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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:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00135577
First received: August 24, 2005
Last updated: March 6, 2009
Last verified: March 2009
History of Changes

August 24, 2005
March 6, 2009
September 2004
Not Provided
Incidence of reported adverse events, including serious adverse events
Same as current
Complete list of historical versions of study NCT00135577 on ClinicalTrials.gov Archive Site
Incidence of treatment-limiting toxicities, changes in pain intensity, patient satisfaction, health outcome measures
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Cancer
  • Bowel Dysfunction
Drug: alvimopan
Other Name: alvimopan
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Finland,   France,   Hong Kong,   New Zealand,   Pakistan,   Peru,   Poland,   Portugal,   Russian Federation,   Spain,   United Kingdom
 
NCT00135577
ABD101684
Not Provided
Study Director, GSK
Cubist Pharmaceuticals
GlaxoSmithKline
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
Cubist Pharmaceuticals
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP