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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Cubist Pharmaceuticals Holdings LLC
ClinicalTrials.gov Identifier:
NCT00101998
First received: January 18, 2005
Last updated: September 1, 2015
Last verified: September 2009
  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
Drug: placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals Holdings LLC:

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.

Enrollment: 233
Study Start Date: October 2003
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

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

  Show 162 Study Locations
Sponsors and Collaborators
Cubist Pharmaceuticals Holdings LLC
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cubist Pharmaceuticals Holdings LLC
ClinicalTrials.gov Identifier: NCT00101998     History of Changes
Obsolete Identifiers: NCT00903513
Other Study ID Numbers: 767905/008
Study First Received: January 18, 2005
Last Updated: September 1, 2015
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 Holdings LLC:
OBD (Induced Bowel Dysfunction)
cancer pain
pain medication
constipation
bowel
bowel dysfunction

Additional relevant MeSH terms:
Constipation
Gastrointestinal Diseases
Intestinal Diseases
Digestive System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Alvimopan
Analgesics
Central Nervous System Agents
Gastrointestinal Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 03, 2015