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

• Sponsor: Mundipharma Research GmbH & Co KG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02321397
• Collaborator: (none)
• Enrollment: 155
• Location: 1
• Arms: 2
• Duration (Months): 22
• Patients Per Site Per Month: 7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Pain; Non-malignant Pain	Drug: Oxycodone; Drug: Naloxone	Phase 2/Phase 3

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 155 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Nov 1, 2014
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OXN PR HST Prolonged release oxycodone/naloxone higher strength tablets	Drug: Oxycodone
Active Comparator: OXN PR LST Prolonged release oxycodone/naloxone lower strength tablets	Drug: Naloxone; Prolonged Release Tablets

Outcome Measures

Primary Outcome Measures

1. (mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale.) [24 hours at one day in week 2, 3 5 and 6 from date of randomisation.]

   Pain scores based on the mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale. To demonstrate equivalence between multiple lower strength OXN PR tablets and a single higher strength OXN PR tablet taken at the same overall total daily dose

2. Equivalent bowel function as assessed by the Bowel Function Index (BFI). [Week 2, 3 5 and 6 from date of randomisation.]

Secondary Outcome Measures

1. Pain scores of subjects average pain over the last 24 hours and rescue medication use. [Week 1,2,3,4,5 and 6 from date of randomisation]

2. To assess bowel function (assess BFI and laxative use) [Week 1,2,3,4,5 and 6 from date of randomisation]

   To assess BFI and laxative use

3. To assess quality of life based on the EuroQol EQ-5D. [Visit 3 and visit 6 from date of randomisation]

   EuroQol EQ-5D is a standardized instrument for use as a measure of health outcome.

4. Number of participants with adverse events, high/low laboratory values and clinically significant ECG findings. [Up to 35 weeks]

5. Pain right now scores at intake of oxycodone/naloxone tablets. [Week 2,3,5 and 6 from date of randomisation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Mainz		Germany

Sponsors and Collaborators

• Mundipharma Research GmbH & Co KG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mundipharma Research GmbH & Co KG
• ClinicalTrials.gov Identifier: NCT02321397
• Other Study ID Numbers: OXN3508; 2013-004888-31
• First Posted: Dec 22, 2014
• Last Update Posted: Nov 4, 2016
• Last Verified: Dec 1, 2015

• Keywords provided by Mundipharma Research GmbH & Co KG: oxycodone naloxone combination; severe chronic and non-malignant pain; Malignant and non-malignant pain that requires around-the clock opioid therapy
• Additional relevant MeSH terms: Oxycodone; Naloxone

Study Results

No Results Posted as of Nov 4, 2016