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 currently recruiting participants.
Verified March 2014 by Purdue Pharma LP
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT01427283
First received: August 30, 2011
Last updated: March 21, 2014
Last verified: March 2014

August 30, 2011
March 21, 2014
August 2011
March 2015   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01427283 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 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.

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.
 
Recruiting
900
May 2015
March 2015   (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 be:

    1. On ongoing opioid analgesic medication for at least 4 weeks prior to the screening visit and on a stable dose of opioid analgesic medication equivalent to 20 to 160 mg (inclusive) of morphine per day for the last 2 weeks prior to the screening visit, or
    2. Taking 0 to less than 20 mg of morphine or its equivalent per day for the last 2 weeks prior to the screening visit due to OIC.

Subjects taking any dose of tramadol or wearing ≤ 70 mcg/h buprenorphine patch (as long as it does not exceed highest approved dose for buprenorphine in the country the study site is located) on a stable regimen for the last 2 weeks prior to the screening visit will also meet this criterion;

  • For subjects on <40 mg of morphine or equivalent per day, both the "average pain over the last 24 hours" and the "average pain over the past 14 days" scores at the screening visit must be ≥ 5;
  • Subjects must have a self-reported history of OIC as defined by having had while on opioids <3 complete spontaneous bowel movements (CSBMs) per week and 1 or more of the following for at least 25% of bowel movements (BMs):

    1. Hard or lumpy stools
    2. Straining during bowel movements
    3. A sensation of incomplete evacuation after bowel movements

A CSBM is defined as a spontaneous bowel movement (SBM) that is accompanied by the subject self-reporting a feeling of complete evacuation. An SBM is defined as a bowel movement occurring in the absence of laxative or enema use in the previous 24 hours;

  • Subjects must be willing to discontinue their current laxative regimen, including prokinetic drugs (e.g., metoclopramide);
  • Subjects must agree to the use of oral bisacodyl as their only laxative rescue medication;
  • Subjects who are willing and able to be compliant with the protocol, and who provide written informed consent.

Exclusion Criteria include:

  • Subjects with any contraindication or any history of hypersensitivity to oxycodone, naloxone, or other opioids. This does not include subjects who have experienced common opioid side effects (e.g., nausea, constipation);
  • Subjects with neurologic signs, or presumptive or confirmed compression of a spinal nerve root;
  • Subjects with acute spinal cord compression, acute compression fracture, seronegative spondyloarthropathy, acute nerve root compression, cauda equina compression, fibromyalgia, reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), diabetic amyotrophy, meningitis, discitis, or back pain due to secondary infection, tumor, or postherpetic neuralgia;
  • Subjects with gout, unless controlled on stable suppressive treatment with colchicine or uric-acid-lowering therapy without any attacks for ≥ 2 years and the subject has not been using NSAIDs or COX-2 inhibitors on a regular basis;
  • Subjects with pseudogout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or other inflammatory arthritis. Subjects with neuropathic conditions that have been painful or required therapy (such as gabapentin or other neuropathic pain treatments) within the past 3 months are also excluded;
  • Subjects with evidence of significant structural abnormalities of the gastrointestinal tract (e.g., bowel obstruction, strictures) or any diseases/conditions that affect bowel transit (e.g., ileus, uncontrolled hypothyroidism);
  • Subjects with a history of prior chronic constipation (including functional constipation or pelvic floor dyssynergy) that was present for more than three months and that was not related to opioid use;
  • Subjects currently with clinically diagnosed diarrhea, defined as 3 stools/day that are loose or watery in nature within 2 weeks before visit 3;
  • Subjects with irritable bowel syndrome (IBS) or inflammatory bowel disease (eg, ulcerative colitis, Crohn's disease);
  • Subjects who had surgery that may affect gastrointestinal motility or gastrointestinal pain within 2 months prior to the start of the screening period, or who plan such surgery during the study;
  • Subjects with a history of fecal incontinence;
  • Subjects who require ongoing therapy with medications (other than opioids) that have contributed to the subjects' constipation in the judgment of the investigator;
  • The subject must not have had any of the following within the indicated time periods before screening:

    • nerve/plexus block in the lumbar spine within 4 weeks
    • neuroablation in the lumbar spine within 6 weeks
    • Botulinum toxin injection for pain control in the lumbar spine within 3 months
    • steroid injections of the lumbar spine within 6 weeks or any intravenous or intramuscular steroid injections within 4 weeks;
  • 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;
  • Subjects with current uncontrolled depression or other uncontrolled psychiatric disorder (subjects with controlled depression or other psychiatric disorder must be on stable medication for at least 1 month prior to the screening visit to participate in the study);
  • Subjects currently taking, or who have taken naloxone, naltrexone, methylnaltrexone, or alvimopan within 10 days before the screening visit;
  • Subjects who have used any investigational medication within 30 days prior to the first dose of study medication;
  • Subjects who had received a monoamine oxidase inhibitor within the last 14 days prior to the screening visit;
  • Subjects with any condition in which opioids are contraindicated, such as severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma, or paralytic ileus;
  • Subjects with increase of intracranial pressure and/or epilepsy (not including history of pediatric febrile seizures);
  • Subjects with clinically significant cardiovascular disease or dysrhythmias;
  • Subjects with biliary tract disease, hypothyroidism, adrenal cortical insufficiency, or any other medical condition that in the investigator's opinion is inadequately treated and precludes entry into the study;
  • Subjects who, in the opinion of the Investigator, are unsuitable to participate in this study for any other reason;
  • Subjects who have received study drug in a clinical study of OXN or ONU.

Other protocol specific inclusion/exclusion criteria may apply.

Both
18 Years and older
No
Contact: Patient Recruitment Specialist 1-855-253-3456 convergestudy@quintiles.com
United States
 
NCT01427283
ONU3705, 2011-005061-20
No
Purdue Pharma LP
Purdue Pharma LP
Not Provided
Not Provided
Purdue Pharma LP
March 2014

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