Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00101998 |
Recruitment Status :
Completed
First Posted : January 19, 2005
Last Update Posted : August 30, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Constipation Bowel Dysfunction | Drug: alvimopan Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 233 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects |
Actual Study Start Date : | October 1, 2003 |
Actual Primary Completion Date : | May 1, 2006 |
Actual Study Completion Date : | May 1, 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: Alvimopan 0.5 mg Twice Daily (BID)
0.5 milligrams (mg) of alvimopan was administered orally BID for 3 weeks.
|
Drug: alvimopan |
Experimental: Alvimopan 1 mg Once Daily (QD)
0.5 mg of alvimopan was administered orally QD for 3 days, then 1 mg of alvimopan QD for the remaining 3 weeks. Placebo was administered orally QD to maintain the blind. A protocol amendment dropped this arm because another study had demonstrated 1 mg QD treatment to have similar efficacy but a less favorable gastrointestinal-related safety profile compared with 0.5 mg BID treatment. |
Drug: alvimopan Drug: placebo |
Experimental: Alvimopan 1 mg Twice Daily (BID)
0.5 mg of alvimopan was administered orally BID for 3 days, then 1 mg of alvimopan BID for the remaining 3 weeks.
|
Drug: alvimopan |
Placebo Comparator: Placebo
Placebo was administered orally BID for 3 weeks.
|
Drug: placebo |
- Change in weekly SCBM frequency. A SCBM is a spontaneous and complete bowel movement, which means a bowel movement that occurs with no laxative use in the prior 24 hours and leaves the subject with the feeling of complete evacuation of the rectum.
- Additional measures of Bowel movement (BM) frequency and symptoms, safety profile of the treatment regimens and any changes in pain intensity or opioid use.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Participant is in any stage of cancer but has a minimum life expectancy of at least 3 months at the time of the Screening Visit.
- Participant is taking opioid therapy for persistent cancer pain.
- Participant meets the definition of opioid-induced bowel dysfunction as follows: Since starting opioid therapy, the subject has had decreased bowel movement (BM) frequency and at least one of the following constipation symptoms [sensation of incomplete evacuation, difficulty in expelling stool (straining), hard stools (abnormal stool consistency)].
- Participant understands the procedures, agrees to participate in the study, and has signed and dated the informed consent form prior to the initiation of any study-related activities, including discontinuation of pre-study laxative regimen or other prohibited medications.
- Participant is able and willing to comply with a daily paper diary and is capable of completing paper questionnaires at study visits.
Exclusion criteria:
- Participant is pregnant or lactating, or planning to become pregnant.
- Participant is not ambulatory.
- Participant has participated in another trial with an investigational drug (unapproved), device or procedure within 30 days of the Screening Visit.
- Participant is unable to eat, drink, take/hold down oral medications.
- Participant is taking opioids for the management of drug addiction.
- Participant is unable or unwilling to discontinue the use of and/or refrain from using laxatives of all types and formulation at the Screening Visit and throughout the entire study.
- Participant has severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation. This would include a subject who has reported no bowel movement for 7 consecutive days prior to the Screening Visit.
- Participant with gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.
- Participant is currently taking vinca alkyloids or plans to take vinca alkyloids during the study.
- Participant is currently undergoing abdominal radiation therapy and/or plans to undergo abdominal radiation therapy during the study.
- Participant is human immunodeficiency virus (HIV)-infected, has active hepatitis (any subtype including ongoing chronic hepatitis B), or has ever been infected with hepatitis C.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00101998

Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | Cubist Pharmaceuticals LLC |
ClinicalTrials.gov Identifier: | NCT00101998 |
Obsolete Identifiers: | NCT00903513 |
Other Study ID Numbers: |
3753-009 767905/008 ( Other Identifier: Cubist Study Number ) |
First Posted: | January 19, 2005 Key Record Dates |
Last Update Posted: | August 30, 2017 |
Last Verified: | August 2017 |
OBD (Induced Bowel Dysfunction) cancer pain pain medication |
constipation bowel bowel dysfunction |
Intestinal Diseases Gastrointestinal Diseases Constipation Signs and Symptoms, Digestive |
Digestive System Diseases Alvimopan Gastrointestinal Agents |