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:
Mundipharma Research GmbH & Co KG
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
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 ]
| Enrollment: | 181 |
| Study Start Date: | May 2009 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: oxycodone Tablet
OxyCodone Prolonged release tablets
|
Drug: oxycodone prolonged release tablet |
|
Experimental: oxycodone naloxone tablet
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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902837
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902837
Locations
| Belgium | |
| Gent, Belgium | |
| Czech Republic | |
| Dr R Flasar | |
| Brno, Czech Republic, 60200 | |
| FN U Svate Anny | |
| Brno, Czech Republic, 65691 | |
| Urazova nemocnice v Brne | |
| Brno, Czech Republic, 66250 | |
| Dr E Lengalove | |
| Ceske Budejovice, Czech Republic, 37087 | |
| Dr M Vdoviak | |
| Karlovy Vary, Czech Republic, 36001 | |
| Nemocnice Most | |
| Most, Czech Republic, 43464 | |
| Fakultni nemocnice Olomouc | |
| Olomouc, Czech Republic, 77520 | |
| Plzen-Lochotin, Czech Republic, 30460 | |
| Revmatologicka ambulance | |
| Praha 10, Czech Republic, 10100 | |
| VFN Praha | |
| Praha 2, Czech Republic, 12800 | |
| Dr Z Urbanova | |
| Praha 4, Czech Republic, 14000 | |
| Revmatologicka ambulance | |
| Praha 4, Czech Republic, 14000 | |
| Chirurgicke oddeleni | |
| Praha 8, Czech Republic, 18081 | |
| FN Na Bulovce | |
| Praha 8, Czech Republic, 18081 | |
| Revmatologicka ambul | |
| Uherske Hradiste, Czech Republic, 68668 | |
| Finland | |
| Kuopio, Finland | |
| Germany | |
| Dr I Palutke | |
| Bad Klosterlausnitz, Germany, 07639 | |
| Dr G Voss | |
| Berlin, Germany, 10559 | |
| Schmerzzentrum Celle | |
| Celle, Germany, 29221 | |
| Dr S Grunert | |
| Eichstatt, Germany, 85072 | |
| Gemeinschaftspraxis fuer | |
| Greifswald, Germany, 17489 | |
| Clinical Research | |
| Hamburg, Germany, 22143 | |
| Praxis fur klinische Studien | |
| Hamburg, Germany, 22415 | |
| Dr E A Lux | |
| Lunen, Germany, 44534 | |
| Dr O Lowenstein | |
| Mainz, Germany, 55116 | |
| Dr U Schutter | |
| Marl, Germany, 45768 | |
| Dr H M Frick | |
| Rhaunen, Germany, 55624 | |
| Senftenberg, Germany, 01968 | |
| Prof Dr F Weber | |
| Senftenberg, Germany, 01968 | |
| Dr U Krauspe | |
| Weimar, Germany, 99425 | |
| Dr J Hafer | |
| Wetzlar, Germany, 35578 | |
| Intermed Institue fur Medizinische Forschung & Arzneimittelsicherheit | |
| Wiesbaden, Germany, 65185 | |
| Schmerz und Palliativzentrum | |
| Wiesbaden, Germany, 65189 | |
| Hungary | |
| Mezokovesd, Hungary | |
| Spain | |
| Madrid, Spain | |
Sponsors and Collaborators
Mundipharma Research GmbH & Co KG
More Information
Additional Information:
No publications provided
| Responsible Party: | Mundipharma Research GmbH & Co KG |
| ClinicalTrials.gov Identifier: | NCT00902837 History of Changes |
| Other Study ID Numbers: | OXN3503, 2008-002670-36 |
| Study First Received: | May 14, 2009 |
| Last Updated: | December 12, 2012 |
| 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:
|
Constipation Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Signs and Symptoms Signs and Symptoms, Digestive Naloxone Oxycodone Analgesics |
Analgesics, Opioid Central Nervous System Agents Central Nervous System Depressants Narcotic Antagonists Narcotics Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015