A Non-interventional, Observational Study for Targinact® Treatment in Patients With Chronic Severe Pain

Chronic Severe Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01710904
• Other study ID #: OXN9511
• Status: Completed
• Phase: N/A
• First received: October 16, 2012
• Last updated: April 7, 2015
• Start date: September 2012
• Est. completion date: January 2014

Study information

• Verified date: April 2015
• Source: Mundipharma CVA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Severe Pain

Intervention

Drug:
• Targinact® (oxycodone/naloxone)

Locations

Country	Name	City	State
Belgium	University Hospital Brussels	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma CVA

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of responders after Targinact treatment compared to the previous treatment with prolonged release oxycodone.	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.	12 weeks	No
Secondary	To assess laxative use during Targinact® treatment compared to previous PR oxycodone treatment (by physician)	To assess laxative use during Targinact® treatment compared to previous PR oxycodone treatment (by physician)	12 weeks	No
Secondary	To assess the use of analgesic rescue medication 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)	12 weeks	No
Secondary	To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous PR oxycodone treatment (by patient)	To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous PR oxycodone treatment (by patient)	12 weeks	No
Secondary	To assess safety of Targinact® treatment (by physician)	Safety will be assessed by documentation of adverse events, collected via spontaneous reports and patient documentation.	12 weeks	No

External Links

•   Clinical Therapeutics