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

Purpose

Study SB-767905/008 was a multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in participants with cancer pain.

Study ABD101684 will serve as an extension to Study SB-767905/008 and offer continued access to blinded investigational product to participants who have completed the original study. The purpose of Study ABD101684 is to evaluate the safety and efficacy of alvimopan compared to placebo in subjects who completed Study SB-767905/008 and elected to participate in this extension study.

Condition	Intervention	Phase
Cancer Bowel Dysfunction	Drug: alvimopan Drug: placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Alvimopan

U.S. FDA Resources

Further study details as provided by Cubist Pharmaceuticals LLC:

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


Enrollment:	67
Study Start Date:	September 2004
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Alvimopan 0.5 mg Twice Daily (BID) 0.5 milligrams (mg) of alvimopan was administered orally once in the morning and once in the evening.	Drug: alvimopan
Experimental: Alvimopan 1 mg Once Daily (QD) Participants who did not have an interruption in blinded investigational product between the original study and the extension study received Alvimopan 1 mg in the morning and received placebo in the evening. Participants who had an interruption in blinded investigational product between studies received 0.5 mg of alvimopan in the morning and placebo in the evening for 3 days, then 1 mg of alvimopan in the morning and placebo in the evening for the remaining 3 weeks.	Drug: alvimopan Drug: placebo
Experimental: Alvimopan 1 mg Twice Daily (BID) Participants who did not have an interruption in blinded investigational product between the original study and the extension study received Alvimopan 1 mg once in the morning and once in the evening. Participants who had an interruption in blinded investigational product between studies received 0.5 mg of alvimopan once in the morning and once in the evening for 3 days, then 1 mg of alvimopan once in the morning and once in the evening.	Drug: alvimopan
Placebo Comparator: Placebo Placebo was administered orally once in the morning and once in evening.	Drug: placebo

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Show 40 Study Locations

Sponsors and Collaborators

Cubist Pharmaceuticals LLC

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information


Responsible Party:	Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier:	NCT00135577 History of Changes
Other Study ID Numbers:	ABD101684
Study First Received:	August 24, 2005
Last Updated:	September 1, 2015

Keywords provided by Cubist Pharmaceuticals LLC:


opioids constipation opioid-induced bowel dysfunction

Additional relevant MeSH terms:


Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Analgesics, Opioid Alvimopan Narcotics	Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 23, 2017