OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS)
NCT01197261 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2018-10-23
Summary
The study compares the analgesic efficacy of OXN PR vs placebo in opioid-naive subjects suffering from severe pain due to Bladder Pain Syndrome.
Conditions
- Interstitial Cystitis
- Painful Bladder Syndrome
- Pain
Interventions
- DRUG
-
Oxycodone naloxone prolonged release tablets
2 tablets/ day
- DRUG
-
Placebo tablets
2 tablets/ day
Sponsors & Collaborators
-
Mundipharma Research GmbH & Co KG
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-09-30
- Primary Completion
- 2013-03-31
- Completion
- 2013-06-30
Countries
- Czechia
- Germany
- Hungary
- Poland
- United Kingdom
Study Locations
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