Clinical Evaluation Of Alvimopan (SB767905) On Constipation And Related Symptoms Associated With Opioid - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00331045

Purpose

This study is intended to investigate the recommended dose of alvimopan in doses 0.25mg/day (0.25mg, OD), 0.5mg/day (0.25mg, BID) or 1mg/day (0.5mg, BID) or placebo for 3 weeks in patients who receive opioids for the management of cancer pain and develop constipation, by giving overall consideration to the efficacy and safety data in each treatment group. Also, efficacy and safety data of alvimopan in the recommended dose group will be compared with those of placebo and to confirm alvimopan's safety and efficacy.

Condition	Intervention	Phase
Cancer Constipation	Drug: SB767905	Phase II

MedlinePlus related topics: Cancer Constipation

Drug Information available for: Alvimopan LY246736

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Evaluation of Alvimopan (SB767905) on Constipation and Related Symptoms Associated With Opioid -A Placebo-Controlled Double-Blind Study in Cancer Patients-

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change from baseline during the 1-week Pre-Treatment Period in average weekly bowel movement with no rescue laxative use in the previous 24 hours Frequency during the 3-week Treatment Period

Secondary Outcome Measures:

Proportion of responders for OBD global improvement Changes in weekly subjective bowel movement symptoms Changes in weekly constipation symptoms questionnaire

Estimated Enrollment:	280
Study Start Date:	April 2006

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Have cancer.
Taking opioid therapy for continued intractable pain.
Experiencing less bowel movement frequency compared to that before the opioid treatment.
Must meet the protocol-definition of opioid-induced constipation.

Exclusion criteria:

Gastrointestinal or pelvic disorders known to affect gastrointestinal functions or induce bowel transit disorder and ileus.
Subjects, who in the investigator's opinion, have gastrointestinal dysfunction predominantly due to causes other than the use of opioids.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331045

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	ABD102965
Study First Received:	May 26, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00331045
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

Opioids
cancer
constipation

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Constipation

ClinicalTrials.gov processed this record on January 15, 2009