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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer, Bowel Dysfunction

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence of reported adverse events, including serious adverse events

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

ABD101684

NCT ID:

NCT00135577

Start Date:

September 2004

Completion Date:

Related Keywords:

  • Cancer
  • Bowel Dysfunction
  • opioids
  • constipation
  • opioid-induced bowel dysfunction
  • Intestinal Diseases
  • Gastrointestinal Diseases

Name

Location

GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteSpringfield, Massachusetts  01107
GSK Investigational SiteSt. Louis, Missouri  63141
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteBettendorf, Iowa  52722
GSK Investigational SiteSeattle, Washington  98133