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

Last updated: November 3, 2016
Sponsor: Mundipharma Research GmbH & Co KG
Overall Status: Completed

Phase

2/3

Condition

Cancer Pain

Treatment

N/A

Clinical Study ID

NCT02321397
OXN3508
2013-004888-31
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Total Participants: 155
Study Start date:
November 01, 2014
Estimated Completion Date:
September 30, 2016

Study 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).

Connect with a study center

  • Mainz,
    Germany

    Site Not Available

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