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

ID: NCT00135577
Status: Completed
Phase: Phase 2
Start Date: September 01, 2004
First Submitted: August 24, 2005
Last Updated: September 01, 2015
Results: N/A
Sponsors & Collaborators: Cubist Pharmaceuticals LLC, GlaxoSmithKline
Location: Canada, Finland, France, Hong Kong, New Zealand, Pakistan, Peru, Poland, Portugal, Russian Federation, Spain, United Kingdom, United States
Conditions: Cancer, Bowel Dysfunction
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Study Description

Brief Summary

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Bowel Dysfunction

Cancer

Drug: alvimopan
Other Names
Drug: placebo
Other Names
Phase 2

Tracking Information

First Submitted DateAugust 24, 2005
Last Update Posted DateSeptember 01, 2015
Start DateSeptember 01, 2004
Actual Completion DateApril 01, 2007
Primary Completion DateApril 01, 2007
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Incidence of reported adverse events, including serious adverse events

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

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

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleStudy 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects
Official TitleA 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
Brief Summary

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.

Detailed Description

Study TypeInterventional
Study PhasePhase 2
Estimated Enrollment
67
Allocation
Non-Randomized
Interventional Model
Parallel Assignment
Masking
Double
Primary Purpose
Treatment
Conditions
Bowel Dysfunction
Cancer
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: alvimopan

Other Names
Drug: placebo

Other Names
Study Groups/Cohorts
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.

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.

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.

Placebo
Placebo was administered orally once in the morning and once in evening.

Study Arms
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

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

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 : 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

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

Arm Intervention/Treatment
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
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
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 : 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
Placebo Comparator Placebo
Placebo was administered orally once in the morning and once in evening.
Drug : placebo

Recruitment Information

Recruitment Status:Completed
Enrollment67
Completion DateApril 01, 2007
Eligibility 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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Canada
Finland
France
Hong Kong
New Zealand
Pakistan
Peru
Poland
Portugal
Russian Federation
Spain
United Kingdom
United States
Argentina
Czech Republic
India
Korea, Republic of
Philippines

Administrative Information

NCT Number:NCT00135577
Other Study ID Numbers
ABD101684
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Cubist Pharmaceuticals LLC
Collaborators
GlaxoSmithKline
Investigators
Study Director
GSK Clinical Trials, MD
GlaxoSmithKline