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

NCT01983137 | Completed

• 1 other identifier: OXN9510
• Study Type: observational
• Target: 1,338
• Locations: 1 country
• Sites: 1

Brief Summary

This non-interventional, observational study evaluates the efficacy of Targinact with regard to pain relief in daily clinical practice in Belgium compared to the previous analgesic treatment.

Conditions

Severe Pain

Keywords

Chronic pain; Severe pain; oxycodon; naloxon; opioid-induced constipation; opioid; quality of life; laxative; analgesic rescue medication

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of Targinact® treatment, with regard to pain relief, in patients with severe pain

  Efficacy will be evaluated by the physician (7 categories). For the analysis the ordinal scale will be reduced to a binary scale: responder or non-responder. A responder is defined as a patient responding ''slightly better'', ''better'' or ''much better'' at any time during the Targinact®therapy. A non-responder is defined as a patient responding "same", "slightly worse", "worse", "much worse".

  Up to 140 days

Secondary Outcomes (7)

• Pain NAS score (0-10) will be measured at each visit

  Up to 140 days

• Bowel Function Index (BFI) will be recorded at each visit

  Up to 140 days

• The use of laxative medication (yes/no) per 24 hours will be recorded in the e-CRF

  Up to 140 days

• The use of analgesic rescue medication (yes/no) used per day (24 hours) will be recorded

  Up to 140 days

• Efficacy of Targinact® treatment, with regard to bowel function, will be evaluated by the physician (7 categories)

  Up to 140 days

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: Non-Probability Sample

Study Population

GPs and specialists

You may qualify if:

• Patients who are to be included in the study, are those who meet all of the following criteria based on the SPC.
• Male or female patients at least 18 years, or older, with severe pain.
• 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.

Sponsors & Collaborators

• Mundipharma CVA: lead

Study Sites (1)

University Hospital Antwerp (UZA):

Antwerp, Belgium

Location

MeSH Terms

Conditions

Pain; Chronic 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: April 17, 2013
• First Posted: November 13, 2013
• Study Start: April 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

BE (1)