OXN PR Compared to OxyPR to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in OA Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier:
NCT00902837
First received: May 14, 2009
Last updated: December 12, 2012
Last verified: December 2012

May 14, 2009
December 12, 2012
May 2009
April 2010   (final data collection date for primary outcome measure)
To demonstrate that treatment with OXN PR tablets is non-inferior to treatment with OxyPR with regards to analgesic efficacy & locomotor function. To demonstrate that subjects with moderate to severe OA pain taking oxycodone/naloxone prolonged re [ Time Frame: End of 12 week study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00902837 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
OXN PR Compared to OxyPR to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in OA Subjects
Randomised, Double-blind, Double-dummy, Parallel-group Multicentre Study to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in Subjects With Moderate to Severe Pain Due to Osteoarthritis (OA) of the Knee &/or Hip Taking Oxycodone Equivalent of 20 - 80 mg/Day as Oxycodone/Naloxone Prolonged Release (OXN PR) Compared to Subjects Taking Oxycodone Prolonged Release Tablets (OxyPR) Alone.

The primary objectives are

  • to demonstrate that the treatment with OXN PR tablets is non-inferior to the treatment with OxyPR with regards to analgesic efficacy and locomotor function.
  • to demonstrate that subjects with moderate to severe OA pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone

Subjects with moderate to severe pain due to osteoarthritis (OA) will be randomised to oxycodone/naloxone prolonged release (OXN PR) or oxycodone prolonged release tablets (OxyPR) alone to demonstrate that the treatment with OXN PR tablets is non-inferior to the treatment with OxyPR with regards to analgesic efficacy and locomotor function and to demonstrate that subjects taking OXN PR have improvement in symptoms of constipation compared to subjects taking OxyPR alone.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Osteoarthritis
  • Drug: Oxycodone naloxone prolonged release tablets (OXN)
  • Drug: oxycodone prolonged release tablet
  • Drug: oxycodone naloxone tablet
  • Active Comparator: oxycodone Tablet
    OxyCodone Prolonged release tablets
    Intervention: Drug: oxycodone prolonged release tablet
  • Experimental: oxycodone naloxone tablet
    Oxycodone naloxone prolonged release tablets (OXN)
    Interventions:
    • Drug: Oxycodone naloxone prolonged release tablets (OXN)
    • Drug: oxycodone naloxone tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
181
July 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Moderate to severe chronic nonmalignant OA and that require around-the-clock opioid therapy.

Exclusion criteria:

  • Females who are pregnant or lactating.
  • Subjects with evidence of significant structural abnormalities of the gastrointestinal tract.
  • Subjects with evidence of impaired liver/kidney function upon entry into the study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Hungary,   Finland,   Germany,   Czech Republic,   Spain
 
NCT00902837
OXN3503, 2008-002670-36
No
Mundipharma Research GmbH & Co KG
Mundipharma Research GmbH & Co KG
Not Provided
Not Provided
Mundipharma Research GmbH & Co KG
December 2012

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