Back to resultsA Study to Explore the Influence of Two Opioid Pain Medications on Bacterial Composition in the Gut and Other Gastrointestinal Aspects
Primary Purpose
Severe Chronic Pain
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
OXN PR followed by OxyPR tablets
OxyPR followed by OXN PR tablets
Sponsored by
About this trial
This is an interventional treatment trial for Severe Chronic Pain focused on measuring oxycodone naloxone combination, severe chronic pain, non-malignant pain, Non-malignant pain that requires around-the-clock opioid therapy
Eligibility Criteria
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
Sites / Locations
- Gemeinschaftspraxis Loewenstein
- Dr J Hafer
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
OXN PR followed by OxyPR tablets
OxyPR followed by OXN PR tablets
Arm Description
OXN PR followed by OxyPR tablets
OxyPR followed by OXN PR tablets
Outcomes
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01915147
First Posted
June 6, 2013
Last Updated
December 11, 2015
Sponsor
Mundipharma Research GmbH & Co KG
1. Study Identification
Unique Protocol Identification Number
NCT01915147
Brief Title
A Study to Explore the Influence of Two Opioid Pain Medications on Bacterial Composition in the Gut and Other Gastrointestinal Aspects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma Research GmbH & Co KG
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Chronic Pain
Keywords
oxycodone naloxone combination, severe chronic pain, non-malignant pain, Non-malignant pain that requires around-the-clock opioid therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OXN PR followed by OxyPR tablets
Arm Type
Experimental
Arm Description
OXN PR followed by OxyPR tablets
Arm Title
OxyPR followed by OXN PR tablets
Arm Type
Experimental
Arm Description
OxyPR followed by OXN PR tablets
Intervention Type
Drug
Intervention Name(s)
OXN PR followed by OxyPR tablets
Intervention Type
Drug
Intervention Name(s)
OxyPR followed by OXN PR tablets
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
8 weeks
Title
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.
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Gemeinschaftspraxis Loewenstein
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Facility Name
Dr J Hafer
City
Wetzlar
ZIP/Postal Code
35578
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Study to Explore the Influence of Two Opioid Pain Medications on Bacterial Composition in the Gut and Other Gastrointestinal Aspects
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