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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mundipharma CVA
ClinicalTrials.gov Identifier:
NCT01710904
First received: October 16, 2012
Last updated: November 11, 2013
Last verified: November 2013
  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.


Enrollment: 68
Study Start Date: September 2012
Estimated Study Completion Date: January 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Detailed 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01710904

Locations
Belgium
University Hospital Brussels
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: November 11, 2013
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:
Naloxone
Oxycodone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics

ClinicalTrials.gov processed this record on August 28, 2014