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Assess the Efficacy and Safety in Volunteers of DCF100, TIB200 and SPR300 vs. Placebo and Control(s) in a UV Pain Model

NCT02666846 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-01-27

Study results available
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Summary

This is a randomised, double blind, cross over clinical study in healthy human volunteers (including pharmacokinetic \[PK\] sampling and laser Doppler assessment of local blood flow in a subset of up to 6 subjects per cohort of 20) to assess the efficacy and safety of three different topical analgesics (DCF100, TIB200 and SPR300) versus placebo and active control(s) in a model of UV-induced inflammatory pain.

Conditions

Interventions

DRUG

Ibuprofen

DRUG

Diclofenac

DRUG

Methyl-salicylate / Menthol

DRUG

Placebo

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Futura Medical Developments Ltd.

    lead INDUSTRY

Principal Investigators

  • Annelize Koch, MBChB · PAREXEL Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02666846 on ClinicalTrials.gov