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A Study to Explore the Influence of Two Opioid Pain Medications on Bacterial Composition in the Gut and Other Gastrointestinal Aspects | Clinical Trials | Clareo Health

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A Study to Explore the Influence of Two Opioid Pain Medications on Bacterial Composition in the Gut and Other Gastrointestinal Aspects

NCT01915147•Mundipharma Research GmbH & Co KG

View on ClinicalTrials.gov

Summary

The study is intended to explore changes in the composition and quantity of gut bacteria subject to treatment with strong pain medication. Two pain medications will be compared (OXN PR and OxyPR). Other gastrointestinal parameters will be assessed.

Detailed Description

Patients who require around-the-clock opioid therapy and show symptoms of constipation secondary to opioid treatment will be randomised to receive either OXN PR followed by OxyPR, or vice versa. Each treatment takes 24days. The study is composed of three phases, a pre-randomisation phase, a double-blind phase and a Follow-up phase.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects who are receiving WHO step II/III opioid analgesic medication for the treatment of non-malignant pain and who require daily opioid treatment for pain with WHO step III opioid therapy for the duration of the study, based on Investigator's judgement.
•Documented history of non-malignant pain that requires around-the-clock opioid therapy (20 - 50 mg oxycodone PR equivalent per day for a minimum of study duration).
•Subjects with constipation caused or aggravated by opioids:
•Subject's medical need of regular intake of laxatives to have at least 3 bowel evacuations per week, or having less than 3 bowel evacuations when not taking a laxative.
•In the opinion of the subject and investigator confirm that the subject's constipation is induced, or worsened by the subject's prestudy opioid medication (present at Screening).

Exclusion Criteria

•Any contraindication to oxycodone, naloxone, or any non-investigational medicinal products (NIMPs) that will be used by subjects during the study.
•Continuous systemic use of antibiotics and/or steroids within the last 4 weeks prior to the start of the Screening Period and during the study period.
•Chronic or intermittent pain that results from Fibromyalgia or Rheumatoid Arthritis

Locations (2)

Gemeinschaftspraxis Loewenstein

Mainz, Germany

Dr J Hafer

Wetzlar, Germany

Key Dates

Start Date

July 1, 2013

Primary Completion Date

February 1, 2015

Completion Date

September 1, 2015

Last Updated

December 14, 2015

Enrollment

108

ACTUAL participants

Conditions

Severe Chronic Pain

Interventions

OXN PR followed by OxyPR tablets

DRUG

OxyPR followed by OXN PR tablets

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 14, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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