NCT01710917

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 15, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

1.2 years

First QC Date

October 15, 2012

Last Update Submit

November 11, 2013

Conditions

Chronic Severe Pain

Keywords

Chronic painSevere painOxycodonNaloxonOpioid-induced constipationOpioidQuality of lifeLaxativeAnalgesic rescue medication

Outcome Measures

Primary Outcomes (1)

  • Assess the efficacy of Targinact® treatment

    The primary parameter to assess the efficacy of Targinact® treatment with respect to the quality of life (overall health assessment/EQ-VAS) in patients with chronic severe pain compared to previous analgesic treatment is the absolute change in overall health score (0-100) attributed by patients during Targinact® treatment compared to previous analgesic treatment. During each visit, patients will be asked to score their overall health state between 0 (worst health state imaginable) and 100 (best health state imaginable). The absolute changes in overall health assessment from baseline at V2 and V3 will be used to compare health assessment during Targinact® treatment.

    12 weeks

Secondary Outcomes (6)

  • • To assess pain (NRS) during Targinact® treatment compared to previous analgesic treatment (by physician)

    12 weeks

  • To assess constipation (BFI) during Targinact® treatment compared to previous analgesic treatment (by physician)

    12 weeks

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

    12 weeks

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

    12 weeks

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

    12 weeks

  • +1 more secondary outcomes

Study Arms (1)

Targinact® (oxycodon/naloxon)

Drug: Targinact® (oxycodon/naloxon)

Interventions

Targinact® (oxycodon/naloxon)DRUG
Targinact® (oxycodon/naloxon)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary and Secondary care

You may qualify if:

  • Patients enrolled in the study are patients who
  • are eligible for Targinact® treatment according to the Targinact® SPC AND
  • who have previously been treated with WHO step 1, 2 or 3 analgesics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Brussels (UZ Brussel), Belgium

Brussels, Belgium

RECRUITING

Related Publications (1)

  • Poelaert J, Koopmans-Klein G, Dioh A, Louis F, Gorissen M, Loge D, Van Op den Bosch J, van Megen YJ. Treatment with prolonged-release oxycodone/naloxone improves pain relief and opioid-induced constipation compared with prolonged-release oxycodone in patients with chronic severe pain and laxative-refractory constipation. Clin Ther. 2015 Apr 1;37(4):784-92. doi: 10.1016/j.clinthera.2015.02.010. Epub 2015 Mar 7.

    PMID: 25757607DERIVED

MeSH Terms

Conditions

Chronic PainPainOpioid-Induced Constipation

Interventions

oxycodone naloxone combination

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsConstipationSigns and Symptoms, DigestiveNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Maggie C Wilson

CONTACT

Info@contact-clinical-trials.com

Jill Kiteley

CONTACT

Info@contact-clinical-trials.com

Study Design

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

Study Record Dates

First Submitted

October 15, 2012

First Posted

October 19, 2012

Study Start

September 1, 2012

Primary Completion

November 1, 2013

Study Completion

January 1, 2014

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

BE(1)