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Study to Assess the Efficacy and Safety of GF-001001-00 Cream in Secondarily-Infected Traumatic Lesions

This study has been completed.
Sponsor:
Information provided by:
Ferrer Internacional S.A.
ClinicalTrials.gov Identifier:
NCT01005771
First received: August 4, 2009
Last updated: June 8, 2010
Last verified: June 2010
  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

Further study details as provided by Ferrer Internacional S.A.:

Primary Outcome Measures:
  • Clinical cure [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005771

Locations
Germany
Dermatologische Praxis
Mahlow, Germany
Sponsors and Collaborators
Ferrer Internacional S.A.
  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 November 27, 2014