A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT01427283
First received: August 30, 2011
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

The primary objectives are to assess the analgesic efficacy of Oxycodone/Naloxone Controlled-release Tablets (OXN) compared to placebo and to assess the efficacy of OXN for the management of Opioid-induced Constipation (OIC) compared to Oxycodone Controlled-release Tablets (OXY) in subjects with moderate to severe pain due to chronic low back pain who require around-the-clock opioid therapy.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation Who Require Around-the-clock Opioid Therapy

Resource links provided by NLM:


Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:
  • The "average pain over the last 24 hours" score at week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The "average pain over the last 24 hours" score at week 12 of the double-blind period comparing OXN to placebo. The score is based on an 11-point numerical rating scale (NRS): 0 = no pain, 10 = pain as bad as you can imagine.

  • Overall complete spontaneous bowel movement (CSBM) responder rates [ Time Frame: Weeks 1 through 12 ] [ Designated as safety issue: No ]
    The overall Complete Spontaneous Bowel Movement (CSBM) responder rates over the 12 week double-blind period comparing OXN to OXY


Secondary Outcome Measures:
  • Sleep Disturbance Subscale of the Medical Outcomes Study (MOS) Sleep Scale [ Time Frame: Weeks 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • CSBM Responder at least 50% of the weeks in the double-blind period [ Time Frame: Weeks 1 through 12 ] [ Designated as safety issue: No ]
  • Laxative-free Responder at least 50% of the weeks in the double-blind period [ Time Frame: Weeks 1 through 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: August 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 past 2 years, with exception of basal cell carcinoma that has been successfully treated.

Other protocol specific inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01427283

  Show 150 Study Locations
Sponsors and Collaborators
Purdue Pharma LP
  More Information

No publications provided

Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT01427283     History of Changes
Other Study ID Numbers: ONU3705, 2011-005061-20
Study First Received: August 30, 2011
Last Updated: July 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:
Low back pain
Chronic pain
Opioid
Constipation
Moderate to severe

Additional relevant MeSH terms:
Back Pain
Constipation
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Analgesics
Oxycodone
Naloxone
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Narcotic Antagonists

ClinicalTrials.gov processed this record on September 18, 2014