A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy
This study is currently recruiting participants.
Verified May 2012 by Mundipharma Research GmbH & Co KG
Sponsor:
Mundipharma Research GmbH & Co KG
Information provided by (Responsible Party):
Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier:
NCT01438567
First received: August 18, 2011
Last updated: May 17, 2012
Last verified: May 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Constipation |
Drug: oxycodone/naloxone prolonged release (OXN PR) tablets Drug: oxycodone prolonged release (OxyPR) tablets |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomised, Double-blind, Double-dummy, Parallel-group Multicenter Study to Demonstrate Improvement in Symptoms of Constipation and Non-inferiority in Analgesic Efficacy in Subjects With Non-malignant or Malignant Pain That Require Around-the-clock Opioid Therapy Taking 50/25 - 80/40 mg Twice Daily as Oxycodone/Naloxone Prolonged Release (OXN PR) Tablets Compared to Subjects Taking 50 - 80 mg Twice Daily Oxycodone Prolonged Release (OxyPR) Tablets Alone |
Resource links provided by NLM:
Further study details as provided by Mundipharma Research GmbH & Co KG:
Primary Outcome Measures:
- Bowel function Index (BFI) [ Time Frame: 5 weeks and a 6 month extension ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- Pain Intensity Scale (PIS) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]To demonstrate non-inferiority of OXN PR compared to OxyPR with respect to the analgesic efficacy based on the subjects' 'Average Pain over last 24 Hours' assessed at each Double-blind Phase visit as measured by the Pain Intensity Scale.
| Estimated Enrollment: | 270 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: OXN PR tablets |
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
|
| Active Comparator: OxyPR tablets |
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
|
Detailed Description:
The study OXN3506 is a multicentre, multiple-dose, randomised, double-blind, double-dummy, active-controlled, parallel-group study in male and female subjects with non-malignant or malignant pain requiring opioids to assess analgesic efficacy and symptoms of constipation secondary to opioid treatment. Subjects will be randomised to two treatment groups and will be treated with OXN PR or OxyPR for up to 5 weeks. The study is composed of three phases, a pre-randomisation phase, a double-blind phase and an extension phase.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
- Subjects who are receiving WHO step III opioid analgesic medication for the treatment of non-malignant or malignant pain.
- Documented history of non-malignant or malignant pain that requires around-the-clock opioid therapy
Exclusion Criteria
- Females who are pregnant or lactating.
- Subjects with evidence or significant structural abnormalities of the gastrointestinal tract.
- Subjects with evidence of impaired liver/kidney function upon entry into the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438567
Contacts
| Contact: Magaret C Wilson | info@contact-clinical-trials.com | |
| Contact: Jill Kiteley | info@contact-clinical-trials.com |
Locations
| United Kingdom | |
| Ballygomartin Group Practice | Recruiting |
| Belfast, United Kingdom | |
Sponsors and Collaborators
Mundipharma Research GmbH & Co KG
More Information
No publications provided
| Responsible Party: | Mundipharma Research GmbH & Co KG |
| ClinicalTrials.gov Identifier: | NCT01438567 History of Changes |
| Other Study ID Numbers: | OXN3506, 2010-021995-27 |
| Study First Received: | August 18, 2011 |
| Last Updated: | May 17, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Mundipharma Research GmbH & Co KG:
|
oxycodone naloxone combination severe chronic and non-malignant pain Malignant and non-malignant pain that requires around-the clock opioid therapy Opioid related constipation |
Additional relevant MeSH terms:
|
Constipation Signs and Symptoms, Digestive Signs and Symptoms Naloxone Oxycodone Analgesics, Opioid Narcotic Antagonists Physiological Effects of Drugs |
Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Narcotics Central Nervous System Depressants Analgesics |
ClinicalTrials.gov processed this record on May 19, 2013