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A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy

NCT01438567 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2018-10-23

No results posted yet for this study

Summary

The primary research objective is to demonstrate that subjects taking OXN PR have improvement in symptoms of constipation as measured by the Bowel Function Index (BFI) compared to subjects taking OxyPR tablets alone with cancer and non-cancer related pain without reducing the effectiveness of pain relief as measured by the Brief Pain Inventory (BPI).

Conditions

Interventions

DRUG

oxycodone/naloxone prolonged release (OXN PR) tablets

Drug: Oxycodone/naloxone prolonged release tablets Arms: OXN PR Dosage: 2x50/25mg daily or 2x60/30mg daily or 2x70/35mg daily or 2x80/40mg daily

DRUG

oxycodone prolonged release (OxyPR) tablets

Drug: Oxycodone prolonged release tablets Arms: OxyPR Dosage: 2x50mg daily or 2x60mg daily or 2x70mg daily or 2x80mg daily

Sponsors & Collaborators

  • Mundipharma Research GmbH & Co KG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-02-28
Completion
2014-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01438567 on ClinicalTrials.gov