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Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
This study has been completed.
Sponsor:
Cubist Pharmaceuticals LLC
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT00256932
First received: November 21, 2005
Last updated: September 1, 2015
Last verified: December 2011
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Purpose
Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.
| Condition | Intervention | Phase |
|---|---|---|
| Bowel Dysfunction Constipation | Drug: alvimopan Drug: Placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Alvimopan 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain |
Resource links provided by NLM:
MedlinePlus related topics:
Constipation
Drug Information available for:
Alvimopan
U.S. FDA Resources
Further study details as provided by Cubist Pharmaceuticals LLC:
Primary Outcome Measures:
- to compare alvimopan with placebo for efficacy in the treatment of OBD
Secondary Outcome Measures:
- Safety and tolerability, quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data)
| Enrollment: | 518 |
| Study Start Date: | August 2005 |
| Study Completion Date: | May 2006 |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo | Drug: Placebo |
| Experimental: Alvimopan 0.5 mg once daily |
Drug: alvimopan
0.5 mg
Other Name: Entereg
|
| Experimental: alvimopan 0.5 mg twice daily |
Drug: alvimopan
0.5 mg
Other Name: Entereg
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Has consented to participate in this study.
- Taking opioid therapy for persistent non-cancer pain.
- Has bowel dysfunction mainly due to opioids.
- Has bowel dysfunction since starting opioids as defined by infrequent bowel movements and additional bowel-related symptoms.
- Willing to discontinue laxative therapy (will be provided study-specific standardized laxative if needed).
- Willing to report daily bowel symptoms.
Exclusion criteria:
- Pregnant, lactating, or planning to become pregnant.
- Not ambulatory.
- Participated in another trial with an investigational drug in the past 30 days.
- Taking opioids for the management of drug addiction or cancer-related pain.
- Severe constipation whereby the subject is at immediate risk of developing serious complications of constipation.
- Gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.
- HIV-infected, has active hepatitis, or has ever been infected with hepatitis C.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256932
Show 200 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256932
Show 200 Study Locations
Sponsors and Collaborators
Cubist Pharmaceuticals LLC
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
Publications:
| Responsible Party: | Cubist Pharmaceuticals LLC |
| ClinicalTrials.gov Identifier: | NCT00256932 History of Changes |
| Other Study ID Numbers: |
SB-767905/012 |
| Study First Received: | November 21, 2005 |
| Last Updated: | September 1, 2015 |
Keywords provided by Cubist Pharmaceuticals LLC:
|
bowel dysfunction constipation gastrointestinal opioids |
pain non-cancer pain Opioid-induced |
Additional relevant MeSH terms:
|
Constipation Intestinal Diseases Gastrointestinal Diseases Signs and Symptoms, Digestive Signs and Symptoms Digestive System Diseases Analgesics, Opioid Alvimopan |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on August 22, 2017