|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01438567 |
|
Date of registration:
|
18/08/2011 |
|
Primary sponsor: |
|
|
Public title:
|
A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy
|
|
Scientific 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 |
|
Date of first enrolment:
|
September 2011 |
|
Target sample size:
|
270 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01438567 |
|
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
|
|
|
Countries of recruitment
|
|
Germany
|
United Kingdom
| | | | | | |
|
Contacts
|
|
Name:
|
Magaret C Wilson |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
info@contact-clinical-trials.com |
|
Affiliation:
|
|
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Constipation
|
|
Pain
|
|
Intervention(s)
|
|
Drug: oxycodone prolonged release (OxyPR) tablets
|
|
Drug: oxycodone/naloxone prolonged release (OXN PR) tablets
|
|
Primary Outcome(s)
|
|
Bowel function Index (BFI)
[Time Frame: 5 weeks and a 6 month extension]
|
|
Secondary Outcome(s)
|
|
Pain Intensity Scale (PIS)
[Time Frame: 5 weeks]
|
|
Secondary ID(s)
|
|
2010-021995-27
|
|
OXN3506
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|