Clinical trial NCT00259922: Alvimopan For The 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: constipation
gastrointestinal
opioids
pain
non-cancer pain
opioid-induced
bowel dysfunction
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2005-12-01
Enrollment: 485
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 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.


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.

Primary outcomes:
measure: To compare alvimopan with placebo for efficacy in the treatment of OBD
Secondary outcomes:
measure: Safety and tolerability, quality of life, pharmacogenetics (dependent on results from other data)
Other outcomes:
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state: Alabama
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country: New Zealand
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country: Norway
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city: Paradis
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facility: GSK Investigational Site
city: Rådahl
country: Norway
facility: GSK Investigational Site
city: Skien
country: Norway
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city: Athlone, Cape Town
country: South Africa
facility: GSK Investigational Site
city: Erasmuskloof, Pretoria
country: South Africa
facility: GSK Investigational Site
city: Fourways, Johannesburg
country: South Africa
facility: GSK Investigational Site
city: Kempton Park
country: South Africa
facility: GSK Investigational Site
city: Kenilworth, Cape Town
country: South Africa
facility: GSK Investigational Site
city: Lynnwood, Pretoria
country: South Africa
facility: GSK Investigational Site
city: Tygervalley
country: South Africa
facility: GSK Investigational Site
city: Westridge, Mitchells Plain
country: South Africa
facility: GSK Investigational Site
city: Alcorcon
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: El Ferrol
country: Spain
facility: GSK Investigational Site
city: Granada
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Santander
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Jönköping
country: Sweden
facility: GSK Investigational Site
city: Karlstad
country: Sweden
facility: GSK Investigational Site
city: Linköping
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Bern
country: Switzerland
facility: GSK Investigational Site
city: Nottwil
country: Switzerland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
citation: 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.