Trial Outcomes & Findings for Cyclobenzaprine HCl Extended Release 15 mg Versus Placebo in Treatment of Cervical and/or Lower Back Pain Due to Muscle Spasms of Local Origin (NCT NCT02814565)
NCT ID: NCT02814565
Last Updated: 2019-04-08
Results Overview
Participants assessed the study medication helpfulness on a daily basis (in the daily diary), using the following 5-point rating scale: "How would you rate this study medication in improving your condition?" "0 = poor", "1 = fair", "2 = good", "3 = very good", "4 = excellent".
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
180 participants
Primary outcome timeframe
Day 3
Results posted on
2019-04-08
Participant Flow
Participants took part in the study at 10 investigative sites in the Russian Federation from 12 October 2016 to 14 March 2017.
Participants with a diagnosis of acute cervical and/or lower back pain due to muscle spasms of local origin were enrolled equally in one of two treatment groups: Cyclobenzaprine HCl 15 mg or placebo.
Participant milestones
| Measure |
Cyclobenzaprine HCl 15 mg
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
|
Placebo
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
90
|
|
Overall Study
COMPLETED
|
89
|
88
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Cyclobenzaprine HCl 15 mg
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
|
Placebo
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Subject decision, caused by AE Influenza
|
1
|
1
|
Baseline Characteristics
Cyclobenzaprine HCl Extended Release 15 mg Versus Placebo in Treatment of Cervical and/or Lower Back Pain Due to Muscle Spasms of Local Origin
Baseline characteristics by cohort
| Measure |
Cyclobenzaprine HCl 15 mg
n=90 Participants
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
|
Placebo
n=90 Participants
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.0 years
STANDARD_DEVIATION 9.0 • n=93 Participants
|
31.5 years
STANDARD_DEVIATION 9.2 • n=4 Participants
|
32.3 years
STANDARD_DEVIATION 9.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=93 Participants
|
62 Participants
n=4 Participants
|
110 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
70 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
European (Caucasian)
|
90 Participants
n=93 Participants
|
90 Participants
n=4 Participants
|
180 Participants
n=27 Participants
|
|
Region of Enrollment
Russia
|
90 Participants
n=93 Participants
|
90 Participants
n=4 Participants
|
180 Participants
n=27 Participants
|
|
Smoking Status
Never smoked
|
78 Participants
n=93 Participants
|
79 Participants
n=4 Participants
|
157 Participants
n=27 Participants
|
|
Smoking Status
Former smoker
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Smoking Status
Current smoker
|
11 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Height
|
171.8 cm
STANDARD_DEVIATION 8.2 • n=93 Participants
|
169.1 cm
STANDARD_DEVIATION 7.6 • n=4 Participants
|
170.5 cm
STANDARD_DEVIATION 8.0 • n=27 Participants
|
|
Weight
|
71.05 kg
STANDARD_DEVIATION 14.53 • n=93 Participants
|
66.22 kg
STANDARD_DEVIATION 13.61 • n=4 Participants
|
68.64 kg
STANDARD_DEVIATION 14.25 • n=27 Participants
|
PRIMARY outcome
Timeframe: Day 3Population: FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
Participants assessed the study medication helpfulness on a daily basis (in the daily diary), using the following 5-point rating scale: "How would you rate this study medication in improving your condition?" "0 = poor", "1 = fair", "2 = good", "3 = very good", "4 = excellent".
Outcome measures
| Measure |
Cyclobenzaprine HCl 15 mg
n=90 Participants
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
|
Placebo
n=90 Participants
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
|
|---|---|---|
|
Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment
Day 3, 0=poor
|
20.0 percentage of participants
|
28.9 percentage of participants
|
|
Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment
Day 3, 1=fair
|
60.0 percentage of participants
|
46.7 percentage of participants
|
|
Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment
Day 3, 2=good
|
16.7 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment
Day 3, 3=very good
|
3.3 percentage of participants
|
2.2 percentage of participants
|
|
Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment
Day 3, 4=excellent
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Days 7 and 14Population: FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
Participants assessed the study medication helpfulness on a daily basis (in the daily diary), using the following 5-point rating scale: "How would you rate this study medication in improving your condition?" "0 = poor", "1 = fair", "2 = good", "3 = very good", "4 = excellent".
Outcome measures
| Measure |
Cyclobenzaprine HCl 15 mg
n=90 Participants
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
|
Placebo
n=90 Participants
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
|
|---|---|---|
|
Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment
Day 7, 3=very good
|
13.3 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment
Day 14, 1=fair
|
25.6 percentage of participants
|
25.6 percentage of participants
|
|
Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment
Day 7, 0=poor
|
7.8 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment
Day 7, 1=fair
|
41.1 percentage of participants
|
34.4 percentage of participants
|
|
Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment
Day 7, 2=good
|
35.6 percentage of participants
|
34.4 percentage of participants
|
|
Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment
Day 7, 4=excellent
|
2.2 percentage of participants
|
3.3 percentage of participants
|
|
Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment
Day 14, 0=poor
|
8.9 percentage of participants
|
14.4 percentage of participants
|
|
Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment
Day 14, 2=good
|
25.6 percentage of participants
|
28.9 percentage of participants
|
|
Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment
Day 14, 3=very good
|
22.2 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment
Day 14, 4=excellent
|
17.8 percentage of participants
|
11.1 percentage of participants
|
SECONDARY outcome
Timeframe: Day 3Population: FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
The investigator assessed their clinical global impression of change compared to Baseline, based on physical examination, degree of muscle spasm (presence of muscle spasm assessment), reaction to palpation (presence of local pain assessment), limitation of range of motion, and evaluation of the patient's reported functional assessment (limitation of activities of daily living assessment). The following 5-point rating scale was used: "1 = worse", "2 = no change", "3 = slight improvement", "4 = moderate improvement", "5 = marked improvement".
Outcome measures
| Measure |
Cyclobenzaprine HCl 15 mg
n=90 Participants
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
|
Placebo
n=90 Participants
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
|
|---|---|---|
|
Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment
Day 3, 4=moderate improvement
|
11.1 percentage of participants
|
3.3 percentage of participants
|
|
Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment
Day 3, 1=worse
|
1.1 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment
Day 3, 2=no change
|
52.2 percentage of participants
|
68.9 percentage of participants
|
|
Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment
Day 3, 3=slight improvement
|
35.6 percentage of participants
|
25.6 percentage of participants
|
|
Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment
Day 3, 5=marked improvement
|
0.0 percentage of participants
|
2.2 percentage of participants
|
SECONDARY outcome
Timeframe: Days 7 and 15Population: FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
The investigator assessed their clinical global impression of change compared to Baseline, based on physical examination, degree of muscle spasm (presence of muscle spasm assessment), reaction to palpation (presence of local pain assessment), limitation of range of motion, and evaluation of the patient's reported functional assessment (limitation of activities of daily living assessment). The following 5-point rating scale was used: "1 = worse", "2 = no change", "3 = slight improvement", "4 = moderate improvement", "5 = marked improvement".
Outcome measures
| Measure |
Cyclobenzaprine HCl 15 mg
n=90 Participants
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
|
Placebo
n=90 Participants
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
|
|---|---|---|
|
Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment
Day 7, 3=slight improvement
|
52.2 percentage of participants
|
44.4 percentage of participants
|
|
Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment
Day 15, 1=worse
|
1.1 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment
Day 15, 2=no change
|
5.6 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment
Day 15, 3=slight improvement
|
27.8 percentage of participants
|
34.4 percentage of participants
|
|
Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment
Day 7, 1=worse
|
2.2 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment
Day 7, 2=no change
|
8.9 percentage of participants
|
26.7 percentage of participants
|
|
Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment
Day 7, 4=moderate improvement
|
27.8 percentage of participants
|
24.4 percentage of participants
|
|
Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment
Day 7, 5=marked improvement
|
8.9 percentage of participants
|
4.4 percentage of participants
|
|
Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment
Day 15, 4=moderate improvement
|
30.0 percentage of participants
|
32.2 percentage of participants
|
|
Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment
Day 15, 5=marked improvement
|
35.6 percentage of participants
|
21.1 percentage of participants
|
SECONDARY outcome
Timeframe: Days 3, 7, and 14Population: FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
Participants assessed their clinical global impression based on relief from local pain, restriction in activities of daily living, restriction of movement and intensity of local pain on a daily basis. The following 5-point rating scale was used: "1 = worse", "2 = no change", "3 = slight improvement", "4 = moderate improvement", "5 = marked improvement".
