Efficacy of Oxycodone/Naloxone(OXN), Versus Oxycodone (OXY), for the Reduction of Intensity of Opioid-induced Constipation in Pain Patients

Phase 3

Terminated

• Conditions: Constipation; Pain
• Interventions: Drug: Oxycodone PR Tablets; Drug: Oxycodone Naloxone

• Registration Number: NCT01014559
• Lead Sponsor: Mundipharma SAS

Brief Summary

The primary objective of this trial is to study the efficacy of oxycodone/naloxone prolonged release tablets (OXN PR), compared to oxycodone prolonged release tablets (Oxy PR), for the reduction of the intensity of opioid-induced constipation symptoms in patients treated for cancer or non-cancer pain.

Detailed Description

Eligible patients with documented cancer or non-cancer pain, either currently receiving a WHO step II opioid and requiring the initiation of a WHO step III opioid or currently receiving a WHO step III opioid, and having opioid-related constipation defined by either a KESS score ≥9 or the current use of laxatives (≥3 times per week), will be randomly assigned to receive either OXN PR or Oxy PR. Randomisation will be stratified on the cause of pain: cancer or non-cancer.

Any patient having completed the study and wishing to receive OXN PR afterwards may enter an optional open extension phase. During this phase, all patients will receive OXN PR and be managed as per the usual practice in the center until commercial OXN PR is available in France (with a limit of 1 year after Day 28). Adverse events will be assessed at each visit.

Study Timeline

• Study First Submitted: 2009-11-16
• Study First Submitted QC: 2009-11-16
• Study First Posted: 2009-11-17
• Study Start: 2010-02
• Primary Completion: 2011-06
• Study Completion: 2013-02
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-25
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tablet	Oxycodone PR Tablets	Oxycodone PR Tablets
Prolonged release tablet	Oxycodone Naloxone	OxyCodone Naloxone controlled release tablet

Primary Outcome Measures

Name	Time	Method
Change of intensity of constipation symptoms, as assessed by the BFI from baseline to Day 28. The BFI is the mean value of 3 single items: Ease of defecation; Feeling of incomplete bowel evacuation; Personal judgement of constipation.	28 days

Secondary Outcome Measures

Name	Time	Method
Change of BFI from baseline (bl) to Days 7,14,21. Change of PAC-SYM score from bl to Days 7,14,21,28. Change of KESS score from bl to Days 7,14,21,28. Frequency of laxative medication use between Day 0 & Day 28. Change of pain as assessed by BPI-SF	Days 7, 14 and 21

Trial Locations

Locations (1)

Hôpital Louis Pradel; 🇫🇷 Bron, France