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

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:

MedlinePlus related topics: Constipation Osteoarthritis

Drug Information available for: Oxycodone Oxycodone hydrochloride Naloxone hydrochloride Naloxone

U.S. FDA Resources

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