A Non-interventional, Observational Study for Targinact® Treatment in Patients With Chronic Severe Pain
This study is currently recruiting participants.
Verified October 2012 by Mundipharma CVA
Sponsor:
Mundipharma CVA
Information provided by (Responsible Party):
Mundipharma CVA
ClinicalTrials.gov Identifier:
NCT01710904
First received: October 16, 2012
Last updated: October 22, 2012
Last verified: October 2012
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Purpose
This non-interventional, observational study is set up on request of the Belgian reimbursement authorities and evaluates the efficacy of Targinact with regard to pain relief and constipation in daily clinical practice in Belgium compared to the previous analgesic treatment with prolonged release oxycodone. Only patients eligible for Targinact® reimbursement in Belgium are included.
| Condition | Intervention |
|---|---|
|
Chronic Severe Pain |
Drug: Targinact® (oxycodone/naloxone) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Evaluation of Targinact® in Daily Practice, With Regards to Pain Relief and Constipation, in Chronic Severe Pain Patients Compared to Previous Prolonged Release Oxycodone Treatment: a Non-interventional, Observational Study. |
Resource links provided by NLM:
Further study details as provided by Mundipharma CVA:
Primary Outcome Measures:
- Percentage of responders after Targinact treatment compared to the previous treatment with prolonged release oxycodone. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]A responder is defined as a patient who shows no worsening of pain (pain score has increased ≤ 1 unit on a 11-points pain NRS) at V3/the last visit compared to V1 or has a NRS ≤4 on a 11-points pain NRS at V3/the last visit AND has a reduction in BFI ≥ 12 units at V3/the last visit compared to V1 or has a BFI ≤30 at V3/ the last visit.
Secondary Outcome Measures:
- To assess laxative use during Targinact® treatment compared to previous PR oxycodone treatment (by physician) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]To assess laxative use during Targinact® treatment compared to previous PR oxycodone treatment (by physician)
- To assess the use of analgesic rescue medication during Targinact® treatment compared to previous PR oxycodone treatment (by physician) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]To assess the use of analgesic rescue medication during Targinact® treatment compared to previous PR oxycodone treatment (by physician)
- To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous PR oxycodone treatment (by patient) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous PR oxycodone treatment (by patient)
- To assess safety of Targinact® treatment (by physician) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Safety will be assessed by documentation of adverse events, collected via spontaneous reports and patient documentation.
| Estimated Enrollment: | 125 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
Patients are treated with Targinact® according to daily clinical practice during at least 12 weeks and are monitored during study 3 visits. Parameters assessed are pain relief, constipation, use of laxatives, use of analgesic rescue medication, use of concomitant medication, quality of life and safety of Targinact® treatment. These parameters, except for safety assessment, are compared between Targinact® treatment and previous analgesic treatment with prolonged release oxycodone.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Primary and Secondary Care
Criteria
Inclusion criteria: patients included are patients who
- are eligible for Targinact® treatment according to the Targinact® SPC AND
- who have previously been treated with PR oxycodone during at least the last 30 days before study inclusion AND
- who are constipated (BFI > 30) AND
- have used at least 2 laxatives with different modes of action during the previous PR oxycodone treatment
Exclusion criteria are based on Targinact® SPC.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01710904
Contacts
| Contact: Maggie C Wilson | Info@contact-clinical-trials.com | |
| Contact: Jill Kiteley | Info@contact-clinical-trials.com |
Locations
| Belgium | |
| University Hospital Brussels | Recruiting |
| Brussels, Belgium | |
Sponsors and Collaborators
Mundipharma CVA
More Information
No publications provided
| Responsible Party: | Mundipharma CVA |
| ClinicalTrials.gov Identifier: | NCT01710904 History of Changes |
| Other Study ID Numbers: | OXN9511 |
| Study First Received: | October 16, 2012 |
| Last Updated: | October 22, 2012 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by Mundipharma CVA:
|
Chronic pain Severe pain Oxycodone Naloxone Opioid-induced constipation |
Opioid Quality of life Laxative Analgesic rescue medication |
Additional relevant MeSH terms:
|
Narcotic Antagonists Narcotics Naloxone Oxycodone Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents |
Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Analgesics Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 22, 2013