg
Interval -0.5 to 2.5
|
SECONDARY outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.
Average of 3 repeated measures taken with a 2-minute interval.
Outcome measures
| Measure |
Propranolol ER
n=100 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=99 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in Heart Rate After 9 Weeks of Treatment
|
-3.9 beats per minute
Interval -5.8 to -2.0
|
1.5 beats per minute
Interval -0.4 to 3.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication, provided at least one post-baseline outcome measure, and had genotyping data for COMT haplotypes.
Weekly mean pain index computed as the arithmetic mean of daily pain index values during the week prior to randomization and prior to each study visit. Daily pain index is computed as pain intensity (0-100 numeric rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable") multiplied by pain duration (0-100 percentage scale where percent = "percent of waking day you had facial pain") as reported in the Daily Symptom Diary, divided by 100. The pain index range is from 0 to 100. A higher score means a worse outcome. The pain index was stratified per number of catechol-O-methyltransferase (COMT) Low Pain Sensitive (LPS) haplotypes.
Outcome measures
| Measure |
Propranolol ER
n=82 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=85 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in the Weekly Mean Pain Index After 9 Weeks of Treatment Stratified Per Number of COMT LPS Haplotypes
2 LPS haplotypes
|
-15.2 units on a scale
Interval -23.3 to -7.0
|
-2.5 units on a scale
Interval -13.6 to 8.7
|
|
Change in the Weekly Mean Pain Index After 9 Weeks of Treatment Stratified Per Number of COMT LPS Haplotypes
0 LPS haplotypes
|
-14.2 units on a scale
Interval -19.3 to -9.2
|
-12.3 units on a scale
Interval -17.3 to -7.4
|
|
Change in the Weekly Mean Pain Index After 9 Weeks of Treatment Stratified Per Number of COMT LPS Haplotypes
1 LPS haplotype
|
-12.2 units on a scale
Interval -17.3 to -7.0
|
-13.2 units on a scale
Interval -17.9 to -8.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)Population: All participants who received at least one dose of study medication, provided at least one post-baseline outcome measure, and had genotyping data for COMT rs4680.
Weekly mean pain index computed as the arithmetic mean of daily pain index values during the week prior to randomization and prior to each study visit. Daily pain index is computed as pain intensity (0-100 numeric rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable") multiplied by pain duration (0-100 percentage scale where percent = "percent of waking day you had facial pain") as reported in the Daily Symptom Diary, divided by 100. The pain index range is from 0 to 100. A higher score means a worse outcome. The pain index was stratified per number of catechol-O-methyltransferase (COMT) valine alleles at single nucleotide polymorphism (SNP) rs4680.
Outcome measures
| Measure |
Propranolol ER
n=83 Participants
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=85 Participants
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Change in the Weekly Mean Pain Index After 9 Weeks of Treatment Stratified Per Number of COMT Valine Alleles at rs4680
0 valine alleles
|
-14.2 units on a scale
Interval -20.9 to -7.6
|
-13.9 units on a scale
Interval -21.5 to -6.3
|
|
Change in the Weekly Mean Pain Index After 9 Weeks of Treatment Stratified Per Number of COMT Valine Alleles at rs4680
1 valine allele
|
-13.9 units on a scale
Interval -19.2 to -8.6
|
-13.1 units on a scale
Interval -17.6 to -8.6
|
|
Change in the Weekly Mean Pain Index After 9 Weeks of Treatment Stratified Per Number of COMT Valine Alleles at rs4680
2 valine alleles
|
-14.3 units on a scale
Interval -19.7 to -9.0
|
-9.7 units on a scale
Interval -15.8 to -3.6
|
Adverse Events
Propranolol ER
Serious events: 4 serious events
Other events: 86 other events
Deaths: 1 deaths
Placebo
Serious events: 1 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Propranolol ER
n=100 participants at risk
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=100 participants at risk
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.0%
1/100 • Number of events 3 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
0.00%
0/100 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
1.0%
1/100 • Number of events 1 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
0.00%
0/100 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Psychiatric disorders
Mental status changes
|
1.0%
1/100 • Number of events 1 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
0.00%
0/100 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.0%
1/100 • Number of events 1 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
0.00%
0/100 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Psychiatric disorders
Depression
|
1.0%
1/100 • Number of events 1 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
0.00%
0/100 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Infections and infestations
Appendicitis
|
1.0%
1/100 • Number of events 1 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
0.00%
0/100 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Gastrointestinal disorders
Crohn's disease
|
1.0%
1/100 • Number of events 1 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
0.00%
0/100 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/100 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
1.0%
1/100 • Number of events 1 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/100 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
1.0%
1/100 • Number of events 1 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/100 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
1.0%
1/100 • Number of events 1 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Psychiatric disorders
Suicidal ideation
|
1.0%
1/100 • Number of events 1 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
0.00%
0/100 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
Other adverse events
| Measure |
Propranolol ER
n=100 participants at risk
Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).
Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
|
Placebo
n=100 participants at risk
Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).
Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
20/100 • Number of events 23 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
18.0%
18/100 • Number of events 22 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Gastrointestinal disorders
Nausea
|
19.0%
19/100 • Number of events 20 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
9.0%
9/100 • Number of events 9 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
10/100 • Number of events 13 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
10.0%
10/100 • Number of events 10 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
5/100 • Number of events 5 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
3.0%
3/100 • Number of events 3 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
General disorders
Fatigue
|
32.0%
32/100 • Number of events 38 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
21.0%
21/100 • Number of events 24 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Nervous system disorders
Dizziness
|
25.0%
25/100 • Number of events 31 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
9.0%
9/100 • Number of events 10 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Nervous system disorders
Paraesthesia
|
7.0%
7/100 • Number of events 8 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
13.0%
13/100 • Number of events 14 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Nervous system disorders
Hypoaestesia
|
6.0%
6/100 • Number of events 7 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
8.0%
8/100 • Number of events 8 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Nervous system disorders
Headache
|
5.0%
5/100 • Number of events 5 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
1.0%
1/100 • Number of events 1 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Nervous system disorders
Migraine
|
5.0%
5/100 • Number of events 7 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
0.00%
0/100 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Infections and infestations
Nasopharyngitis
|
13.0%
13/100 • Number of events 15 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
12.0%
12/100 • Number of events 12 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.0%
7/100 • Number of events 8 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
7.0%
7/100 • Number of events 7 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Psychiatric disorders
Insomnia
|
16.0%
16/100 • Number of events 20 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
12.0%
12/100 • Number of events 13 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Psychiatric disorders
Depression
|
10.0%
10/100 • Number of events 12 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
10.0%
10/100 • Number of events 11 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Psychiatric disorders
Sleep disorder
|
6.0%
6/100 • Number of events 8 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
2.0%
2/100 • Number of events 2 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
4/100 • Number of events 4 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
6.0%
6/100 • Number of events 6 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Injury, poisoning and procedural complications
Injury
|
10.0%
10/100 • Number of events 12 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
9.0%
9/100 • Number of events 10 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Ear and labyrinth disorders
Vertigo
|
6.0%
6/100 • Number of events 7 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
7.0%
7/100 • Number of events 7 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneos tissue disorders
|
6.0%
6/100 • Number of events 8 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
8.0%
8/100 • Number of events 8 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
7.0%
7/100 • Number of events 11 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
3.0%
3/100 • Number of events 5 • From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
8 AEs commonly reported with use of propranolol were solicited by a questionnaire administered at each study visit. All the rest of the AEs were solicited through the open-question inquiries at each study visit. Data are reported for AEs that occurred in the safety sample which includes all randomized participants who received at least one dose of study medication. Participants are analyzed according to the medication they actually received, regardless of their randomized assignment.
|
Additional Information
Dr. Inna E. Tchivileva
University of North Carolina at Chapel Hill
Phone: 1 919 537 3291
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place