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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01427270
Recruitment Status : Completed
First Posted : September 1, 2011
Last Update Posted : November 7, 2014
Information provided by (Responsible Party):
Purdue Pharma LP

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: Oxycodone/Naloxone controlled-release Drug: Oxycodone HCl controlled-release Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 455 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: OXN
Oxycodone/Naloxone controlled-release tablets (OXN)
Drug: Oxycodone/Naloxone controlled-release
Oxycodone/Naloxone controlled-release tablets (10/5 - 40/20 mg) taken orally every 12 hours

Active Comparator: OXY
Oxycodone HCl controlled-release tablets (OXY)
Drug: Oxycodone HCl controlled-release
Oxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours
Other Name: OxyContin

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

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01427270

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Sponsors and Collaborators
Purdue Pharma LP

Responsible Party: Purdue Pharma LP Identifier: NCT01427270     History of Changes
Other Study ID Numbers: ONU3704
2011-005060-26 ( EudraCT Number )
First Posted: September 1, 2011    Key Record Dates
Last Update Posted: November 7, 2014
Last Verified: November 2014

Keywords provided by Purdue Pharma LP:
Low back pain
Chronic pain
Moderate to severe chronic low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists