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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT01427283
First received: August 30, 2011
Last updated: February 11, 2015
Last verified: February 2015

August 30, 2011
February 11, 2015
August 2011
October 2014   (final data collection date for primary outcome measure)
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
  • The overall Spontaneous Bowel Movement (SBM) responder rates [ Time Frame: Weeks 1 through 12 ] [ Designated as safety issue: No ]
    The overall Spontaneous Bowel Movement (SBM) responder rates over the 12 week double-blind period comparing OXN to OXY
  • 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.
Complete list of historical versions of study NCT01427283 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Average pain over the last 24 hours responders [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    A "responder" will be defined based on the percentage reduction from the screening mean pain score to the "average pain over the last 24 hours" score at week 12.
  • 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 ]
  • Overall complete spontaneous bowel movements (CSBM) responder rates [ Time Frame: Weeks 1 through 12 ] [ Designated as safety issue: No ]
  • SBM Responder at least 75% of the weeks in the double-blind period [ Time Frame: Weeks 1 through 12 ] [ Designated as safety issue: No ]
  • SBM Responder at least 50% of the weeks in the double-blind period [ Time Frame: Weeks 1 through 12 ] [ Designated as safety issue: No ]
  • CSBM Responder at least 75% of the weeks in the double-blind period [ Time Frame: Weeks 1 through 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 ]
Not Provided
Not Provided
 
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
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

The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and opioid-induced constipation who require around-the-clock opioid therapy.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Low Back Pain
  • Drug: Oxycodone/Naloxone controlled-release
    Oxycodone/Naloxone controlled-release tablets (10/5 - 40/20 mg) taken orally every 12 hours
  • Drug: Oxycodone HCl controlled-release
    Oxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours
    Other Name: OxyContin
  • Drug: Placebo
    Placebo tablets to match OXN or OXY taken orally every 12 hours
  • Experimental: OXN
    Oxycodone/Naloxone controlled-release tablets (OXN)
    Intervention: Drug: Oxycodone/Naloxone controlled-release
  • Active Comparator: OXY
    Oxycodone HCl controlled-release tablets (OXY)
    Intervention: Drug: Oxycodone HCl controlled-release
  • Placebo Comparator: Placebo
    Placebo tablets to match OXN or OXY
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
October 2014
October 2014   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01427283
ONU3705, 2011-005061-20
No
Purdue Pharma LP
Purdue Pharma LP
Not Provided
Not Provided
Purdue Pharma LP
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP