NCT01055249

Brief Summary

Single centre, subject and observer blinded, placebo controlled, cross-over study of the effect of oral ibuprofen and topical hydrocortisone-21-acetate on ultraviolet radiation (UVR) induced pain and inflammation in healthy volunteers conducted in two segments and using an intra-individual comparison of application areas.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 pain

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Last Updated

July 13, 2010

Status Verified

July 1, 2010

Enrollment Period

5 months

First QC Date

January 22, 2010

Last Update Submit

July 12, 2010

Conditions

PainInflammationHealthy Volunteers

Keywords

UVBpaininflammationmodelhealthy volunteersUltraviolet radiation (UVR) induced pain and inflammation in healthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Hyperalgesia to heat

    72 h

Secondary Outcomes (1)

  • Erythema, Skin temperature

    72 h

Study Arms (2)

Group A

OTHER

Ibuprofen 600 mg (active comparator); Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator)

Drug: Ibuprofen, Hydrocortisone

Group B

OTHER

Oral Placebo (placebo comparator), Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator)

Drug: Hydrocortisone

Interventions

Ibuprofen, HydrocortisoneDRUG

Ibuprofen 600 mg film coated tablets, b.i.d., Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.

Group A
HydrocortisoneDRUG

Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.

Group B

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

X-pert Med GmbH

Gräfelfing, Bavaria, 82166, Germany

Location

MeSH Terms

Conditions

PainInflammation

Interventions

IbuprofenHydrocortisone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 22, 2010

First Posted

January 25, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Last Updated

July 13, 2010

Record last verified: 2010-07

Locations

DE(1)