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

• ClinicalTrials.gov Identifier: NCT00135577
• Recruitment Status: Completed
• First Posted: August 26, 2005
• Last Update Posted: September 2, 2015
• Sponsor: Cubist Pharmaceuticals LLC
• Collaborator: GlaxoSmithKline
• Information provided by (Responsible Party): Cubist Pharmaceuticals LLC

Study Description

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

• 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

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

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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

Locations

United States, California

GSK Investigational Site

Duarte, California, United States, 91010

GSK Investigational Site

Fountain Valley, California, United States, 92708

GSK Investigational Site

La Verne, California, United States, 91750

GSK Investigational Site

Sacramento, California, United States, 95819

GSK Investigational Site

San Diego, California, United States, 92103

United States, Florida

GSK Investigational Site

New Port Richey, Florida, United States, 34652

GSK Investigational Site

Tampa, Florida, United States, 33612-9497

United States, Iowa

GSK Investigational Site

West Des Moines, Iowa, United States, 50265

United States, Massachusetts

GSK Investigational Site

Boston, Massachusetts, United States, 02215

GSK Investigational Site

Worcester, Massachusetts, United States, 01608

United States, Missouri

GSK Investigational Site

St. Louis, Missouri, United States, 63141

United States, North Carolina

GSK Investigational Site

Durham, North Carolina, United States, 27710

GSK Investigational Site

Hendersonville, North Carolina, United States, 28793

United States, Washington

GSK Investigational Site

Tacoma, Washington, United States, 98405

Canada, Manitoba

GSK Investigational Site

Winnipeg, Manitoba, Canada, R3A 1R9

Canada, Newfoundland and Labrador

GSK Investigational Site

Saint John's, Newfoundland and Labrador, Canada, A1B 3V6

Canada, Ontario

GSK Investigational Site

Kitchener, Ontario, Canada, N2G 1G3

GSK Investigational Site

Sudbury, Ontario, Canada, P3E 5J1

Canada, Quebec

GSK Investigational Site

Bonaventure, Quebec, Canada, G0C 1E0

GSK Investigational Site

Chandler, Quebec, Canada, G0C 1K0

GSK Investigational Site

Sherbrooke, Quebec, Canada, J1H 1Z1

Finland

GSK Investigational Site

Helsinki, Finland, 00029

France

GSK Investigational Site

Bordeaux Cedex, France, 33076

GSK Investigational Site

Strasbourg, France, 67000

GSK Investigational Site

Vandoeuvre-Les-Nancy, France, 54511

GSK Investigational Site

Villejuif Cedex, France, 94805

Hong Kong

GSK Investigational Site

Kwun Tong, Hong Kong

New Zealand

GSK Investigational Site

Wellington, New Zealand, 6002

Pakistan

GSK Investigational Site

Lahore, Pakistan, 54600

Peru

GSK Investigational Site

Lima, Peru, Lima 34

Poland

GSK Investigational Site

Bialystok, Poland, 15-540

GSK Investigational Site

Lublin, Poland, 20-090

GSK Investigational Site

Olsztyn, Poland, 10-228

GSK Investigational Site

Otwock, Poland, 05-400

GSK Investigational Site

Poznan, Poland, 60-569

Portugal

GSK Investigational Site

Lisboa, Portugal, 1070

GSK Investigational Site

Lisboa, Portugal, 1800

Russian Federation

GSK Investigational Site

Moscow, Russian Federation, 117216

Spain

GSK Investigational Site

Alcorcon, Spain, 28922

United Kingdom

GSK Investigational Site

Nottingham, United Kingdom, NG5 1PB

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
• 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:

Intestinal Diseases; Gastrointestinal Diseases; Cancer Pain; Pain; Neurologic Manifestations; Digestive System Diseases; Alvimopan; Gastrointestinal Agents