Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects
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
1 other identifier
interventional
67
13 countries
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 cancer
Started Sep 2004
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 24, 2005
CompletedFirst Posted
Study publicly available on registry
August 26, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedSeptember 2, 2015
September 1, 2009
2.6 years
August 24, 2005
September 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of reported adverse events, including serious adverse events
Secondary Outcomes (1)
Incidence of treatment-limiting toxicities, changes in pain intensity, patient satisfaction, health outcome measures
Study Arms (4)
Alvimopan 0.5 mg Twice Daily (BID)
EXPERIMENTAL0.5 milligrams (mg) of alvimopan was administered orally once in the morning and once in the evening.
Alvimopan 1 mg Once Daily (QD)
EXPERIMENTALParticipants 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)
EXPERIMENTALParticipants 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 COMPARATORPlacebo was administered orally once in the morning and once in evening.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
GSK Investigational Site
Duarte, California, 91010, United States
GSK Investigational Site
Fountain Valley, California, 92708, United States
GSK Investigational Site
La Verne, California, 91750, United States
GSK Investigational Site
Sacramento, California, 95819, United States
GSK Investigational Site
San Diego, California, 92103, United States
GSK Investigational Site
New Port Richey, Florida, 34652, United States
GSK Investigational Site
Tampa, Florida, 33612-9497, United States
GSK Investigational Site
West Des Moines, Iowa, 50265, United States
GSK Investigational Site
Boston, Massachusetts, 02215, United States
GSK Investigational Site
Worcester, Massachusetts, 01608, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Durham, North Carolina, 27710, United States
GSK Investigational Site
Hendersonville, North Carolina, 28793, United States
GSK Investigational Site
Tacoma, Washington, 98405, United States
GSK Investigational Site
Winnipeg, Manitoba, R3A 1R9, Canada
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
GSK Investigational Site
Greater Sudbury, Ontario, P3E 5J1, Canada
GSK Investigational Site
Kitchener, Ontario, N2G 1G3, Canada
GSK Investigational Site
Bonaventure, Quebec, G0C 1E0, Canada
GSK Investigational Site
Chandler, Quebec, G0C 1K0, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1, Canada
GSK Investigational Site
Helsinki, 00029, Finland
GSK Investigational Site
Bordeaux, 33076, France
GSK Investigational Site
Strasbourg, 67000, France
GSK Investigational Site
Vandœuvre-lès-Nancy, 54511, France
GSK Investigational Site
Villejuif, 94805, France
GSK Investigational Site
Kwun Tong, Hong Kong
GSK Investigational Site
Wellington, 6002, New Zealand
GSK Investigational Site
Lahore, 54600, Pakistan
GSK Investigational Site
Lima, Lima Province, Lima 34, Peru
GSK Investigational Site
Bialystok, 15-540, Poland
GSK Investigational Site
Lublin, 20-090, Poland
GSK Investigational Site
Olsztyn, 10-228, Poland
GSK Investigational Site
Otwock, 05-400, Poland
GSK Investigational Site
Poznan, 60-569, Poland
GSK Investigational Site
Lisbon, 1070, Portugal
GSK Investigational Site
Lisbon, 1800, Portugal
GSK Investigational Site
Moscow, 117216, Russia
GSK Investigational Site
Alcorcón, 28922, Spain
GSK Investigational Site
Nottingham, NG5 1PB, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, MD
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2005
First Posted
August 26, 2005
Study Start
September 1, 2004
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
September 2, 2015
Record last verified: 2009-09