Phase 3
N=460
Study Evaluating Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic Non-Malignant Pain
Constipation
Bottom Line
View on ClinicalTrials.gov: NCT00529087 ↗Enrolled (actual)
460
Serious AEs
1.5%
Results posted
May 2010
Primary outcome: Primary: Percentage of Patients Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours of the First Dose — 34.2; 9.9 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- N-methylnaltrexone bromide (MOA-728) (Drug); placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours of the First Dose |
34.2; 9.9 | <0.001 sig |
| PRIMARY Percentage of Active Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 4 Hours of Injection During the Double-blind Period |
28.9; 30.2; 9.3; 9.4 | <0.001 sig |
| SECONDARY Time to the First Rescue-free Bowel Movement (RFBM) After First Dose |
46.0; 25.3 | <0.001 sig |
| SECONDARY Change From Baseline in Weekly Number of Rescue-free Bowel Movements (RFBM) for the Double-blind Period at 4 Weeks |
3.1; 2.1; 1.5 | <0.001 sig |
| SECONDARY Weekly Number of Rescue-free Bowel Movements (RFBM) (Open-label Period) |
3.7 | — |
| SECONDARY Percentage of Patients Achieving at Least 3 Rescue-free Bowel Movements (RFBM) Per Week in Double-blind Period |
58.7; 45.3; 38.3 | <0.001 sig |
| SECONDARY Percentage of Active Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 1, 2, 3 and 6 Hour(s) in Double-blind Period |
17.8; 17.3; 3.3; 3.2; 24.2; 24.1 | <0.001 sig |
| SECONDARY Percentage of Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 1, 2, 3, 4 and 6 Hours in Double-blind Period |
17.8; 11.3; 3.3; 24.2; 16.2; 5.8 | <0.001 sig |
| SECONDARY Percentage of Patients With a Weekly Rescue-free Bowel Movement (RFBM) Rate ≥ 3 and an Increase of at Least 1 in the Weekly RFBM Rate From Baseline for the Double-blind Period |
58.7; 43.2; 37.7 | <0.001 sig |
| SECONDARY Percentage of Patients With an Increase of at Least 1 in the Weekly Rescue-free Bowel Movement (RFBM) Rate From Baseline for the Double-blind Period at 4 Weeks |
74.7; 68.2; 54.9 | <0.001 sig |
| SECONDARY Change in Weekly Number of Bowel Movements During Double-blind Period |
2.7; 1.7; 1.3 | <0.001 sig |
| SECONDARY Change From Baseline in Weekly Number of Quality Rescue-free Bowel Movements (RFBM) |
2.4; 1.7; 1.3 | <0.001 sig |
| SECONDARY Change in Weekly Number of Complete Rescue-free Bowel Movements (RFBM) |
1.9; 1.2; 0.8 | <0.001 sig |
| SECONDARY Change in Bristol Stool Form Scale Score for Rescue-free Bowel Movements (RFBM) |
1.4; 1.2; 0.9 | 0.002 sig |
| SECONDARY Change in Straining Scale Score of Rescue-free Bowel Movements (RFBM) From Baseline During Double-blind Period |
-1.1; -1.1; -0.8 | 0.008 sig |
| SECONDARY Percentage of Patients With Improvement in Bristol Stool Form Scale Score for Rescue-free Bowel Movements (RFBM) by 1 Point During Open Label Period |
57.9 | — |
| SECONDARY Percentage of Patients With Improvement in Straining Scale Score for Rescue-free Bowel Movements (RFBM) by 1 Point During Open Label Period |
55.4 | — |
| SECONDARY Change in Percentage of Rescue-free Bowel Movements (RFBM) With Bristol Stool Form Scale in Type 3 or Type 4 From Baseline During Double-blind Period |
18.7; 18.5; 17.6 | 0.731 |
| SECONDARY Change in Percentage of Rescue-free Bowel Movements (RFBM) Classified as Diarrhea or Watery Stools From Baseline During Double-blind Period |
11.7; 8.8; 6.1 | 0.023 sig |
| SECONDARY Percentage of Patients With Any Diarrhea or Watery Rescue-free Bowel Movements (RFBM) During Open-label Period. |
50.1 | — |
| SECONDARY Change in Percentage of Rescue-free Bowel Movements (RFBM) With Straining Scale Scores of 0 or 1 (no, or Mild) From Baseline During Double-blind Period |
31.5; 31.1; 24.5 | 0.071 |
| SECONDARY Change in Percentage of Rescue-free Bowel Movements (RFBM) With a Sensation of Complete Evacuation From Baseline During Double-blind Period |
27.4; 24.2; 19.9 | 0.038 sig |
Summary
The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC).
Eligibility Criteria
Inclusion Criteria
- Adult outpatients with opioid-induced constipation and chronic non-malignant pain.
- Taking oral, transdermal, intravenous, or subcutaneous opioids.
- Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.
Exclusion Criteria
- History of chronic constipation before the initiation of opioid therapy.
- Other GI disorders known to affect bowel transit.
- Women who are pregnant, breast-feeding, or plan to become pregnant.
Data sourced from ClinicalTrials.gov (NCT00529087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.