Outcome measures
| Measure |
Cyclobenzaprine HCl 15 mg
n=90 Participants
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
|
Placebo
n=90 Participants
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
|
|---|---|---|
|
Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment
Day 14, 4=moderate improvement
|
27.8 percentage of participants
|
28.9 percentage of participants
|
|
Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment
Day 3, 1=worse
|
3.3 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment
Day 3, 2=no change
|
45.6 percentage of participants
|
56.7 percentage of participants
|
|
Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment
Day 3, 3=slight improvement
|
47.8 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment
Day 3, 4=moderate improvement
|
3.3 percentage of participants
|
7.8 percentage of participants
|
|
Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment
Day 3, 5=marked improvement
|
0.0 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment
Day 7, 1=worse
|
4.4 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment
Day 7, 2=no change
|
13.3 percentage of participants
|
25.6 percentage of participants
|
|
Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment
Day 7, 3=slight improvement
|
52.2 percentage of participants
|
43.3 percentage of participants
|
|
Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment
Day 7, 4=moderate improvement
|
22.2 percentage of participants
|
25.6 percentage of participants
|
|
Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment
Day 7, 5=marked improvement
|
7.8 percentage of participants
|
4.4 percentage of participants
|
|
Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment
Day 14, 1=worse
|
1.1 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment
Day 14, 2=no change
|
14.4 percentage of participants
|
26.7 percentage of participants
|
|
Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment
Day 14, 3=slight improvement
|
24.4 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment
Day 14, 5=marked improvement
|
32.2 percentage of participants
|
23.3 percentage of participants
|
SECONDARY outcome
Timeframe: Days 3, 7, and 14Population: FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
A responder was defined as a participant who had both a rating of either "very good" or "excellent" for the participant's rating of medication helpfulness.
Outcome measures
| Measure |
Cyclobenzaprine HCl 15 mg
n=90 Participants
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
|
Placebo
n=90 Participants
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
|
|---|---|---|
|
Percentage of Responders on Days 3, 7, and 14 of Treatment
Day 3
|
3.3 percentage of participants
|
2.2 percentage of participants
|
|
Percentage of Responders on Days 3, 7, and 14 of Treatment
Day 7
|
15.6 percentage of participants
|
14.4 percentage of participants
|
|
Percentage of Responders on Days 3, 7, and 14 of Treatment
Day 14
|
40.0 percentage of participants
|
31.1 percentage of participants
|
SECONDARY outcome
Timeframe: Days 3, 7, and 15Population: FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
The investigator assessment based on physical examination, presence of muscle spasm (presence of muscle spasm assessment). The following 5-point rating scale was used: "1 = none", "2 = mild", "3 = moderate", "4 = moderately severe", "5 = severe".
Outcome measures
| Measure |
Cyclobenzaprine HCl 15 mg
n=90 Participants
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
|
Placebo
n=90 Participants
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
|
|---|---|---|
|
Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment
Day 3, 1=none
|
2.2 percentage of participants
|
2.2 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment
Day 3, 2=mild
|
27.8 percentage of participants
|
21.1 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment
Day 3, 5=severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment
Day 15, 1=none
|
48.9 percentage of participants
|
32.2 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment
Day 15, 2=mild
|
37.8 percentage of participants
|
47.8 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment
Day 3, 3=moderate
|
62.2 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment
Day 3, 4=moderately severe
|
7.8 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment
Day 7, 1=none
|
14.4 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment
Day 7, 2=mild
|
47.8 percentage of participants
|
53.3 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment
Day 7, 3=moderate
|
37.8 percentage of participants
|
38.9 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment
Day 7, 4=moderately severe
|
0.0 percentage of participants
|
2.2 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment
Day 7, 5=severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment
Day 15, 3=moderate
|
13.3 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment
Day 15, 4=moderately severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment
Day 15, 5=severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Days 3, 7, and 15Population: FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
The investigator assessed local pain based on physical examination, reaction to palpation (presence of local pain assessment). The following 5-point rating scale was used: "1 = none", "2 = mild", "3 = moderate", "4 = moderately severe", "5 = severe".
Outcome measures
| Measure |
Cyclobenzaprine HCl 15 mg
n=90 Participants
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
|
Placebo
n=90 Participants
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
|
|---|---|---|
|
Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment
Day 3, 1=none
|
1.1 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment
Day 3, 2=mild
|
24.4 percentage of participants
|
21.1 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment
Day 3, 4=moderately severe
|
7.8 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment
Day 7, 2=mild
|
55.6 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment
Day 7, 3=moderate
|
36.7 percentage of participants
|
46.7 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment
Day 15, 1=none
|
35.6 percentage of participants
|
25.6 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment
Day 15, 2=mild
|
51.1 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment
Day 15, 3=moderate
|
12.2 percentage of participants
|
24.4 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment
Day 3, 3=moderate
|
66.7 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment
Day 3, 5=severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment
Day 7, 1=none
|
6.7 percentage of participants
|
2.2 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment
Day 7, 4=moderately severe
|
1.1 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment
Day 7, 5=severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment
Day 15, 4=moderately severe
|
1.1 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment
Day 15, 5=severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Days 3, 7, and 15Population: FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
The investigator assessed limitation of range of motion. The following 5-point rating scale was used: "1 = none", "2 = mild", "3 = moderate", "4 = moderately severe", "5 = severe".
