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OXN PR Compared to OxyPR to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in OA Subjects
This study is currently recruiting participants.
Verified by Mundipharma Research GmbH & Co KG, May 2009
First Received: May 14, 2009   Last Updated: August 26, 2009   History of Changes
Sponsor: Mundipharma Research GmbH & Co KG
Information provided by: Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier: NCT00902837
  Purpose

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

Condition Intervention Phase
Chronic Osteoarthritis
Drug: Oxycodone naloxone prolonged release tablets (OXN)
Drug: oxycodone prolonged release tablet
Drug: oxycodone naloxone tablet
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Mundipharma Research GmbH & Co KG:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: May 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
oxycodone Tablet: Active Comparator
OxyCodone Prolonged release tablets
Drug: oxycodone prolonged release tablet
oxycodone naloxone tablet: Experimental
Oxycodone naloxone prolonged release tablets (OXN)
Drug: Oxycodone naloxone prolonged release tablets (OXN) Drug: oxycodone naloxone tablet

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902837

Contacts
Contact: Margaret C Wilson 01223 424900 info@contact-clinical-trials.com
Contact: Jill Kiteley 01223 424900 info@contact-clinical-trials.com

Locations
Czech Republic
Fakultni nemocnice Olomouc Not yet recruiting
Olomouc, Czech Republic, 77520
Revmatologicka ambul Not yet recruiting
Uherske Hradiste, Czech Republic, 68668
Dr R Flasar Not yet recruiting
Brno, Czech Republic, 60200
FN U Svate Anny Not yet recruiting
Brno, Czech Republic, 65691
Nemocnice Most Not yet recruiting
Most, Czech Republic, 43464
Dr E Lengalove Not yet recruiting
Ceske Budejovice, Czech Republic, 37087
FN Plzen Not yet recruiting
Plzen, Czech Republic, 30460
Dr M Vdoviak Not yet recruiting
Karlovy Vary, Czech Republic, 36001
Urazova nemocnice v Brne Not yet recruiting
Brno, Czech Republic, 66250
Dr Z Urbanova Not yet recruiting
Praha 4, Czech Republic, 14000
VFN Praha Not yet recruiting
Praha 2, Czech Republic, 12800
FN Na Bulovce Not yet recruiting
Praha 8, Czech Republic, 18081
Chirurgicke oddeleni Not yet recruiting
Praha 8, Czech Republic, 18081
Revmatologicka ambulance Not yet recruiting
Praha 4, Czech Republic, 14000
Revmatologicka ambulance Not yet recruiting
Praha 10, Czech Republic, 10100
Germany
Prof Dr Friedemann Webber Recruiting
Senftenberg, Germany, 01968
Gemeinschaftspraxis fuer Not yet recruiting
Greifswald, Germany, 17489
Praxis fur klinische Studien Not yet recruiting
Hamburg, Germany, 22415
Schmerzzentrum Celle Not yet recruiting
Celle, Germany, 29221
Dr H M Frick Not yet recruiting
Rhaunen, Germany, 55624
Dr S Grunert Not yet recruiting
Eichstatt, Germany, 85072
Clinical Research Not yet recruiting
Hamburg, Germany, 22143
Dr U Krauspe Not yet recruiting
Weimar, Germany, 99425
Dr U Schutter Not yet recruiting
Marl, Germany, 45768
Dr E A Lux Not yet recruiting
Lunen, Germany, 44534
Dr I Palutke Not yet recruiting
Bad Klosterlausnitz, Germany, 07639
Dr O Lowenstein Not yet recruiting
Mainz, Germany, 55116
Schmerz und Palliativzentrum Not yet recruiting
Wiesbaden, Germany, 65189
Dr G Voss Not yet recruiting
Berlin, Germany, 10559
Prof Dr F Weber Not yet recruiting
Senftenberg, Germany, 01968
Dr J Hafer Not yet recruiting
Wetzlar, Germany, 35578
Intermed Institue fur Medizinische Forschung & Arzneimittelsicherheit Not yet recruiting
Wiesbaden, Germany, 65185
Israel
Hadassah Medical Center Not yet recruiting
Jerusalem, Israel, 91120
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Sheba Medical Center Not yet recruiting
Tel Hashomer, Israel, 52621
Rambam Medical Center Not yet recruiting
Haifa, Israel, 31096
Sponsors and Collaborators
Mundipharma Research GmbH & Co KG
  More Information

No publications provided

Study ID Numbers: OXN3503, 2008-002670-36
Study First Received: May 14, 2009
Last Updated: August 26, 2009
ClinicalTrials.gov Identifier: NCT00902837     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Mundipharma Research GmbH & Co KG:
randomised
double-blind
double-dummy
parallel-group
non-inferiority
pain locomotor function
improvement in symptoms of constipation
moderate to severe pain due to osteoarthritis (OA)
OXN PR
OxyPR
Moderate to severe chronic nonmalignant OA

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Osteoarthritis
Joint Diseases
Oxycodone
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Rheumatic Diseases
Pharmacologic Actions
Naloxone
Signs and Symptoms
Musculoskeletal Diseases
Sensory System Agents
Therapeutic Uses
Arthritis
Constipation
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010