Alvimopan For The Treatment Of Constipation Due To Opioid... | NCT00259922

Studies
Alvimopan For The Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

NCT00259922

Sponsor

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

Status

Completed

Last Update Posted

Sep 2, 2015Estimated

Enrollment

485Actual

Phase

Phase 3

Conditions

Bowel Dysfunction
Constipation

Interventions

Placebo
Alvimopan
Alviompan

Countries

United States
Australia
Canada
France
Hungary
Netherlands
New Zealand
Norway
South Africa
Spain
Sweden
Switzerland

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

Status Module

Record Verification Date

Sep 2009

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 2005

Primary Completion Date

Jun 2006Actual

Completion Date

Not provided

First Submitted Date

Nov 29, 2005

First Submission Date that Met QC Criteria

Nov 29, 2005

First Posted Date

Dec 1, 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

Sep 1, 2015

Last Update Posted Date

Sep 2, 2015Estimated

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 (1:1:1) to one of 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.

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

485Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
Alvimopan 0.5 mg once daily	Experimental	0.5 mg once daily (QD)	Drug: Alvimopan
Alvimopan 0.5 mg twice daily	Experimental	0.5 mg twice daily (BID)	Drug: Alviompan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo	Placebo
Alvimopan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare alvimopan with placebo for efficacy in the treatment of OBD

Secondary Outcomes

Measure	Description	Time Frame
Safety and tolerability, quality of life, pharmacogenetics (dependent on results from other data)

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).
Willing to report daily bowel symptoms.

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.
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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21292168	Result	Irving G, Penzes J, Ramjattan B, Cousins M, Rauck R, Spierings EL, Kleoudis CS, Snidow JW, Pierce A, Wurzelmann J, Mortensen ER. A randomized, placebo-controlled phase 3 trial (Study SB-767905/013) of alvimopan for opioid-induced bowel dysfunction in patients with non-cancer pain. J Pain. 2011 Feb;12(2):175-84. doi: 10.1016/j.jpain.2010.06.013.

ID	Term
D007410	Intestinal Diseases
D003248	Constipation
D010146	Pain

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