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:	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:

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
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

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

Locations

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
FN Plzen
Plzen, 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
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
Praxis fur klinische Studien
Hamburg, Germany, 22415
Clinical Research
Hamburg, Germany, 22143
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 Friedemann Webber
Senftenberg, Germany, 01968
Prof Dr F Weber
Senftenberg, Germany, 01968
Dr U Krauspe
Weimar, Germany, 99425
Dr J Hafer
Wetzlar, Germany, 35578
Schmerz und Palliativzentrum
Wiesbaden, Germany, 65189
Intermed Institue fur Medizinische Forschung & Arzneimittelsicherheit
Wiesbaden, Germany, 65185
Israel
Rambam Medical Center
Haifa, Israel, 31096
Hadassah Medical Center
Jerusalem, Israel, 91120
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Sheba Medical Center
Tel Hashomer, Israel, 52621

Sponsors and Collaborators

Mundipharma Research GmbH & Co KG

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00902837 History of Changes
Other Study ID Numbers:	OXN3503, 2008-002670-36
Study First Received:	May 14, 2009
Last Updated:	July 12, 2011
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
Signs and Symptoms, Digestive
Signs and Symptoms
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naloxone
Oxycodone
Narcotic Antagonists

Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotics
Central Nervous System Depressants
Analgesics
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 09, 2012