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

NCT01710904 | Completed

• 1 other identifier: OXN9511
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Severe Pain

Keywords

Chronic pain; Severe pain; Oxycodone; Naloxone; Opioid-induced constipation; Opioid; Quality of life; Laxative; Analgesic rescue medication

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• To assess laxative use during Targinact® treatment compared to previous PR oxycodone treatment (by physician)

  12 weeks

• To assess the use of analgesic rescue medication during Targinact® treatment compared to previous PR oxycodone treatment (by physician)

  12 weeks

• To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous PR oxycodone treatment (by patient)

  12 weeks

• To assess safety of Targinact® treatment (by physician)

  12 weeks

Interventions

Targinact® (oxycodone/naloxone) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary and Secondary Care

You may qualify if:

• are eligible for Targinact® treatment according to the Targinact® SPC AND
• who are constipated (BFI \> 30) AND
• have used at least 2 laxatives with different modes of action during the previous PR oxycodone treatment

Sponsors & Collaborators

• Mundipharma CVA: lead

Study Sites (1)

University Hospital Brussels

Brussels, Belgium

Location

Related Links

• Clinical Therapeutics

MeSH Terms

Conditions

Chronic Pain; Pain; Opioid-Induced Constipation

Interventions

oxycodone naloxone combination; Oxycodone; Naloxone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Constipation; Signs and Symptoms, Digestive; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 19, 2012
• Study Start: September 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: January 1, 2014
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

BE (1)