Trial Outcomes & Findings for Study to Test the Effectiveness of Controlled-Release OROS® Hydromorphone HCl Compared to Placebo in Patients With Chronic Low Back Pain (NCT NCT00549042)
NCT ID: NCT00549042
Last Updated: 2020-06-17
Results Overview
Participants rate their pain intensity on a numeric rating scale (NRS), where 0=no pain and 10=worst possible pain, in a daily diary. At Week 12 (or final visit), all measurements during the preceding week are averaged, and the mean change from the mean score at baseline is calculated.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
459 participants
Primary outcome timeframe
Baseline, Week 12 (or final visit)
Results posted on
2020-06-17
Participant Flow
Participant milestones
| Measure |
OROS Hydromorphone
OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg
|
Placebo
Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase).
|
|---|---|---|
|
Conversion and Titration Phase
STARTED
|
459
|
0
|
|
Conversion and Titration Phase
COMPLETED
|
268
|
0
|
|
Conversion and Titration Phase
NOT COMPLETED
|
191
|
0
|
|
Double-blind Phase
STARTED
|
134
|
134
|
|
Double-blind Phase
COMPLETED
|
66
|
44
|
|
Double-blind Phase
NOT COMPLETED
|
68
|
90
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Test the Effectiveness of Controlled-Release OROS® Hydromorphone HCl Compared to Placebo in Patients With Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
OROS Hydromorphone
n=134 Participants
OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg
|
Placebo
n=134 Participants
Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase).
|
Total
n=268 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
129 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 10.51 • n=5 Participants
|
49.5 years
STANDARD_DEVIATION 10.55 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 10.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
134 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
268 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12 (or final visit)Population: Intent-to-treat population (ITT). One patient (randomized to receive OROS hydromorphone) did not report taking any study medication, and another (randomized to receive placebo) did not have Baseline values for the primary efficacy variable; both were excluded from the ITT population. Therefore, the ITT population had 266 patients.
Participants rate their pain intensity on a numeric rating scale (NRS), where 0=no pain and 10=worst possible pain, in a daily diary. At Week 12 (or final visit), all measurements during the preceding week are averaged, and the mean change from the mean score at baseline is calculated.
Outcome measures
| Measure |
OROS Hydromorphone
n=133 Participants
OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg
|
Placebo
n=133 Participants
Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase).
|
|---|---|---|
|
Change From Baseline to Week 12 in Mean Pain Intensity
|
0.6 score on a scale
Interval -5.0 to 5.0
|
1.7 score on a scale
Interval -3.0 to 7.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through Week 12Population: Results are not presented for Other, prespecified outcome measures
Participants rate their pain on the pain intensity NRS in a daily diary. At each scheduled visit all measurements during the preceding week are collected, and a mean score for each arm is calculated for each visit. Mean scores at baseline and each subsequent visit are plotted on a graph for the entire 12-week treatment period, and an area under the curve calculation is used to determine the mean change from baseline for each arm through the entire 12-week treatment phase.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through Week 12Population: Results are not presented for Other, prespecified outcome measures
Change from Baseline in mean PGA scores collected at each visit (at Baseline, Days 1, 4, 8, 11, and Weeks 2, 3, 4, 6, 8, 10, and 12) using the scale: 1=Excellent, 2=Very Good, 3=Good, 4=Fair, and 5=Poor. The worst possible score is 5.0.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through Week 12Population: Results are not presented for Other, prespecified outcome measures
Change from baseline in the Roland-Morris Disability Questionnaire (RDQ) score was analyzed for each visit at which the RDQ was administered (Days 1, 8, and Weeks 2, 3, 4, 6, 8, 10, and 12). This is a 24-item inventory with scores ranging from 0 (highest ability) to 24 (lowest ability). Higher scores mean more disability.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through Week 12Population: Results are not presented for Other, prespecified outcome measures
Participants rate their pain on the pain intensity NRS at each scheduled visit (Baseline, Days 1, 4, 8, 11, and Weeks 2, 3, 4, 6, 8, 10, and 12), and a mean score is calculated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: within 12 weeksPopulation: Results are not presented for Other, prespecified outcome measures
Time to treatment failure is the median number of days from baseline until the earliest day on which the patient's data indicated treatment failure.