Outcome measures
| Measure |
Cyclobenzaprine HCl 15 mg
n=90 Participants
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
|
Placebo
n=90 Participants
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
|
|---|---|---|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment
Day 3, 4=moderately severe
|
5.6 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment
Day 3, 5=severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment
Day 7, 1=none
|
22.2 percentage of participants
|
13.3 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment
Day 7, 2=mild
|
51.1 percentage of participants
|
51.1 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment
Day 7, 3=moderate
|
26.7 percentage of participants
|
35.6 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment
Day 15, 1=none
|
44.4 percentage of participants
|
38.9 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment
Day 15, 4=moderately severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment
Day 3, 1=none
|
6.7 percentage of participants
|
4.4 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment
Day 3, 2=mild
|
40.0 percentage of participants
|
37.8 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment
Day 3, 3=moderate
|
47.8 percentage of participants
|
52.2 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment
Day 7, 4=moderately severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment
Day 7, 5=severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment
Day 15, 2=mild
|
48.9 percentage of participants
|
47.8 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment
Day 15, 3=moderate
|
6.7 percentage of participants
|
13.3 percentage of participants
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment
Day 15, 5=severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Days 3, 7, and 15Population: FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
The investigator assessed limitation of activities based on evaluation of the patient's reported functional assessment. The following 5-point rating scale was used: "1 = none", "2 = mild", "3 = moderate", "4 = moderately severe", "5 = severe".
Outcome measures
| Measure |
Cyclobenzaprine HCl 15 mg
n=90 Participants
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
|
Placebo
n=90 Participants
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
|
|---|---|---|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment
Day 7, 1=none
|
18.9 percentage of percentage
|
10.0 percentage of percentage
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment
Day 7, 2=mild
|
62.2 percentage of percentage
|
63.3 percentage of percentage
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment
Day 15, 5=severe
|
0.0 percentage of percentage
|
0.0 percentage of percentage
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment
Day 3, 1=none
|
4.4 percentage of percentage
|
5.6 percentage of percentage
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment
Day 3, 2=mild
|
46.7 percentage of percentage
|
50.0 percentage of percentage
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment
Day 3, 3=moderate
|
46.7 percentage of percentage
|
38.9 percentage of percentage
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment
Day 3, 4=moderately severe
|
2.2 percentage of percentage
|
5.6 percentage of percentage
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment
Day 3, 5=severe
|
0.0 percentage of percentage
|
0.0 percentage of percentage
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment
Day 7, 3=moderate
|
17.8 percentage of percentage
|
26.7 percentage of percentage
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment
Day 7, 4=moderately severe
|
1.1 percentage of percentage
|
0.0 percentage of percentage
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment
Day 7, 5=severe
|
0.0 percentage of percentage
|
0.0 percentage of percentage
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment
Day 15, 1=none
|
50.0 percentage of percentage
|
41.1 percentage of percentage
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment
Day 15, 2=mild
|
45.6 percentage of percentage
|
53.3 percentage of percentage
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment
Day 15, 3=moderate
|
4.4 percentage of percentage
|
5.6 percentage of percentage
|
|
Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment
Day 15, 4=moderately severe
|
0.0 percentage of percentage
|
0.0 percentage of percentage
|
Adverse Events
Cyclobenzaprine HCl 15 mg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cyclobenzaprine HCl 15 mg
n=90 participants at risk
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
|
Placebo
n=90 participants at risk
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
1.1%
1/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
6/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.1%
1/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
1.1%
1/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.2%
2/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Toothache
|
1.1%
1/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Influenza
|
1.1%
1/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.1%
1/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Rhinitis
|
1.1%
1/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
1.1%
1/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dysgeusia
|
1.1%
1/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.1%
1/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Poor quality sleep
|
1.1%
1/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.2%
2/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Anxiety
|
1.1%
1/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Disruptive mood dysregulation disorder
|
1.1%
1/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Sleep disorder
|
1.1%
1/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Somnolence
|
20.0%
18/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
5/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.1%
1/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.1%
1/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.1%
1/90 • First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER