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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

NCT ID: NCT01915147

Last Updated: 2015-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Severe Chronic Pain

Keywords

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oxycodone naloxone combination severe chronic pain non-malignant pain Non-malignant pain that requires around-the-clock opioid therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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OXN PR followed by OxyPR tablets

OXN PR followed by OxyPR tablets

Group Type EXPERIMENTAL

OXN PR followed by OxyPR tablets

Intervention Type DRUG

OxyPR followed by OXN PR tablets

OxyPR followed by OXN PR tablets

Group Type EXPERIMENTAL

OxyPR followed by OXN PR tablets

Intervention Type DRUG

Interventions

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OXN PR followed by OxyPR tablets

Intervention Type DRUG

OxyPR followed by OXN PR tablets

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mundipharma Research GmbH & Co KG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gemeinschaftspraxis Loewenstein

Mainz, , Germany

Site Status

Dr J Hafer

Wetzlar, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2012-001772-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

OXN2505

Identifier Type: -

Identifier Source: org_study_id