This trial is active, not recruiting.

Conditions pain, constipation
Treatments oxycodone/naloxone prolonged release (oxn pr) tablets, oxycodone prolonged release (oxypr) tablets
Phase phase 3
Sponsor Mundipharma Research GmbH & Co KG
Start date September 2011
End date February 2014
Trial size 270 participants
Trial identifier NCT01438567, 2010-021995-27, OXN3506


The primary research objective is to demonstrate that subjects taking OXN PR have improvement in symptoms of constipation as measured by the Bowel Function Index (BFI) compared to subjects taking OxyPR tablets alone with cancer and non-cancer related pain without reducing the effectiveness of pain relief as measured by the Brief Pain Inventory (BPI).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
oxycodone/naloxone prolonged release (oxn pr) tablets
Drug: Oxycodone/naloxone prolonged release tablets Arms: OXN PR Dosage: 2x50/25mg daily or 2x60/30mg daily or 2x70/35mg daily or 2x80/40mg daily
(Active Comparator)
oxycodone prolonged release (oxypr) tablets
Drug: Oxycodone prolonged release tablets Arms: OxyPR Dosage: 2x50mg daily or 2x60mg daily or 2x70mg daily or 2x80mg daily

Primary Outcomes

Bowel function Index (BFI)
time frame: 5 weeks and a 6 month extension

Secondary Outcomes

Pain Intensity Scale (PIS)
time frame: 5 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria - Subjects who are receiving WHO step III opioid analgesic medication for the treatment of non-malignant or malignant pain. - Documented history of non-malignant or malignant pain that requires around-the-clock opioid therapy Exclusion Criteria - Females who are pregnant or lactating. - Subjects with evidence or significant structural abnormalities of the gastrointestinal tract. - Subjects with evidence of impaired liver/kidney function upon entry into the study.

Additional Information

Official title A Randomised, Double-blind, Double-dummy, Parallel-group Multicenter Study to Demonstrate Improvement in Symptoms of Constipation and Non-inferiority in Analgesic Efficacy in Subjects With Non-malignant or Malignant Pain That Require Around-the-clock Opioid Therapy Taking 50/25 - 80/40 mg Twice Daily as Oxycodone/Naloxone Prolonged Release (OXN PR) Tablets Compared to Subjects Taking 50 - 80 mg Twice Daily Oxycodone Prolonged Release (OxyPR) Tablets Alone
Description The study OXN3506 is a multicentre, multiple-dose, randomised, double-blind, double-dummy, active-controlled, parallel-group study in male and female subjects with non-malignant or malignant pain requiring opioids to assess analgesic efficacy and symptoms of constipation secondary to opioid treatment. Subjects will be randomised to two treatment groups and will be treated with OXN PR or OxyPR for up to 5 weeks. The study is composed of three phases, a pre-randomisation phase, a double-blind phase and an extension phase.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Mundipharma Research GmbH & Co KG.