Erythemato-Telangiectatic Rosacea (ETR) MedDRA version: 8.1 Level: LLT Classification code 10039218 Term: Rosacea
Conditions
Interventions
Trade Name: Zophren®
Product Name: Ondansetron
Product Code: CD06713
Pharmaceutical Form: Tablet
INN or Proposed INN: Odansetron
CAS Number: 99614-02-5
Current Sponsor code: CD06713
Other descriptive
Sponsors
Galderma Research and Development SNC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 The subject is a male or female adult aged 18 to 65. 2 Subject with moderate to severe ETR characterized by: 2.1 A persistent erythema 2.2 An erythema severity score graded at least 2 on a 5-point scale, on each cheek 2.3 No history of inflammatory (papules and/or pustules) lesions during the past 3 months before inclusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 The subject has a particular form of rosacea (papulopustular rosacea, rhinophyma, severe forms (rosacea conglobata or fulminans), corticosteroids-induced rosacea or isolated pustulosis of the chin), with facial erythrosis of any type (known carcinoid syndrome, dysthyroidism, mastocytosis, serotonin syndrome…) or with peri-oral dermatitis. 2 The subject has an underlying disease, surgical or medical condition, which: 2.1 could interfere with evaluations of the rosacea condition itself (e.g. lupus erythematosis, atopic dermatitis, eczema, acne vulgaris, and psoriasis) 2.2 could put the subject at risk (uncontrolled chronic or serious diseases which would normally prevent participation in any clinical trial, such as a cancer, AIDS, renal or hepatic impairment…) 3 The subject has a facial skin condition which would interfere with study assessments: 3.1 an abnormal pigmentation or skin type IV, V and VI on the Fitzpatrick scale 3.2 a beard or other facial hair 4. The subject has an abnormal ECG. 5. The subject has a past migraine history. 6. The subject is using an antimotility drug (i.e. loperamide). 7. The subject has a past digestive surgical history.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to evaluate the activity of twice daily per os administration of 8mg of CD06713 (ondansetron) over 4 weeks versus placebo in 2 parallel group patients with erythemato-telangiectatic rosacea (ETR).;Secondary Objective: Relapse will be evaluated after a 3-week follow-up period without treatment;Primary end point(s): The primary efficacy variable will be the change from baseline to Week 5 (LOCF, ITT) in combined erythema score (total sum erythema score of the right and left cheek). The change from baseline in the combined Erythema score at Week 5 (ITT, LOCF) and Week 5 (PP) will be analyzed by ANCOVA model including treatment as factor and baseline score as a covariate. Relapse and rebound rates will be analyzed only on those subjects having improved at the end of the treatment period compared to baseline. The rates will be analyzed by a Chi2 test. If at least one theoretical value is <5 fisher’s exact test will be performed. Failure will be assigned in case missing data. An additional analysis for each rate will be also done on Observed cases | — |
Countries
France, Germany
Outcome results
None listed