|
Main
|
|
Note: This record shows only 22 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:
|
19 February 2015 |
|
Main ID: |
NCT01983137 |
|
Date of registration:
|
17/04/2013 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A Non-interventional, Observational Study for Targinact® Treatment in Patients With Severe Pain.
|
|
Scientific title:
|
The Efficacy, With Regard to Pain Relief, of Targinact® Treatment for Patients With Severe Pain Compared to Previous Analgesic Treatment; a Non-interventional Study. |
|
Date of first enrolment:
|
April 2011 |
|
Target sample size:
|
1338 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01983137 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Cohort, Time Perspective: Prospective
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Belgium
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Patients who are to be included in the study, are those who meet all of the following
criteria based on the SPC.
1. Male or female patients at least 18 years, or older, with severe pain.
2. Patients with documented history of severe pain treated with WHO step 1, step 2
and/or 3 analgesics with insufficient pain relief and/or unacceptable side effects
that require around-the-clock opioid therapy and are likely to benefit from WHO step
3 opioid therapy for the duration of the study.
Exclusion criteria are based on the SPC of Targinact®.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Severe Pain
|
|
Intervention(s)
|
|
Drug: Targinact® (oxycodone/naloxone)
|
|
Primary Outcome(s)
|
|
To evaluate the efficacy of Targinact® treatment, with regard to pain relief, in patients with severe pain
[Time Frame: Up to 140 days]
|
|
Secondary Outcome(s)
|
|
The use of laxative medication (yes/no) per 24 hours will be recorded in the e-CRF
[Time Frame: Up to 140 days]
|
|
Bowel Function Index (BFI) will be recorded at each visit
[Time Frame: Up to 140 days]
|
|
Pain NAS score (0-10) will be measured at each visit
[Time Frame: Up to 140 days]
|
|
Efficacy of Targinact® treatment, with regard to bowel function, will be evaluated by the physician (7 categories)
[Time Frame: Up to 140 days]
|
|
The patient's quality of life will be evaluated via the EQ-5D questionnaire
[Time Frame: Up to 140 days]
|
|
The use of analgesic rescue medication (yes/no) used per day (24 hours) will be recorded
[Time Frame: Up to 140 days]
|
|
The patient satisfaction will be evaluated by patient in 7 categories
[Time Frame: Up to 140 days]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|