OXN PR Compared to OxyPR to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in OA Subjects
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| ClinicalTrials.gov Identifier: NCT00902837 |
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Recruitment Status :
Completed
First Posted : May 15, 2009
Last Update Posted : December 13, 2012
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Sponsor:
Mundipharma Research GmbH & Co KG
Information provided by (Responsible Party):
Mundipharma Research GmbH & Co KG
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Osteoarthritis | Drug: Oxycodone naloxone prolonged release tablets (OXN) Drug: oxycodone prolonged release tablet Drug: oxycodone naloxone tablet | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 181 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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. |
| Study Start Date : | May 2009 |
| Actual Primary Completion Date : | April 2010 |
| Actual Study Completion Date : | July 2010 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Osteoarthritis
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: oxycodone Tablet
OxyCodone Prolonged release tablets
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Drug: oxycodone prolonged release tablet |
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Experimental: oxycodone naloxone tablet
Oxycodone naloxone prolonged release tablets (OXN)
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Drug: Oxycodone naloxone prolonged release tablets (OXN) Drug: oxycodone naloxone tablet |
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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 | |
| Prof Dr F Weber | |
| Senftenberg, Germany, 01968 | |
| 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
Additional Information:
| Responsible Party: | Mundipharma Research GmbH & Co KG |
| ClinicalTrials.gov Identifier: | NCT00902837 History of Changes |
| Other Study ID Numbers: |
OXN3503 2008-002670-36 |
| First Posted: | May 15, 2009 Key Record Dates |
| Last Update Posted: | December 13, 2012 |
| Last Verified: | December 2012 |
Keywords provided by Mundipharma Research GmbH & Co KG:
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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:
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Osteoarthritis Constipation Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Signs and Symptoms, Digestive Signs and Symptoms Oxycodone |
Naloxone Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists |