Clinical trial NCT01427270: Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) for Uncontrolled Moderate - Severe Low Back Pain
Official title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects With Uncontrolled Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation Who Require Around-the-clock Opioid Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Keywords: Low back pain
Chronic pain
Opioid
Constipation
Moderate to severe chronic low back pain
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2011-09-01
Enrollment: 455
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: The primary objective is to assess the efficacy of oxycodone/naloxone (OXN) for the management of opioid-induced constipation (OIC) compared to oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and OIC who require around-the-clock opioid therapy.


Eligibility criteria: Inclusion Criteria include:

* Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening period;
* The low back pain must be related to nonmalignant and nonneuropathic conditions and may be with or without radiation;
* Subjects must have a self-reported history of opioid induced constipation (OIC).

Exclusion Criteria include:

* Subjects with rheumatoid arthritis or other inflammatory arthritis;
* Subjects with neuropathic conditions that have been painful or required therapy within the past 3 months;
* Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract or other significant conditions affecting GI motility;
* Subjects with chronic constipation not related to opioid use;
* Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or planned during the study;
* Subjects with a history of malignancy within the past 2 years, with the exception of basal cell carcinoma that has been successfully treated.

Other protocol specific inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Overall complete spontaneous bowel movement (CSBM) responder rates
timeFrame: Weeks 1 through 12
Secondary outcomes:
measure: CSBM Responder at least 50% of the weeks in the double-blind period
timeFrame: Weeks 1 through 12
measure: Laxative-free Responder at least 50% of the weeks in the double-blind period
timeFrame: Weeks 1 through 12
Other outcomes:
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state: Alabama
city: Birmingham
country: United States
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state: Alabama
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city: Orlando
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city: Plantation
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city: Port Orange
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city: Sanford
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country: United States
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city: Houston
country: United States
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state: Texas
city: Houston
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state: Texas
city: Houston
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state: Texas
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state: Texas
city: Humble
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state: Texas
city: North Richland Hills
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state: Texas
city: Plano
country: United States
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state: Texas
city: San Antonio
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city: San Antonio
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state: Texas
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state: Texas
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city: Clinton
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city: Salt Lake City
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city: Salt Lake City
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state: Utah
city: West Jordan
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state: Utah
city: Richmond
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state: Virginia
city: Richmond
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city: Virginia Beach
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state: Virginia
city: Brno
country: Czech Republic
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city: Hradec Kralove
country: Czech Republic
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city: Most
country: Czech Republic
facility: Investigational Site
city: Olomouc
country: Czech Republic
facility: Investigational Site
city: Praha 10
country: Czech Republic
facility: Investigational Site
city: Praha 4 - Krc
country: Czech Republic
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city: Praha 6
country: Czech Republic
facility: Investigational Site
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country: Czech Republic
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country: Czech Republic
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city: Vysoke Myto
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country: Czech Republic
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country: Czech Republic
facility: Investigational Site
city: Catania
country: Italy
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city: Bielsko-Biala
country: Poland
facility: Investigational Site
city: Bydgoszcz
country: Poland
facility: Investigational Site
city: Bydgoszcz
country: Poland
facility: Investigational Site
city: Gdansk
country: Poland
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city: Gdansk
country: Poland
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city: Gdynia
country: Poland
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city: Katowice
country: Poland
facility: Investigational Site
city: Katowice
country: Poland
facility: Investigational Site
city: Lublin
country: Poland
facility: Investigational Site
city: Lublin
country: Poland
facility: Investigational Site
city: Torun
country: Poland
facility: Investigational Site
Study officials:
References: