Secondarily Infected Traumatic LesionsPhase 2NCT01005771
Study to Assess the Efficacy and Safety of GF-001001-00 Cream in Secondarily-Infected Traumatic Lesions
A Phase 2 study testing GF-001001-00 in people with Secondarily Infected Traumatic Lesions, run by Ferrer Internacional S.A. at 1 site in Germany.
Trial summary
This is a double-blind, randomized, placebo-controlled, parallel-group, dose-finding study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondarily Infected Traumatic Lesions
- What is being tested?
- GF-001001-00
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2009to Mar 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years of age.
- Presence of small laceration, sutured wound, abrasion or burn, which has a secondary bacterial infection.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
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
This is a double-blind, randomized, placebo-controlled, parallel-group, dose-finding study.
Read the 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.
- Conditions
- Secondarily Infected Traumatic Lesions
- Being tested
- GF-001001-00, Placebo
- Keywords
- Secondarily infected traumatic lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GF-001001-00Drug
GF-001001-00 2%, 1% and 0.25% twice daily for 7 days
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| GF-001001-00 2% | Experimental | Not described Receives: Drug: GF-001001-00 |
| GF-001001-00 1% | Experimental | Not described Receives: Drug: GF-001001-00 |
| GF-001001-00 0.25% | Experimental | Not described Receives: Drug: GF-001001-00 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure
Measured: Day 14
Secondary outcomes (2)
Microbiological cure
Measured: Day 14
Adverse events Clinical laboratory parameters Vital signs
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondarily Infected Traumatic LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferrer Internacional S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005771
- Sponsor's protocol ID
- P-080623-01
- Status last verified
- Jun 2010
- First submitted
- 4 Aug 2009
- Last updated
- 9 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01005771
- Acronym / sponsor ID
- P-080623-01
- Conditions
- Secondarily Infected Traumatic Lesions
- Keywords
- Secondarily infected traumatic lesions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ferrer Internacional S.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 2 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind, randomized, placebo-controlled, parallel-group, dose-finding study.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GF-001001-00 2% | Experimental | Drug: GF-001001-00 |
| GF-001001-00 1% | Experimental | Drug: GF-001001-00 |
| GF-001001-00 0.25% | Experimental | Drug: GF-001001-00 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females ≥ 18 years of age.
- Presence of small laceration, sutured wound, abrasion or burn, which has a secondary bacterial infection.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GF-001001-00GF-001001-00 2%, 1% and 0.25% twice daily for 7 days | Drug | GF-001001-00 0.25%, GF-001001-00 1%, GF-001001-00 2% |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
Clinical cure
Time frame: Day 14
2 secondary outcomes
Microbiological cure
Time frame: Day 14
Adverse events Clinical laboratory parameters Vital signs
Time frame: Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GF-001001-00 in people with Secondarily Infected Traumatic Lesions, run by Ferrer Internacional S.A. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2010.