To Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Between OXN PR Higher Dose & Lower Dose Tablet Strengths in Subjects With Non-cancer or Cancer Pain
Launched by MUNDIPHARMA RESEARCH GMBH & CO KG · Dec 19, 2014
Trial Information
Current as of May 14, 2025
Completed
Keywords
ClinConnect Summary
Study OXN3508 is a multicenter double-blind, double-dummy, randomised, cross-over, 2-period, phase III study in male and female subjects with severe non-malignant or malignant pain that requires around-the-clock opioid therapy at a daily dose of 120/60 mg or 160/80 mg oxycodone/naloxone prolonged release (OXN PR).
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- • Subjects who are receiving WHO step III opioid analgesic medication for the treatment of non-malignant or malignant pain.
- • Documented history of non-malignant or malignant pain that requires around-the-clock opioid therapy
- • Exclusion Criteria
- • Females who are pregnant or lactating.
- • Subjects with evidence or significant structural abnormalities of the gastrointestinal tract.
- • Subjects with evidence of impaired liver/kidney function upon entry into the study.
About Mundipharma Research Gmbh & Co Kg
Mundipharma Research GmbH & Co. KG is a global pharmaceutical company dedicated to the development and commercialization of innovative therapies that address unmet medical needs. With a strong emphasis on research and development, Mundipharma focuses on a diverse range of therapeutic areas, including pain management, oncology, and respiratory conditions. The company collaborates with healthcare professionals and research institutions to advance clinical trials that enhance patient outcomes. Committed to ethical practices and regulatory compliance, Mundipharma strives to deliver high-quality medicines that improve the quality of life for patients around the world.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Mainz, , Germany
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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