Long-Term Safety Evaluation Of Treatment Of Constipation... | NCT00241722

Studies
Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

NCT00241722

Sponsor

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status

Completed

Last Update Posted

Aug 30, 2017Actual

Enrollment

805Actual

Phase

Phase 3

Conditions

Bowel Dysfunction
Constipation

Interventions

Alvimopan
Placebo

Countries

United States
Australia
Austria
Canada
Denmark
Finland
Hong Kong
Hungary
Ireland
Netherlands
New Zealand
Poland
Spain
Sweden
Switzerland
Taiwan
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
SB-767905/014	Other Identifier	Cubist Study Number

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Aug 1, 2005Actual

Primary Completion Date

Feb 1, 2007Actual

Completion Date

Feb 1, 2007Actual

First Submitted Date

Oct 17, 2005

First Submission Date that Met QC Criteria

Oct 17, 2005

First Posted Date

Oct 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2017

Last Update Posted Date

Aug 30, 2017Actual

Name	Class
GlaxoSmithKline	INDUSTRY

Description Module

Brief Summary

Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1) to alvimopan or placebo. The primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerability in the treatment of OBD. Participants will be required to attend 8 clinic visits over approximately 1 year.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

805Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alvimopan 0.5 mg Twice Daily (BID)	Experimental	0.5 milligrams (mg) of alvimopan was administered orally twice daily (BID) for 12 months.	Drug: Alvimopan
Placebo	Placebo Comparator	Placebo was administered orally BID for 12 months.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alvimopan	Drug		Alvimopan 0.5 mg Twice Daily (BID)
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare alvimopan with placebo for long-term safety and tolerability		12 months

Secondary Outcomes

Measure	Description	Time Frame
Quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data)		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Consented to participate in this study.
Taking opioid therapy for persistent non-cancer pain.
Has bowel dysfunction mainly due to opioids.
Has bowel dysfunction since starting opioids as defined by infrequent bowel movements and additional bowel-related symptoms.
Willing to discontinue laxative therapy (will be provided study-specific standardized laxative if needed).

Exclusion criteria:

Pregnant, lactating, or planning to become pregnant.
Not ambulatory.
Participated in another trial with an investigational drug in the past 30 days.
Taking opioids for the management of drug addiction or cancer-related pain.
Severe constipation whereby the subject is at immediate risk of developing serious complications of constipation.
Gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.
Human Immunodeficiency Virus (HIV)-infected, has active hepatitis, or has ever been infected with hepatitis C.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials, MD	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Birmingham	Alabama	35215	United States
GSK Investigational Site

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D009461	Neurologic Manifestations