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 (Responsible Party):
Cubist Pharmaceuticals Holdings LLC
ClinicalTrials.gov Identifier:
NCT00135577
First received: August 24, 2005
Last updated: September 1, 2015
Last verified: September 2009
  Purpose

Study SB-767905/008 was 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 participants with cancer pain.

Study ABD101684 will serve as an extension to Study SB-767905/008 and offer continued access to blinded investigational product to participants who have completed the original study. The purpose of Study ABD101684 is to evaluate the safety and efficacy of alvimopan compared to placebo in subjects who completed Study SB-767905/008 and elected to participate in this extension study.


Condition Intervention Phase
Cancer
Bowel Dysfunction
Drug: alvimopan
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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 Holdings LLC:

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

Enrollment: 67
Study Start Date: September 2004
Study Completion Date: April 2007
Primary Completion Date: April 2007 (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 once in the morning and once in the evening.
Drug: alvimopan
Other Name: alvimopan
Experimental: Alvimopan 1 mg Once Daily (QD)

Participants who did not have an interruption in blinded investigational product between the original study and the extension study received Alvimopan 1 mg in the morning and received placebo in the evening.

Participants who had an interruption in blinded investigational product between studies received 0.5 mg of alvimopan in the morning and placebo in the evening for 3 days, then 1 mg of alvimopan in the morning and placebo in the evening for the remaining 3 weeks.

Drug: alvimopan
Other Name: alvimopan
Drug: placebo
Experimental: Alvimopan 1 mg Twice Daily (BID)

Participants who did not have an interruption in blinded investigational product between the original study and the extension study received Alvimopan 1 mg once in the morning and once in the evening.

Participants who had an interruption in blinded investigational product between studies received 0.5 mg of alvimopan once in the morning and once in the evening for 3 days, then 1 mg of alvimopan once in the morning and once in the evening.

Drug: alvimopan
Other Name: alvimopan
Placebo Comparator: Placebo
Placebo was administered orally once in the morning and once in evening.
Drug: placebo

  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
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: NCT00135577

  Show 40 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: NCT00135577     History of Changes
Other Study ID Numbers: ABD101684
Study First Received: August 24, 2005
Last Updated: September 1, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Gastrointestinal Diseases
Intestinal Diseases
Digestive System Diseases
Alvimopan
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 02, 2015