Trial Outcomes & Findings for Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation (NCT NCT01901302)
NCT ID: NCT01901302
Last Updated: 2018-11-15
Results Overview
A Spontaneous Bowel Movement (SBM) Weekly Responder (calculated for each week of the 12-week double-blind treatment period) is a participant who has ≥ 3 SBMs for the week and an increase from baseline of ≥1 SBM for the specified week, based on at least 4 Available Data Days (ADDs) during the week. A Complete SBM (CSBM) Weekly Responder is a participant who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week. For the definition of the primary efficacy endpoint, Overall SBM Responder is a participant who is a Weekly SBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).
TERMINATED
PHASE3
61 participants
12 weeks
2018-11-15
Participant Flow
Due to difficulties with enrollment, this study was terminated early.
Participant milestones
| Measure |
CB-5945
0.25 milligrams (mg) CB-5945 administered orally twice daily (BID) for a 12-week treatment period
|
Placebo
Placebo administered orally BID for a 12-week treatment period
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
31
|
30
|
|
Overall Study
COMPLETED
|
4
|
7
|
|
Overall Study
NOT COMPLETED
|
27
|
23
|
Reasons for withdrawal
| Measure |
CB-5945
0.25 milligrams (mg) CB-5945 administered orally twice daily (BID) for a 12-week treatment period
|
Placebo
Placebo administered orally BID for a 12-week treatment period
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Study Terminated by Sponsor
|
23
|
20
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
Baseline characteristics by cohort
| Measure |
CB-5945
n=31 Participants
0.25 mg CB-5945 administered orally BID for a 12-week treatment period
|
Placebo
n=30 Participants
Placebo administered orally BID for a 12-week treatment period
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
LTE18
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
BTWN
|
31 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Age, Categorical
GTE65
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.
A Spontaneous Bowel Movement (SBM) Weekly Responder (calculated for each week of the 12-week double-blind treatment period) is a participant who has ≥ 3 SBMs for the week and an increase from baseline of ≥1 SBM for the specified week, based on at least 4 Available Data Days (ADDs) during the week. A Complete SBM (CSBM) Weekly Responder is a participant who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week. For the definition of the primary efficacy endpoint, Overall SBM Responder is a participant who is a Weekly SBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.
The CORGISS is designed to assess GI symptoms related to opioid use in patients with chronic non-cancer pain. The CORGISS asks participants to rate the severity of GI symptoms over the previous 24 hours, with answers ranging from 0 ("did not experience") to 4 ("very severe").
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.
A CSBM Weekly Responder is a participant who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week. An Overall CSBM Responder is a subject who is a Weekly CSBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through 16 weeksPopulation: All participants randomized to treatment who received ≥ 1 dose of double-blind study medication.
Cardiovascular (CV) events of interested included mycardial infarction, unstable angina, cardiovascular accident, congestive heart failure, serious arrhythmia, resuscitated cardiac arrest, and death. Gastrointestinal (GI) events of interest included emergency department visits for SAEs of gastroenteritis, hepatitis, pancreatitis, nausea, vomiting, diarrhea, and abdominal pain or cramping. Central opioid withdrawal events of interest included opioid withdrawal syndrome.
Outcome measures
| Measure |
CB-5945
n=31 Participants
0.25 mg CB-5945 administered orally BID for a 12-week treatment period
|
Placebo
n=30 Participants
Placebo administered orally BID for a 12-week treatment period
|
|---|---|---|
|
Adjudicated Cardiovascular, Gastrointestinal and Central Opioid Withdrawal Events
Subjects with at Least One Confirmed CV Event
|
0 participants
|
0 participants
|
|
Adjudicated Cardiovascular, Gastrointestinal and Central Opioid Withdrawal Events
Subjects with at Least One Confirmed GI Event
|
0 participants
|
0 participants
|
|
Adjudicated Cardiovascular, Gastrointestinal and Central Opioid Withdrawal Events
Subjects with at Least One Confirmed OW Event
|
0 participants
|
0 participants
|
Adverse Events
CB-5945
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CB-5945
n=31 participants at risk
0.25 mg CB-5945 administered orally BID for a 12-week treatment period
|
Placebo
n=30 participants at risk
Placebo administered orally BID for a 12-week treatment period
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/31 • Baseline through 16 weeks
|
3.3%
1/30 • Number of events 1 • Baseline through 16 weeks
|
|
Cardiac disorders
Tachycardia
|
3.2%
1/31 • Number of events 1 • Baseline through 16 weeks
|
0.00%
0/30 • Baseline through 16 weeks
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/31 • Baseline through 16 weeks
|
3.3%
1/30 • Number of events 1 • Baseline through 16 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/31 • Baseline through 16 weeks
|
3.3%
1/30 • Number of events 1 • Baseline through 16 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.2%
1/31 • Number of events 1 • Baseline through 16 weeks
|
0.00%
0/30 • Baseline through 16 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/31 • Baseline through 16 weeks
|
3.3%
1/30 • Number of events 1 • Baseline through 16 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
1/31 • Number of events 1 • Baseline through 16 weeks
|
3.3%
1/30 • Number of events 1 • Baseline through 16 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/31 • Baseline through 16 weeks
|
3.3%
1/30 • Number of events 1 • Baseline through 16 weeks
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/31 • Baseline through 16 weeks
|
3.3%
1/30 • Number of events 1 • Baseline through 16 weeks
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/31 • Baseline through 16 weeks
|
3.3%
1/30 • Number of events 1 • Baseline through 16 weeks
|
|
Gastrointestinal disorders
Nausea
|
3.2%
1/31 • Number of events 1 • Baseline through 16 weeks
|
3.3%
1/30 • Number of events 1 • Baseline through 16 weeks
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/31 • Baseline through 16 weeks
|
3.3%
1/30 • Number of events 1 • Baseline through 16 weeks
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
1/31 • Number of events 1 • Baseline through 16 weeks
|
0.00%
0/30 • Baseline through 16 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
1/31 • Number of events 1 • Baseline through 16 weeks
|
0.00%
0/30 • Baseline through 16 weeks
|
|
Infections and infestations
Urinary tract infection
|
3.2%
1/31 • Number of events 1 • Baseline through 16 weeks
|
3.3%
1/30 • Number of events 1 • Baseline through 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/31 • Baseline through 16 weeks
|
3.3%
1/30 • Number of events 1 • Baseline through 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
1/31 • Number of events 1 • Baseline through 16 weeks
|
0.00%
0/30 • Baseline through 16 weeks
|
|
Nervous system disorders
Headache
|
3.2%
1/31 • Number of events 1 • Baseline through 16 weeks
|
0.00%
0/30 • Baseline through 16 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.2%
1/31 • Number of events 1 • Baseline through 16 weeks
|
0.00%
0/30 • Baseline through 16 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.5%
2/31 • Number of events 2 • Baseline through 16 weeks
|
0.00%
0/30 • Baseline through 16 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/31 • Baseline through 16 weeks
|
3.3%
1/30 • Number of events 1 • Baseline through 16 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
3.2%
1/31 • Number of events 1 • Baseline through 16 weeks
|
3.3%
1/30 • Number of events 1 • Baseline through 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.2%
1/31 • Number of events 1 • Baseline through 16 weeks
|
0.00%
0/30 • Baseline through 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/31 • Baseline through 16 weeks
|
3.3%
1/30 • Number of events 1 • Baseline through 16 weeks
|
Additional Information
Vice President Clinical Research
Cubist Pharamceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER