Trial Outcomes & Findings for Evaluation of the Efficacy and Safety of ADL5945 Once Daily for the Treatment of Opioid-induced Constipation in Adults Taking Opioid Therapy for Chronic Noncancer Pain (NCT NCT01275755)
NCT ID: NCT01275755
Last Updated: 2018-11-15
Results Overview
An SBM was defined as a bowel movement (BM) with no laxative use in the previous 24 hours. Each weekly SBM average was calculated as follows: (7 × number of SBMs) / (number of days with nonmissing data). The overall SBM rate for the 4-week double-blind treatment period was calculated as follows: (the average of the first week + the average of the second week + the average of the third week + the average of the fourth week) / 4.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
Baseline, Weeks 1 through 4 of treatment
Results posted on
2018-11-15
Participant Flow
Participant milestones
| Measure |
Placebo
Each participant received 1 placebo capsule orally every day (QD) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
|
ADL5945 0.25 mg
During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-milligrams (mg) ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
|
|---|---|---|
|
Run-in Placebo Period
STARTED
|
41
|
40
|
|
Run-in Placebo Period
COMPLETED
|
41
|
40
|
|
Run-in Placebo Period
NOT COMPLETED
|
0
|
0
|
|
Double-blind Treatment Period
STARTED
|
41
|
40
|
|
Double-blind Treatment Period
Received at Least 1 Dose of Study Drug
|
41
|
40
|
|
Double-blind Treatment Period
COMPLETED
|
39
|
37
|
|
Double-blind Treatment Period
NOT COMPLETED
|
2
|
3
|
|
Run-out Placebo Period
STARTED
|
39
|
37
|
|
Run-out Placebo Period
COMPLETED
|
38
|
37
|
|
Run-out Placebo Period
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Each participant received 1 placebo capsule orally every day (QD) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
|
ADL5945 0.25 mg
During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-milligrams (mg) ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
|
|---|---|---|
|
Double-blind Treatment Period
Adverse Event
|
0
|
2
|
|
Double-blind Treatment Period
Lost to Follow-up
|
1
|
1
|
|
Double-blind Treatment Period
Withdrawal by Subject
|
1
|
0
|
|
Run-out Placebo Period
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Evaluation of the Efficacy and Safety of ADL5945 Once Daily for the Treatment of Opioid-induced Constipation in Adults Taking Opioid Therapy for Chronic Noncancer Pain
Baseline characteristics by cohort
| Measure |
Placebo
n=41 Participants
Each participant received 1 placebo capsule orally QD during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
|
ADL5945 0.25mg
n=40 Participants
During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
LTE18
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
BTWN
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Age, Categorical
GTE65
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 1 through 4 of treatmentPopulation: All participants who were randomized to study treatment and had at least 1 evaluable SBM post-dose measurement during the Double-blind Treatment Period. Last-observation-carried-forward (LOCF) was used to impute missing postbaseline values.
An SBM was defined as a bowel movement (BM) with no laxative use in the previous 24 hours. Each weekly SBM average was calculated as follows: (7 × number of SBMs) / (number of days with nonmissing data). The overall SBM rate for the 4-week double-blind treatment period was calculated as follows: (the average of the first week + the average of the second week + the average of the third week + the average of the fourth week) / 4.
Outcome measures
| Measure |
Placebo
n=41 Participants
Each participant received 1 placebo capsule orally QD during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
|
ADL5945 0.25 mg
n=40 Participants
During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
|
|---|---|---|
|
Change From Baseline in the Weekly Average of Spontaneous Bowel Movements (SBMs) During Treatment
|
1.40 Number of SBMs/week
Standard Error 0.26
|
2.58 Number of SBMs/week
Standard Error 0.34
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
ADL5945 0.25 mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=41 participants at risk
Each participant received 1 placebo capsule orally every day (QD) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
|
ADL5945 0.25 mg
n=40 participants at risk
During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-milligrams (mg) ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
|
|---|---|---|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=41 participants at risk
Each participant received 1 placebo capsule orally every day (QD) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
|
ADL5945 0.25 mg
n=40 participants at risk
During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-milligrams (mg) ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
2.4%
1/41 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
7.3%
3/41 • Number of events 3
|
5.0%
2/40 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
2.4%
1/41 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/41
|
5.0%
2/40 • Number of events 2
|
|
Nervous system disorders
Headache
|
4.9%
2/41 • Number of events 2
|
0.00%
0/40
|
|
Gastrointestinal disorders
Nausea
|
4.9%
2/41 • Number of events 2
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
2.4%
1/41 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/41 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
Additional Information
Vice President, Clinical Research
Cubist Pharmaceuticals
Phone: (781) 860-8660
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER