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

Non-malignant Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321397
• Other study ID #: OXN3508
• Secondary ID: 2013-004888-31
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 13, 2014
• Last updated: November 3, 2016
• Start date: November 2014
• Est. completion date: September 2016

Study information

• Verified date: December 2015
• Source: Mundipharma Research GmbH & Co KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: BfArMUnited Kingdom: Medicines and Healthcare Products Regulatory AgencySpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: September 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Pain
• Non-malignant Pain

Intervention

Drug:
• Oxycodone

• Naloxone
Prolonged Release Tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Research GmbH & Co KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale.)	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	24 hours at one day in week 2, 3 5 and 6 from date of randomisation.	No
Primary	Equivalent bowel function as assessed by the Bowel Function Index (BFI).		Week 2, 3 5 and 6 from date of randomisation.	No
Secondary	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	No
Secondary	To assess bowel function (assess BFI and laxative use)	To assess BFI and laxative use	Week 1,2,3,4,5 and 6 from date of randomisation	No
Secondary	To assess quality of life based on the EuroQol EQ-5D.	EuroQol EQ-5D is a standardized instrument for use as a measure of health outcome.	Visit 3 and visit 6 from date of randomisation	No
Secondary	Number of participants with adverse events, high/low laboratory values and clinically significant ECG findings.		Up to 35 weeks	Yes
Secondary	Pain right now scores at intake of oxycodone/naloxone tablets.		Week 2,3,5 and 6 from date of randomisation	No