Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication - Full Text View

Purpose

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.

Condition	Intervention	Phase
Constipation Bowel Dysfunction	Drug: alvimopan	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement Cancer Constipation

Drug Information available for: Alvimopan

U.S. FDA Resources

Further study details as provided by Cubist Pharmaceuticals:

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.

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.

Estimated Enrollment:	215
Study Start Date:	October 2003

Intervention Details:

Other Name: alvimopan

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Subject is in any stage of cancer but has a minimum life expectancy of at least 3 months at the time of the Screening Visit.
Subject is taking opioid therapy for persistent cancer pain.
Subject meets the definition of opioid-induced bowel dysfunction as follows: Since starting opioid therapy, the subject has had decreased 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)].
Subject 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.
Subject is able and willing to comply with a daily paper diary and is capable of completing paper questionnaires at study visits.

Exclusion criteria:

Subject is pregnant or lactating, or planning to become pregnant.
Subject is not ambulatory.
Subject has participated in another trial with an investigational drug (unapproved), device or procedure within 30 days of the Screening Visit.
Subject is unable to eat, drink, take/hold down oral medications.
Subject is taking opioids for the management of drug addiction.
Subject 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.
Subject 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.
Subject with gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.
Subject is currently taking vinca alkyloids or plans to take vinca alkyloids during the study.
Subject is currently undergoing abdominal radiation therapy and/or plans to undergo abdominal radiation therapy during the study.
Subject is HIV-infected, has active hepatitis (any subtype including ongoing chronic hepatitis B), or has ever been infected with hepatitis C.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00101998

Show 162 Study Locations

Sponsors and Collaborators

Cubist Pharmaceuticals

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00101998 History of Changes
Obsolete Identifiers:	NCT00903513
Other Study ID Numbers:	767905/008
Study First Received:	January 18, 2005
Last Updated:	March 6, 2009
Health Authority:	United States: Food and Drug Administration France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Cubist Pharmaceuticals:

OBD (Induced Bowel Dysfunction)
cancer pain
pain medication

constipation
bowel
bowel dysfunction

Additional relevant MeSH terms:

Constipation
Intestinal Diseases
Gastrointestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Digestive System Diseases
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013