Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02321397
Recruitment Status : Completed
First Posted : December 22, 2014
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
Mundipharma Research GmbH & Co KG

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : November 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321397


Locations
Layout table for location information
Germany
Mainz, Germany
Sponsors and Collaborators
Mundipharma Research GmbH & Co KG

Layout table for additonal information
Responsible Party: Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier: NCT02321397     History of Changes
Other Study ID Numbers: OXN3508
2013-004888-31 ( EudraCT Number )
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: December 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:
Layout table for MeSH terms
Oxycodone
Naloxone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Narcotic Antagonists