Outcome measures
Outcome data not reported
Adverse Events
Conversion and Titration Phase
Serious events: 5 serious events
Other events: 247 other events
Deaths: 0 deaths
OROS Hydromorphone
Serious events: 6 serious events
Other events: 64 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Conversion and Titration Phase
n=447 participants at risk
OROS hydromorphone 12, 16, 24, 32, 40, 48, or 64 m
|
OROS Hydromorphone
n=134 participants at risk
OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg
|
Placebo
n=134 participants at risk
Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase).
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.75%
1/134 • Number of events 1
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.75%
1/134 • Number of events 1
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Gastrointestinal disorders
Nausea
|
0.22%
1/447 • Number of events 1
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Gastrointestinal disorders
Vomiting
|
0.22%
1/447 • Number of events 1
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.75%
1/134 • Number of events 1
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
General disorders
Dehydration
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.75%
1/134 • Number of events 1
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
1.5%
2/134 • Number of events 2
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.75%
1/134 • Number of events 1
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
1.5%
2/134 • Number of events 2
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.75%
1/134 • Number of events 1
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Infections and infestations
Meningitis herpes
|
0.22%
1/447 • Number of events 1
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Infections and infestations
Pneumonia
|
0.22%
1/447 • Number of events 1
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Investigations
Diabetic ketoacidosi
|
0.22%
1/447 • Number of events 1
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Investigations
Hypokalaemia
|
0.22%
1/447 • Number of events 1
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Nervous system disorders
Dizziness
|
0.22%
1/447 • Number of events 2
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Nervous system disorders
Vertigo
|
0.22%
1/447 • Number of events 1
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.75%
1/134 • Number of events 1
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.75%
1/134 • Number of events 1
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.75%
1/134 • Number of events 1
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.75%
1/134 • Number of events 1
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Renal and urinary disorders
Possible kidney stone
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.75%
1/134 • Number of events 1
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.75%
1/134 • Number of events 1
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Vascular disorders
Deep vein thrombosis
|
0.22%
1/447 • Number of events 1
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.75%
1/134 • Number of events 1
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
Other adverse events
| Measure |
Conversion and Titration Phase
n=447 participants at risk
OROS hydromorphone 12, 16, 24, 32, 40, 48, or 64 m
|
OROS Hydromorphone
n=134 participants at risk
OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg
|
Placebo
n=134 participants at risk
Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase).
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
1.5%
2/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
2.2%
3/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
2.2%
3/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Gastrointestinal disorders
Constipation
|
15.4%
69/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
7.5%
10/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
3.7%
5/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
13/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
3.7%
5/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
6.7%
9/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Gastrointestinal disorders
Dry mouth
|
2.9%
13/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Gastrointestinal disorders
Nausea
|
11.9%
53/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
9.0%
12/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
7.5%
10/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
29/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
6.0%
8/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
4.5%
6/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
General disorders
Chills
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
1.5%
2/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
2.2%
3/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
General disorders
Pain
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.75%
1/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
2.2%
3/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
General disorders
Drug withdrawal syndrome
|
4.9%
22/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
9.7%
13/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
11.9%
16/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
General disorders
Fatigue
|
3.6%
16/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.75%
1/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
3.0%
4/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
General disorders
Oedema peripheral
|
2.9%
13/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
2.2%
3/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.75%
1/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Infections and infestations
Influenza
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
3.0%
4/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
1.5%
2/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
4.5%
6/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.75%
1/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Infections and infestations
URT infection
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
3.0%
4/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
2.2%
3/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
3.0%
4/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
1.5%
2/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Investigations
Weight decreased
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
3.0%
4/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
2.2%
3/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
2.2%
3/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.75%
1/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
1.5%
2/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
2.2%
3/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
9/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
6.0%
8/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
2.2%
3/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
13/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
4.5%
6/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
6.0%
8/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Nervous system disorders
Tremor
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.75%
1/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
2.2%
3/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Nervous system disorders
Dizziness
|
3.8%
17/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
2.2%
3/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
1.5%
2/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Nervous system disorders
Headache
|
7.8%
35/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
5.2%
7/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
7.5%
10/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Nervous system disorders
Somnolence
|
8.7%
39/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Psychiatric disorders
Anxiety
|
2.0%
9/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
3.0%
4/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Psychiatric disorders
Insomnia
|
2.9%
13/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
2.2%
3/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
3.7%
5/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
2.2%
3/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
1.5%
2/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.9%
13/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.7%
21/447
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
0.00%
0/134
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=447). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 459.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place