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

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.

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Key information

Conditions

Severe Chronic Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gemeinschaftspraxis Loewenstein, Mainz, Germany

About this study

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.

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 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

Treatment and study plan

OXN PR followed by OxyPR tablets

Drug

OxyPR followed by OXN PR tablets

Drug

Primary outcomes

Quantitative analysis of intestinal microbiota as determined in stool samples of subjects treated with OXN PR compared to those treated with OxyPR. As this is an exploratory study, there are no primary objectives, but objectives of main interest.

Time frame: 8 weeks

Composition and abundance of selected bacteria in stool samples by means of genomic sequencing of bacterial genes coding for 16S rRNA will be analysed. The analysis will provide information about intra-individual bacterial profile during the study as well as insights about potential effects of treatments, i.e. OXN PR and OxyPR on bacterial profile.
Orocaecal transit time on the basis of intestinal absorption & intermediary bacterial metabolism by breath tests (H2 and CH4 breath test). As this is an exploratory study, there are no primary objectives, but objectives of main interest.

Time frame: 4 weeks

Orocaecal time will be measured by H2/CH4/ analysis of expired air of subjects (breath tests). The analysis will provide information about intraindividual changes during the study as well as insights about potential effects of treatments, i.e. OXN PR and OxyPR on orocaecal time.

Sponsors and collaborators

Lead sponsor

Mundipharma Research GmbH & Co KG

Industry

Registry information

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Aug 2, 2013
Registry last updated: Dec 14, 2015

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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Completed