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 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 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
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 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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

  Hide Study Locations
Locations
United States, California
GSK Investigational Site
Duarte, California, United States, 91010
GSK Investigational Site
Fountain Valley, California, United States, 92708
GSK Investigational Site
La Verne, California, United States, 91750
GSK Investigational Site
Sacramento, California, United States, 95819
GSK Investigational Site
San Diego, California, United States, 92103
United States, Florida
GSK Investigational Site
New Port Richey, Florida, United States, 34652
GSK Investigational Site
Tampa, Florida, United States, 33612-9497
United States, Iowa
GSK Investigational Site
West Des Moines, Iowa, United States, 50265
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02215
GSK Investigational Site
Worcester, Massachusetts, United States, 01608
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63141
United States, North Carolina
GSK Investigational Site
Durham, North Carolina, United States, 27710
GSK Investigational Site
Hendersonville, North Carolina, United States, 28793
United States, Washington
GSK Investigational Site
Tacoma, Washington, United States, 98405
Canada, Manitoba
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Newfoundland and Labrador
GSK Investigational Site
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
GSK Investigational Site
Kitchener, Ontario, Canada, N2G 1G3
GSK Investigational Site
Sudbury, Ontario, Canada, P3E 5J1
Canada, Quebec
GSK Investigational Site
Bonaventure, Quebec, Canada, G0C 1E0
GSK Investigational Site
Chandler, Quebec, Canada, G0C 1K0
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 1Z1
Finland
GSK Investigational Site
Helsinki, Finland, 00029
France
GSK Investigational Site
Bordeaux Cedex, France, 33076
GSK Investigational Site
Strasbourg, France, 67000
GSK Investigational Site
Vandoeuvre-Les-Nancy, France, 54511
GSK Investigational Site
Villejuif Cedex, France, 94805
Hong Kong
GSK Investigational Site
Kwun Tong, Hong Kong
New Zealand
GSK Investigational Site
Wellington, New Zealand, 6002
Pakistan
GSK Investigational Site
Lahore, Pakistan, 54600
Peru
GSK Investigational Site
Lima, Peru, Lima 34
Poland
GSK Investigational Site
Bialystok, Poland, 15-540
GSK Investigational Site
Lublin, Poland, 20-090
GSK Investigational Site
Olsztyn, Poland, 10-228
GSK Investigational Site
Otwock, Poland, 05-400
GSK Investigational Site
Poznan, Poland, 60-569
Portugal
GSK Investigational Site
Lisboa, Portugal, 1070
GSK Investigational Site
Lisboa, Portugal, 1800
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 117216
Spain
GSK Investigational Site
Alcorcon, Spain, 28922
United Kingdom
GSK Investigational Site
Nottingham, United Kingdom, NG5 1PB
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: 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 LLC:
opioids
constipation
opioid-induced bowel dysfunction

Additional relevant MeSH terms:
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Analgesics, Opioid
Alvimopan
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 21, 2016