Study to Assess the Efficacy and Safety of GF-001001-00 Cream in Secondarily-Infected Traumatic Lesions
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Purpose
This is a double-blind, randomized, placebo-controlled, parallel-group, dose-finding study.
| Condition | Intervention | Phase |
|---|---|---|
|
Secondarily Infected Traumatic Lesions |
Drug: GF-001001-00 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | GF-001001-00 Cream.A Multicentre, Randomised, Double-blind, Parallel, Placebo-controlled Phase II Study to Assess the Efficacy and Safety of 3 Different Doses of GF-001001-00 Cream Versus Placebo Cream Applied 2 Times Daily for 7 Days in the Treatment of Adult Patients With Secondarily-infected Traumatic Lesions |
- Clinical cure [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
- Microbiological cure [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]
- Adverse events Clinical laboratory parameters Vital signs [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]
| Enrollment: | 200 |
| Study Start Date: | September 2009 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: GF-001001-00 2% |
Drug: GF-001001-00
GF-001001-00 2%, 1% and 0.25% twice daily for 7 days
|
| Experimental: GF-001001-00 1% |
Drug: GF-001001-00
GF-001001-00 2%, 1% and 0.25% twice daily for 7 days
|
| Experimental: GF-001001-00 0.25% |
Drug: GF-001001-00
GF-001001-00 2%, 1% and 0.25% twice daily for 7 days
|
| Placebo Comparator: Placebo |
Drug: Placebo
Matching placebo
|
Detailed Description:
200 eligible patients will be included in the double-blind phase (50 in each group, randomised 1:1:1:1 to GF-001001-00 at a concentration of 0.25%, 1% or 2% or placebo).
Randomised patients will apply the study medication as follows depending on their assigned treatment group.
- GF-001001-00 2%, 2 times daily, for 7 days
- GF-001001-00 1%, 2 times daily, for 7 days
- GF-001001-00 0.25%, 2 times daily, for 7 days
- Placebo, 2 times daily, for 7 days
The first application will be done after randomisation at Visit 1 under the guidance of the investigator. Patients will return for control visits: Visit 2 (Day 5) and Visit 3 (Day 7), after randomisation. Patients will return for the Final Visit (Visit 4, Day 14 after initiation of treatment).
Primary objective:
To determine the most effective dose of GF-001001-00 cream for treatment of adult patients with secondarily infected traumatic lesions.
Primary efficacy endpoint:
Clinical response (success or failure) at the Final Visit (Day 14) in the ITTC population.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males and females ≥ 18 years of age.
- Presence of small laceration, sutured wound, abrasion or burn, which has a secondary bacterial infection.
Exclusion Criteria:
- None.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Nuria Albareda, Ferrer Internacional S.A. |
| ClinicalTrials.gov Identifier: | NCT01005771 History of Changes |
| Other Study ID Numbers: | P-080623-01 |
| Study First Received: | August 4, 2009 |
| Last Updated: | June 8, 2010 |
| Health Authority: | Spain: Spanish Agency of Medicines France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Ministry of Health Czech Republic: State Institute for Drug Control Poland: Ministry of Health |
Keywords provided by Ferrer Internacional S.A.:
|
Secondarily infected traumatic lesions |
ClinicalTrials.gov processed this record on May 21, 2013