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

NCT01915147 | Completed Phase 2

• 2 other identifiers: OXN25052012-001772-11
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

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.

Conditions

Severe Chronic Pain

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  8 weeks

• 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.

  4 weeks

Study Arms (2)

OXN PR followed by OxyPR tablets

EXPERIMENTAL

OXN PR followed by OxyPR tablets

Drug: OXN PR followed by OxyPR tablets

OxyPR followed by OXN PR tablets

EXPERIMENTAL

OxyPR followed by OXN PR tablets

Drug: OxyPR followed by OXN PR tablets

Interventions

OXN PR followed by OxyPR tablets DRUG

OXN PR followed by OxyPR tablets

OxyPR followed by OXN PR tablets DRUG

OxyPR followed by OXN PR tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Mundipharma Research GmbH & Co KG: lead

Study Sites (2)

Gemeinschaftspraxis Loewenstein

Mainz, 55116, Germany

Location

Dr J Hafer

Wetzlar, 35578, Germany

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: August 2, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

DE (2)