NCT01127906 is a Phase 1 clinical trial of PF-04531083 100mg in Healthy, sponsored by Pfizer.

Who is sponsoring NCT01127906?

NCT01127906 is sponsored by Pfizer.

What drugs are being tested in NCT01127906?

Interventions in NCT01127906: PF-04531083 100mg, PF-04531083 2000mg, Placebo suspension, Placebo tablet, Oxycodone 20mg.

Is NCT01127906 still recruiting?

NCT01127906 is currently completed. Last updated 22 September 2010.

Last reviewed 2010-09-22 · How we verify

NCT01127906

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

A Randomized, Double-Blind, Double-Dummy, Placebo And Active Comparator Controlled 4-Period Cross-Over Study To Assess The Effect Of PF-04531083 On Heat Pain In The UVB-Induced Pain Model In Healthy Volunteers

Completed Phase 1 Last updated 22 September 2010

What this trial tests

Phase 1 trial testing PF-04531083 100mg in Healthy in 36 participants. Completed in 1 September 2010.

Timeline

1 June 2010

Primary endpoint
1 September 2010

1 September 2010

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	basic science
Enrollment	36
Start date	1 June 2010
Primary completion	1 September 2010
Estimated completion	1 September 2010
Sites	1 location across Belgium

Drugs / interventions tested

PF-04531083 100mg — full drug profile →
PF-04531083 2000mg — full drug profile →
Placebo suspension
Placebo tablet
Oxycodone 20mg — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 55, male only, with Healthy. Healthy volunteers can join.

What's being measured

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

To assess the effect of PF-04531083 by using the Heat Pain Tolerance Threshold in the area of UVB-induced erythema (HPTTu) endpoint at 2, 4, 6 and 24 hours.
Time frame: 24 hours

Sponsor's own description

PF-04531083 has been shown to reduce the amount of heat pain experienced by rats with skin that has been sensitized to heat by ultraviolet light. This study is designed to see if this is also true in man.

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 Pfizer 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 NCT01127906 (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 Pfizer
Last refreshed: 22 September 2010

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/NCT01127906.

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