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

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 Phase III

MedlinePlus related topics:

Cancer Constipation

ChemIDplus related topics:

Alvimopan LY246736

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, 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:	March 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

Locations


Japan
	GSK Clinical Trials Call Center
	Meguro-ku, Japan, 152
	GSK Clinical Trials Call Center
	Osaka, Japan, 534
	GSK Clinical Trials Call Center
	Sapporo, Japan, 003
	GSK Clinical Trials Call Center
	Kawaguchi, Japan, 333
	GSK Clinical Trials Call Center
	Nagoya, Japan, 460
	GSK Clinical Trials Call Center
	Kyoto, Japan, 602
	GSK Clinical Trials Call Center
	Hiroshima, Japan, 734
	GSK Clinical Trials Call Center
	Nagoya, Japan, 464
	GSK Clinical Trials Call Center
	Kamakura, Japan, 248
	GSK Clinical Trials Call Center
	Kumamoto, Japan, 861
	GSK Clinical Trials Call Center
	Kobe, Japan, 650
	GSK Clinical Trials Call Center
	Nishinomiya, Japan, 662
	GSK Clinical Trials Call Center
	Sapporo, Japan, 060
	GSK Clinical Trials Call Center
	Hiroshima, Japan, 730
	GSK Clinical Trials Call Center
	Sapporo, Japan, 065
	GSK Clinical Trials Call Center
	Nagoya, Japan, 457
	GSK Clinical Trials Call Center
	Sakai, Japan, 591
	GSK Clinical Trials Call Center
	Akashi, Japan, 673
	GSK Clinical Trials Call Center
	Utsunomiya, Japan, 320
	GSK Clinical Trials Call Center
	Shizuoka, Japan, 420
	GSK Clinical Trials Call Center
	Osakasayama, Japan, 589
	GSK Clinical Trials Call Center
	Ota, Japan, 373
	GSK Clinical Trials Call Center
	Hashimoto, Japan, 648
	GSK Clinical Trials Call Center
	Yabu, Japan, 667
	GSK Clinical Trials Call Center
	Yufu, Japan, 879
	GSK Clinical Trials Call Center
	Saga, Japan, 849
	GSK Clinical Trials Call Center
	Sendai, Japan, 980
	GSK Clinical Trials Call Center
	Kure, Japan, 737
	GSK Clinical Trials Call Center
	Kodaira, Japan, 187
	GSK Clinical Trials Call Center
	Shibuya-ku, Japan, 150

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trial, MD	GlaxoSmithKline

More Information

Study ID Numbers:	ABD102965
First Received:	May 26, 2006
Last Updated:	January 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 October 03, 2008

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