Clinical trial NCT02321397: To Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Between OXN PR Higher Dose & Lower Dose Tablet Strengths in Subjects With Non-cancer or Cancer Pain
Official title: Randomised, Double-blind, Double-dummy, Cross-over Multicenter Study to Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Taking Oxycodone Equivalents of 120 & 160 mg Per Day as Achieved With the Higher OXN PR Tablet Strengths (OXN60/30 mg PR, OXN80/40 mg PR) BID Compared to the Identical Daily Dose Taken as a Combination of Lower Tablet Strengths in Subjects With Non-malignant or Malignant Pain That Requires Around-the-clock Opioid Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Malignant Pain
Non-malignant Pain
Keywords: oxycodone naloxone combination
severe chronic and non-malignant pain
Malignant and non-malignant pain that requires around-the clock opioid therapy
Lead sponsor: Mundipharma Research GmbH & Co KG
Sponsor class: INDUSTRY
First posted: 2014-12-22
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is aimed to demonstrate equivalence between combinations of lower strength OXN PR tablets (OXN PR LST) and single higher strength OXN PR tablets (OXN PR HST) taken at the same overall daily dose.

Detailed description: Study OXN3508 is a multicenter double-blind, double-dummy, randomised, cross-over, 2-period, phase III study in male and female subjects with severe non-malignant or malignant pain that requires around-the-clock opioid therapy at a daily dose of 120/60 mg or 160/80 mg oxycodone/naloxone prolonged release (OXN PR).

Eligibility criteria: 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.

Primary outcomes:
measure: (mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale.)
timeFrame: 24 hours at one day in week 2, 3 5 and 6 from date of randomisation.
measure: Equivalent bowel function as assessed by the Bowel Function Index (BFI).
timeFrame: Week 2, 3 5 and 6 from date of randomisation.
Secondary outcomes:
measure: Pain scores of subjects average pain over the last 24 hours and rescue medication use.
timeFrame: Week 1,2,3,4,5 and 6 from date of randomisation
measure: To assess bowel function (assess BFI and laxative use)
timeFrame: Week 1,2,3,4,5 and 6 from date of randomisation
measure: To assess quality of life based on the EuroQol EQ-5D.
timeFrame: Visit 3 and visit 6 from date of randomisation
measure: Number of participants with adverse events, high/low laboratory values and clinically significant ECG findings.
timeFrame: Up to 35 weeks
measure: Pain right now scores at intake of oxycodone/naloxone tablets.
timeFrame: Week 2,3,5 and 6 from date of randomisation
Other outcomes:
Locations:
city: Mainz
country: Germany
Study officials:
References: