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

This study has been completed.

First Received: August 24, 2005 Last Updated: March 6, 2009 History of Changes

Sponsors and Collaborators:	Adolor Corporation GlaxoSmithKline
Information provided by:	Adolor Corporation
ClinicalTrials.gov Identifier:	NCT00135577

Purpose

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.

Condition	Intervention	Phase
Cancer Bowel Dysfunction	Drug: alvimopan	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: LY246736 Alvimopan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study
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

Further study details as provided by Adolor Corporation:

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

Estimated Enrollment:	100
Study Start Date:	September 2004

Eligibility

Ages Eligible for Study:	18 Years and older
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135577

Show 40 Study Locations

Sponsors and Collaborators

Adolor Corporation

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	ABD101684
Study First Received:	August 24, 2005
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00135577 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Food and Drug Administration

Keywords provided by Adolor Corporation:

opioids
constipation
opioid-induced bowel dysfunction

Study placed in the following topic categories:

Constipation
Central Nervous System Depressants
Pain

Peripheral Nervous System Agents
Analgesics
Analgesics, Opioid

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Peripheral Nervous System Agents

Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 07, 2009