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

Mundipharma

Status and phase: Completed; Phase 2

Conditions: Severe Chronic Pain

Treatments: Drug: OXN PR followed by OxyPR tablets; Drug: OxyPR followed by OXN PR tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT01915147

2012-001772-11 (EudraCT Number)

OXN2505

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

108 participants in 2 patient groups

OXN PR followed by OxyPR tablets

Experimental group

Description:

OXN PR followed by OxyPR tablets

Treatment:

Drug: OXN PR followed by OxyPR tablets

OxyPR followed by OXN PR tablets

Experimental group

Description:

OxyPR followed by OXN PR tablets

Treatment:

Drug: OxyPR followed by OXN PR tablets