NCT01918098
Completed
Phase 3
A Randomized, Double-blind, Double-dummy, Parallel-group, Multicenter Study to Demonstrate Improvement in Symptoms of Constipation in Subjects With Moderate to Severe Non-malignant Pain Taking Oxycodone Equivalent of ≥10 mg/Day and ≤50 mg/Day as Oxycodone/Naloxone Prolonged-release (OXN) Compared to Subjects Taking Oxycodone Prolonged-release (OXY) Tablets Alone.
Mundipharma (China) Pharmaceutical Co. Ltd31 sites in 1 country230 target enrollmentSeptember 1, 2013
ConditionsNon Cancer Pain
InterventionsOxycodone/naloxone prolonged release tablets
Overview
- Phase
- Phase 3
- Intervention
- Oxycodone/naloxone prolonged release tablets
- Conditions
- Non Cancer Pain
- Sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
- Enrollment
- 230
- Locations
- 31
- Primary Endpoint
- Bowel function index(BFI) 12 Weeks
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
To determine the improvement in symptoms of constipation in subjects receiving treatment with oxycodone/naloxone prolonged release tablets (OXN) compared to oxycodone prolonged release tablets (OXY) based on the Bowel Function Index (BFI)
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Oxycodone/naloxone prolonged release tablets
Dose strength:5/2.5 mg,10/5mg, 20/10mg,PO,q12h.daily dose from 10/5mg to 50/25mg.treatment duration:12 weeks
Intervention: Oxycodone/naloxone prolonged release tablets
Oxycodone prolonged release tablets
Dose strength:5mg,10mg, 20mg,PO,q12h.daily dose from 10mg to 50mg.treatment duration:12 weeks
Intervention: Oxycodone/naloxone prolonged release tablets
Outcomes
Primary Outcomes
Bowel function index(BFI) 12 Weeks
Time Frame: 12 weeks
Secondary Outcomes
- Modified BPI-SF-Average Pain over the last 24 hours(12 weeks)
Study Sites (31)
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