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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00135577
• Other study ID #: ABD101684
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2005
• Last updated: September 1, 2015
• Start date: September 2004
• Est. completion date: April 2007

Study information

• Verified date: September 2009
• Source: Cubist Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bowel Dysfunction
• Cancer
• Gastrointestinal Diseases
• Intestinal Diseases

Intervention

Drug:
• alvimopan

• placebo

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Bonaventure	Quebec
Canada	GSK Investigational Site	Chandler	Quebec
Canada	GSK Investigational Site	Kitchener	Ontario
Canada	GSK Investigational Site	Saint John's	Newfoundland and Labrador
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Sudbury	Ontario
Canada	GSK Investigational Site	Winnipeg	Manitoba
Finland	GSK Investigational Site	Helsinki
France	GSK Investigational Site	Bordeaux Cedex
France	GSK Investigational Site	Strasbourg
France	GSK Investigational Site	Vandoeuvre-Les-Nancy
France	GSK Investigational Site	Villejuif Cedex
Hong Kong	GSK Investigational Site	Kwun Tong
New Zealand	GSK Investigational Site	Wellington
Pakistan	GSK Investigational Site	Lahore
Peru	GSK Investigational Site	Lima
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Olsztyn
Poland	GSK Investigational Site	Otwock
Poland	GSK Investigational Site	Poznan
Portugal	GSK Investigational Site	Lisboa
Portugal	GSK Investigational Site	Lisboa
Russian Federation	GSK Investigational Site	Moscow
Spain	GSK Investigational Site	Alcorcon
United Kingdom	GSK Investigational Site	Nottingham
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Duarte	California
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Fountain Valley	California
United States	GSK Investigational Site	Hendersonville	North Carolina
United States	GSK Investigational Site	La Verne	California
United States	GSK Investigational Site	New Port Richey	Florida
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	Tacoma	Washington
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	West Des Moines	Iowa
United States	GSK Investigational Site	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Cubist Pharmaceuticals LLC	GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada,  Finland,  France,  Hong Kong,  New Zealand,  Pakistan,  Peru,  Poland,  Portugal,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of reported adverse events, including serious adverse events
Secondary	Incidence of treatment-limiting toxicities, changes in pain intensity, patient satisfaction, health outcome measures