A clinical trial to assess the effectiveness of oxycodone/naloxone combination drug on severe, ongoing, controlled low back pain and opioid induced constipation, in patients already taking opioids for the management of this pain.
- Conditions
- Opioid-induced Constipation & Moderate to Severe Chronic Low back PainMedDRA version: 15.0Level: PTClassification code 10003988Term: Back painSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 15.0Level: LLTClassification code 10071128Term: Opioid induced constipationSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2011-005061-20-PL
- Lead Sponsor
- Purdue Pharma L.P.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 900
1. 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.
2. The low back pain must be related to nonmalignant and nonneuropathic conditions and without radiation or with only proximal radiation
3. Subjects must be on opioid analgesic therapy for low back pain which:
- Has been ongoing for at least 4 weeks prior to the screening visit (visit 1) and
- Consists of a stable opioid analgesic medication dose equivalent to 40 to 160 mg (inclusive) of morphine per day for the last 2 weeks prior to the screening visit
4. Subjects must require continuation of opioid analgesic treatment in the range of 40 to 160 mg (inclusive) of morphine or its equivalent daily and be likely to benefit from chronic around-the-clock opioid therapy for the duration of the study.
5. Subjects must have an average pain over the last 14 days score = 4 at the screening visit (visit 1), on their current opioid analgesic medication and, if applicable, nonopioid medication.
6. Subjects must have an average pain over the last 24 hours score = 4 at the screening visit (visit 1), on their current opioid analgesic medication and, if applicable, nonopioid medication.
7. Subjects must have a history of OIC, as determined by the investigator.
8. Subjects must be willing to discontinue their current laxative regimen, including prokinetic drugs
9. Subjects must agree to the use of oral bisacodyl as their only laxative rescue medication.
10. For subjects receiving adjunct therapy such treatment must be stopped before treatment with OXY is initiated, or, if continued, the treatment should have been at a stable dose/intensity and frequency for 2 weeks
11. If taking oral corticosteroids, subjects must be on at a stable dose for at least 6 weeks before the screening visit (visit 1) and be willing to maintain that dose throughout the study.
12. Female subjects who are premenopausal or postmenopausal less than 1 year, or who have not had surgical sterilization must have a negative serum pregnancy test
13. Subjects who are willing and able to be compliant with the protocol, and who provide written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 899
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
1. Subjects with any contraindication or any history of hypersensitivity to oxycodone, naloxone, or other opioids.
2. Subjects with any contraindication to bisacodyl.
3. Subjects with pain with distal radiation (below the knee) with or without neurologic signs, or presumptive or confirmed compression of a spinal nerve root
4. 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.
5. Subjects with gout, unless controlled on stable suppressive treatment with colchicine or uricacid-lowering therapy without any attacks for = 2 years and the subject has not been using
NSAIDs or COX-2 inhibitors on a regular basis.
6. Subjects with pseudogout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or other inflammatory arthritis, or neuropathic pain conditions
7. Subjects who, in the opinion of the investigator, are exhibiting significant opioid withdrawal such that they should not be in the study.
8. 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).
9. 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.
10. Subjects currently with clinically diagnosed diarrhoea, defined as 3 stools/day that are loose or watery in nature within 2 weeks before visit 3.
11. Subjects with irritable bowel syndrome (IBS) or inflammatory bowel disease
12. 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.
13. Subjects with a history of fecal incontinence.
14. Subjects who require ongoing therapy with medications (other than opioids) that have contributed to the subjects‘ constipation in the judgment of the investigator.
15. Subjects with hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
16. Subjects who cannot or will not agree to completely stop all incoming opioid and nonopioid analgesic medications and other medications used for chronic pain
17. Subjects who cannot or will not agree to forego the following treatments during the study: nerve/plexus blocks or ablation, neurosurgical procedures for pain control, Botulinum toxin
injections for pain control in the lumbar spine, steroid injections in the lumbar spine, or inhalation analgesia.
18. Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit (visit 1) or planned during the study.
19. Subjects with a history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated.
20. Subjects with current uncontrolled depression or other uncontrolled psychiatric disorder
21. Subjects with an average QTcF of > 470 msec at the screening visit (visit 1)
22. Subjects with evidence of impaired liver function and impaired kidney function upon entry
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method