Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication

Study Description

Brief Summary

Detailed Description

Condition or disease	Intervention/treatment	Phase
Bowel Dysfunction Constipation	Drug: alvimopan Other Names Drug: placebo Other Names	Phase 2

Tracking Information

First Submitted Date	January 18, 2005
Last Update Posted Date	August 29, 2017
Actual Start Date	October 01, 2003
Actual Completion Date	May 01, 2006
Actual Primary Completion Date	May 01, 2006
Results First Submitted Date	N/A
Received Results Disposit Date	N/A

Current Primary Outcome Measures

• 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.

Original Primary Outcome Measures

Current Secondary Outcome Measures

• Additional measures of Bowel movement (BM) frequency and symptoms, safety profile of the treatment regimens and any changes in pain intensity or opioid use.

Original Secondary Outcome Measures

Study Design

Brief Title	Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication
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
Brief Summary	A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain. The study will require five visits over a five-week period.
Detailed Description
Study Type	Interventional
Study Phase	Phase 2
Estimated Enrollment	233
Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Double
Primary Purpose	Treatment
Conditions	Bowel Dysfunction Constipation
Target Follow-Up Duration	N/A
Biospecimen:	N/A
Sampling Method	N/A
Study Population	N/A
Intervention	Drug: alvimopan Other Names Drug: placebo Other Names
Study Groups/Cohorts	Alvimopan 0.5 mg Twice Daily (BID) 0.5 milligrams (mg) of alvimopan was administered orally BID for 3 weeks. 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. 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. Placebo Placebo was administered orally BID for 3 weeks.
Study Arms	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 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 : 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

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
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 : 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

Recruitment Information

Recruitment Status:	Completed
Enrollment	233
Completion Date	May 01, 2006
Eligibility Criteria:	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.
Gender	All
Age	18 Years to N/A
Accepts Healthy Volunteers	No
Contacts	Not Available
Listed Location Countries	Argentina Australia Canada Czechia Finland France Germany Hong Kong Hungary India Italy Korea, Republic of Netherlands New Zealand Pakistan Peru Philippines Poland Portugal Russian Federation South Africa Spain Taiwan Thailand United Kingdom United States Brazil Czech Republic Greece Ireland

Administrative Information

NCT Number:	NCT00101998
Other Study ID Numbers	3753-009 767905/008 NCT00903513
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement	Not Available
Responsible Party	,
Study Sponsor	Cubist Pharmaceuticals LLC
Collaborators	GlaxoSmithKline
Investigators	Study Director GSK Clinical Trials, MD GlaxoSmithKline