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

Sponsor

Mundipharma Research GmbH & Co KG (Industry)

Overall Status

Completed

CT.gov ID

NCT01915147

Collaborator

(none)

108

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Severe Chronic Pain	Drug: OXN PR followed by OxyPR tablets Drug: OxyPR followed by OXN PR tablets	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OXN PR followed by OxyPR tablets OXN PR followed by OxyPR tablets	Drug: OXN PR followed by OxyPR tablets
Experimental: OxyPR followed by OXN PR tablets OxyPR followed by OXN PR tablets	Drug: OxyPR followed by OXN PR tablets

Arm

Intervention/Treatment

Experimental: OXN PR followed by OxyPR tablets

OXN PR followed by OxyPR tablets

Drug: OXN PR followed by OxyPR tablets

Experimental: OxyPR followed by OXN PR tablets

OxyPR followed by OXN PR tablets

Drug: OxyPR followed by OXN PR tablets

Outcome Measures

Primary Outcome Measures

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. [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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gemeinschaftspraxis Loewenstein	Mainz		Germany	55116
2	Dr J Hafer	Wetzlar		Germany	35578

Sponsors and Collaborators

Mundipharma Research GmbH & Co KG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mundipharma Research GmbH & Co KG

ClinicalTrials.gov Identifier:

NCT01915147

Other Study ID Numbers:

OXN2505
2012-001772-11

First Posted:

Aug 2, 2013

Last Update Posted:

Dec 14, 2015

Last Verified:

Dec 1, 2015

Keywords provided by Mundipharma Research GmbH & Co KG

oxycodone naloxone combination

severe chronic pain

non-malignant pain

Non-malignant pain that requires around-the-clock opioid therapy

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Dec 14, 2015