OXN PR Compared to OxyPR to Demonstrate Non-inferiority i... | NCT00902837

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.

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

May 14, 2009

First Submission Date that Met QC Criteria

May 14, 2009

First Posted Date

May 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2018

Last Update Posted Date

Oct 22, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Conditions Module

Conditions

Chronic Osteoarthritis

Keywords

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

181Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxycodone naloxone prolonged release tablets (OXN)	Drug		oxycodone naloxone tablet
oxycodone prolonged release tablet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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		End of 12 week study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Label	URL
Text results available on website	View source

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Israel

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Facility	Status	City	State	ZIP	Country	Contacts
		Ghent			Belgium
Dr R Flasar