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OpenTrials
Completed

NCT Number: NCT01427270

Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) for Uncontrolled Moderate - Severe Low Back Pain

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.

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Key information

Conditions

Low Back Pain Back Pain Chronic Pain Constipation Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site, Brno, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxycodone/Naloxone controlled-release

Drug

Oxycodone/Naloxone controlled-release tablets (10/5 - 40/20 mg) taken orally every 12 hours

Oxycodone HCl controlled-release

Drug

Oxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours

Other names: OxyContin

Placebo

Drug

Placebo tablets to match OXN or OXY taken orally every 12 hours

Primary outcomes

  1. Overall complete spontaneous bowel movement (CSBM) responder rates

    Time frame: Weeks 1 through 12

    The overall Complete Spontaneous Bowel Movement (CSBM) responder rates over the 12 week double-blind period comparing OXN to OXY

Secondary outcomes

  1. CSBM Responder at least 50% of the weeks in the double-blind period

    Time frame: Weeks 1 through 12

  2. Laxative-free Responder at least 50% of the weeks in the double-blind period

    Time frame: Weeks 1 through 12

Sponsors and collaborators

Lead sponsor

Purdue Pharma LP

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 1, 2011
Registry last updated
Nov 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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