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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00101998
First Posted: January 19, 2005
Last Update Posted: August 30, 2017
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.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC
  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
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

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals 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
Actual Study Start Date: October 1, 2003
Study Completion Date: May 1, 2006
Primary Completion Date: May 1, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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

Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00101998     History of Changes
Obsolete Identifiers: NCT00903513
Other Study ID Numbers: 3753-009
767905/008 ( Other Identifier: Cubist Study Number )
First Submitted: January 18, 2005
First Posted: January 19, 2005
Last Update Posted: August 30, 2017
Last Verified: August 2017

Keywords provided by Cubist Pharmaceuticals LLC:
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
Alvimopan
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents