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

Primary Purpose

Cancer, Bowel Dysfunction

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
alvimopan
placebo
Sponsored by
Cubist Pharmaceuticals LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring opioids, constipation, opioid-induced bowel dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Alvimopan 0.5 mg Twice Daily (BID)

Alvimopan 1 mg Once Daily (QD)

Alvimopan 1 mg Twice Daily (BID)

Placebo

Arm Description

0.5 milligrams (mg) of alvimopan was administered orally once in the morning and once in the evening.

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.

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.

Placebo was administered orally once in the morning and once in evening.

Outcomes

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

Full Information

First Posted
August 24, 2005
Last Updated
September 1, 2015
Sponsor
Cubist Pharmaceuticals LLC
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00135577
Brief Title
Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects
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 Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cubist Pharmaceuticals LLC
Collaborators
GlaxoSmithKline

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Bowel Dysfunction
Keywords
opioids, constipation, opioid-induced bowel dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alvimopan 0.5 mg Twice Daily (BID)
Arm Type
Experimental
Arm Description
0.5 milligrams (mg) of alvimopan was administered orally once in the morning and once in the evening.
Arm Title
Alvimopan 1 mg Once Daily (QD)
Arm Type
Experimental
Arm Description
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.
Arm Title
Alvimopan 1 mg Twice Daily (BID)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo was administered orally once in the morning and once in evening.
Intervention Type
Drug
Intervention Name(s)
alvimopan
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Incidence of reported adverse events, including serious adverse events
Secondary Outcome Measure Information:
Title
Incidence of treatment-limiting toxicities, changes in pain intensity, patient satisfaction, health outcome measures

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
GSK Investigational Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
GSK Investigational Site
City
La Verne
State/Province
California
ZIP/Postal Code
91750
Country
United States
Facility Name
GSK Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
GSK Investigational Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
GSK Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
GSK Investigational Site
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
GSK Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
GSK Investigational Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608
Country
United States
Facility Name
GSK Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
GSK Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
GSK Investigational Site
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28793
Country
United States
Facility Name
GSK Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
GSK Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
GSK Investigational Site
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
GSK Investigational Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Facility Name
GSK Investigational Site
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
GSK Investigational Site
City
Bonaventure
State/Province
Quebec
ZIP/Postal Code
G0C 1E0
Country
Canada
Facility Name
GSK Investigational Site
City
Chandler
State/Province
Quebec
ZIP/Postal Code
G0C 1K0
Country
Canada
Facility Name
GSK Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
GSK Investigational Site
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
GSK Investigational Site
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
GSK Investigational Site
City
Vandoeuvre-Les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
GSK Investigational Site
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
GSK Investigational Site
City
Kwun Tong
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Wellington
ZIP/Postal Code
6002
Country
New Zealand
Facility Name
GSK Investigational Site
City
Lahore
ZIP/Postal Code
54600
Country
Pakistan
Facility Name
GSK Investigational Site
City
Lima
ZIP/Postal Code
Lima 34
Country
Peru
Facility Name
GSK Investigational Site
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
Facility Name
GSK Investigational Site
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
GSK Investigational Site
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
GSK Investigational Site
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
GSK Investigational Site
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
GSK Investigational Site
City
Lisboa
ZIP/Postal Code
1070
Country
Portugal
Facility Name
GSK Investigational Site
City
Lisboa
ZIP/Postal Code
1800
Country
Portugal
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
117216
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Alcorcon
ZIP/Postal Code
28922
Country
Spain
Facility Name
GSK Investigational Site
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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