Who is sponsoring NCT01710904?

NCT01710904 is sponsored by Mundipharma CVA.

What drugs are being tested in NCT01710904?

Interventions in NCT01710904: Targinact® (oxycodone/naloxone).

What condition does NCT01710904 study?

NCT01710904 studies Chronic Severe Pain.

Is NCT01710904 still recruiting?

NCT01710904 is currently completed. Last updated 7 April 2015.

Last reviewed 2015-04-07 · How we verify

NCT01710904

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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.

Completed Last updated 7 April 2015

What this trial tests

trial testing Targinact® (oxycodone/naloxone) in Chronic Severe Pain in 68 participants. Completed in 1 January 2014.

Timeline

1 September 2012

Primary endpoint
1 July 2013

1 January 2014

Quick facts

Lead sponsor	Mundipharma CVA
Status	Completed
Study type	OBSERVATIONAL
Enrollment	68
Start date	1 September 2012
Primary completion	1 July 2013
Estimated completion	1 January 2014
Sites	1 location across Belgium

Drugs / interventions tested

Targinact® (oxycodone/naloxone) — full drug profile →

Conditions studied

Chronic Severe Pain — all drugs for Chronic Severe Pain →

Sponsor

Mundipharma CVA — full company profile →

Who can join

18 and older, any sex, with Chronic Severe Pain. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percentage of responders after Targinact treatment compared to the previous treatment with prolonged release oxycodone.
Time frame: 12 weeks
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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01710904 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mundipharma CVA
Last refreshed: 7 April 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01710904.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing