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

Information source: Cubist Pharmaceuticals Holdings LLC
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer; Bowel Dysfunction

Intervention: alvimopan (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Cubist Pharmaceuticals Holdings LLC

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Incidence of reported adverse events, including serious adverse events

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

GSK Investigational Site, Helsinki 00029, Finland

GSK Investigational Site, Bordeaux Cedex 33076, France

GSK Investigational Site, Strasbourg 67000, France

GSK Investigational Site, Vandoeuvre-Les-Nancy 54511, France

GSK Investigational Site, Villejuif Cedex 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 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, Lisboa 1070, Portugal

GSK Investigational Site, Lisboa 1800, Portugal

GSK Investigational Site, Moscow 117216, Russian Federation

GSK Investigational Site, Alcorcon 28922, Spain

GSK Investigational Site, Nottingham NG5 1PB, United Kingdom

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, Winnipeg, Manitoba R3A 1R9, Canada

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, Saint John's, Newfoundland and Labrador A1B 3V6, Canada

GSK Investigational Site, Durham, North Carolina 27710, United States

GSK Investigational Site, Hendersonville, North Carolina 28793, United States

GSK Investigational Site, Kitchener, Ontario N2G 1G3, Canada

GSK Investigational Site, Sudbury, Ontario P3E 5J1, 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, Tacoma, Washington 98405, United States

Additional Information

Starting date: September 2004
Last updated: March 6, 2009

Page last updated: August 20, 2015

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