Clinical trial NCT00256932: Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Alvimopan 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bowel Dysfunction
Constipation
Keywords: bowel dysfunction
constipation
gastrointestinal
opioids
pain
non-cancer pain
Opioid-induced
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2005-11-22
Enrollment: 518
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion criteria:

* Has 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.

Primary outcomes:
measure: to compare alvimopan with placebo for efficacy in the treatment of OBD
Secondary outcomes:
measure: Safety and tolerability, quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
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facility: GSK Investigational Site
state: Alabama
city: Calera
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state: Alabama
city: Muscle Shoals
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state: Hessen
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state: Hessen
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state: Mecklenburg-Vorpommern
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state: Nordrhein-Westfalen
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state: Nordrhein-Westfalen
city: Koeln
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state: Nordrhein-Westfalen
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state: Nordrhein-Westfalen
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state: Nordrhein-Westfalen
city: Chemnitz
country: Germany
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state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Kiel
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Pinneberg
country: Germany
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state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Hamburg
country: Germany
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city: Hamburg
country: Germany
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city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Cork
country: Ireland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
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city: Reading
country: United Kingdom
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state: Berkshire
city: Slough
country: United Kingdom
facility: GSK Investigational Site
state: Berkshire
city: Cardiff
country: United Kingdom
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state: Glamorgan
city: Glasgow
country: United Kingdom
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state: Lanarkshire
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Blackpool
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Ashford
country: United Kingdom
facility: GSK Investigational Site
state: Middlesex
city: Sunbury-on-Thames
country: United Kingdom
facility: GSK Investigational Site
state: Middlesex
city: Coventry
country: United Kingdom
facility: GSK Investigational Site
state: Warwickshire
city: Bexhill-on-Sea, East Sussex
country: United Kingdom
facility: GSK Investigational Site
city: Leeds
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Yaxley, Peterborough
country: United Kingdom
facility: GSK Investigational Site
city: York
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
citation: Jansen JP, Lorch D, Langan J, Lasko B, Hermanns K, Kleoudis CS, Snidow JW, Pierce A, Wurzelmann J, Mortensen ER. A randomized, placebo-controlled phase 3 trial (Study SB-767905/012) of alvimopan for opioid-induced bowel dysfunction in patients with non-cancer pain. J Pain. 2011 Feb;12(2):185-93. doi: 10.1016/j.jpain.2010.06.012.