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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Cancer; Bowel Dysfunction	Drug: alvimopan; Drug: placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	67 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (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
Study Start Date :	September 2004
Actual Primary Completion Date :	April 2007
Actual Study Completion Date :	April 2007

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Incidence of reported adverse events, including serious adverse events

Secondary Outcome Measures :

1. Incidence of treatment-limiting toxicities, changes in pain intensity, patient satisfaction, health outcome measures

Eligibility Criteria

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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

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  Show 40 Study Locations

Sponsors and Collaborators

Cubist Pharmaceuticals LLC

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier:	NCT00135577 History of Changes
Other Study ID Numbers:	ABD101684
First Posted:	August 26, 2005
Last Update Posted:	September 2, 2015
Last Verified:	September 2009

Keywords provided by Cubist Pharmaceuticals LLC:

opioids; constipation; opioid-induced bowel dysfunction

Additional relevant MeSH terms:

Cancer Pain; Intestinal Diseases; Gastrointestinal Diseases; Pain; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; 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