Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00135577
First received: August 24, 2005
Last updated: March 6, 2009
Last verified: March 2009
  Purpose

ABD101684 serves as an extension to Study SB-767905/008 and offers continued access to blinded investigational product to subjects who have completed the original study.


Condition Intervention Phase
Cancer
Bowel Dysfunction
Drug: alvimopan
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Multicenter Phase IIb Extension Study to Evaluate the Safety and Efficacy 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:

Primary Outcome Measures:
  • Incidence of reported adverse events, including serious adverse events

Secondary Outcome Measures:
  • Incidence of treatment-limiting toxicities, changes in pain intensity, patient satisfaction, health outcome measures

Estimated Enrollment: 100
Study Start Date: September 2004
Intervention Details:
    Drug: alvimopan
    Other Name: alvimopan
  Eligibility

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

Inclusion Criteria:

  • Completed GSK sponsored alvimopan (opioid-induced bowel dysfunction) OBD study for subjects with cancer-related pain, e.g. SB-767905/008.
  • Taking full agonist opioid therapy for cancer related pain.
  • Met entry criteria of OBD in original study and per investigator continues to require therapy for management of OBD.
  • Capable of completing paper questionnaires at the study visits.

Exclusion Criteria:

  • Unable to eat or drink.
  • Taking opioids for management of drug addiction.
  • Unable to use only rescue laxatives provided.
  • Inappropriately managed severe constipation that puts subject at risk of complications.
  • Has gastrointestinal (GI) or pelvic disorder known to affect bowel transit.
  • Concomitant medication(s), medical condition, or clinically significant laboratory abnormality that could jeopardize subject and also contraindicate study participation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135577

  Show 40 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: NCT00135577     History of Changes
Other Study ID Numbers: ABD101684
Study First Received: August 24, 2005
Last Updated: March 6, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals:
opioids
constipation
opioid-induced bowel dysfunction

Additional relevant MeSH terms:
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 15, 2014