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Completed

NCT Number: 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

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.

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Key information

Conditions

Malignant Pain Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Non-malignant Pain Organizing Pneumonia Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mainz, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxycodone

Drug

naloxone

Drug

Prolonged Release Tablets

Primary outcomes

  1. (mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale.)

    Time frame: 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).

    Time frame: Week 2, 3 5 and 6 from date of randomisation.

Secondary outcomes

  1. Pain scores of subjects average pain over the last 24 hours and rescue medication use.

    Time frame: Week 1,2,3,4,5 and 6 from date of randomisation

  2. To assess bowel function (assess BFI and laxative use)

    Time frame: 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.

    Time frame: 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.

    Time frame: Up to 35 weeks

  5. Pain right now scores at intake of oxycodone/naloxone tablets.

    Time frame: Week 2,3,5 and 6 from date of randomisation

Sponsors and collaborators

Lead sponsor

Mundipharma Research GmbH & Co KG

Industry

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 22, 2014
Registry last updated
Nov 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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