NCT01304069 is a Phase 1 clinical trial of Selecoxib in Healthy, sponsored by Turku University Hospital.

Who is sponsoring NCT01304069?

NCT01304069 is sponsored by Turku University Hospital.

What drugs are being tested in NCT01304069?

Interventions in NCT01304069: Placebo, Selecoxib, Etoricoxib.

Is NCT01304069 still recruiting?

NCT01304069 is currently completed. Last updated 8 July 2011.

Last reviewed 2011-07-08 · How we verify

NCT01304069

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

Effect of Celecoxib and Etoricoxib on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol

Completed Phase 1 Last updated 8 July 2011

What this trial tests

Phase 1 trial testing Placebo in Healthy in 12 participants. Completed in 1 July 2011.

Timeline

1 January 2011

Primary endpoint
1 July 2011

1 July 2011

Quick facts

Lead sponsor	Turku University Hospital
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	12
Start date	1 January 2011
Primary completion	1 July 2011
Estimated completion	1 July 2011
Sites	1 location across Finland

Drugs / interventions tested

Placebo
Selecoxib — full drug profile →
Etoricoxib (ETORICOXIB) — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Turku University Hospital

Who can join

Adults 18 to 40, any sex, with Healthy. Healthy volunteers can join.

What's being measured

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

Concentration of tramadol and its metabolites in plasma
Time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours after administration of tramadol

Sponsor's own description

Tramadol is an opioid analgesic, which is widely used in the treatment of acute and neuropathic pain. After oral administration, tramadol is rapidly and almost completely absorbed. Tramadol is extensively metabolised by O- and N-demethylation, which are catalysed by the liver CYP-450 enzymes. O-desmethyltramadol is an active metabolite and its formation is catalysed by CYP2D6. This study is aimed to investigate the possible interaction of oral tramadol with selecoxib and etoricoxib. Selecoxib is known to inhibit CYP2D6. Twelve healthy male or female adult non-smoking volunteers aged 18-40 years with body weights within ±15% of the ideal weight for height are taken into the study. Primary endpoints of the study are plasma concentrations of tramadol and its metabolites.

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:

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Other Turku University Hospital trials

Trials by the same sponsor.

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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 NCT01304069 (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 Turku University Hospital
Last refreshed: 8 July 2011

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/NCT01304069.

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