Skin Diseases, InfectiousPhase 4NCT00343135
AUGMENTIN 1gm In Skin And Soft Tissue Infection
A Phase 4 study testing amoxicillin/clavulanate potassium 1gm in people with Skin Diseases, Infectious and Infection, Soft Tissue, run by GlaxoSmithKline at 3 sites in Pakistan.
Trial summary
Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue infections Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Skin Diseases, Infectious, Infection, Soft Tissue
- What is being tested?
- amoxicillin/clavulanate potassium 1gm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 3 sitesPakistan
- Study dates
- Dec 2004to Mar 2005
- Phase
- Phase 4
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- having diagnosed uncomplicated soft tissue infection (e.g furuncle, cellulitis)
- has given freely documented consent.
Who cannot join
- antibiotics
- have renal or hepatic insufficiency
- systemic toxicity
- pregnancy
- lactation
- hypersensitivity to penicillin or Beta-lactam antibiotics
Trial locations and contacts
3 sites in 1 country.
Pakistan3 sites
GSK Investigational Site
Karachi
GSK Investigational Site
Lahore, 54000
GSK Investigational Site
Lahore
About this study
Official title: An Open, Non-comparative Study to Evaluate the Efficacy and Safety of AUGMENTIN 1gm (875mg Amoxicillin/125mg Clavulanic Acid) po q 12 Hours in the Treatment of Uncomplicated Skin and Soft Tissue Infections in Pakistan
Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue infections
- Conditions
- Skin Diseases, Infectious, Infection, Soft Tissue
- Being tested
- amoxicillin/clavulanate potassium 1gm
- Keywords
- Skin, AUGMENTIN, 1gm, Soft, tissue, Infections
- Medical subject headings
- Skin Diseases, Infectious, Soft Tissue Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amoxicillin/clavulanate potassium 1gmDrug
amoxicillin/clavulanate potassium 1gm
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 | Experimental | Not described Receives: Drug: amoxicillin/clavulanate potassium 1gm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response at 10 - 14 days post therapy
Measured: 10 - 14 days
Secondary outcomes (1)
Clinical response at on-therapy evaluation visit (2 - 4 days following initiation of therapy and 48 - 96 hours post therapy) Bacteriological response at (2 - 4 days following initiation of therapy, 48 - 96 hours post therapy, 10 - 14 days post therapy)
Measured: 2 - 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2006 (estimated)
- Study startDec 2004
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Diseases, InfectiousStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343135
- Sponsor's protocol ID
- 103997
- Status last verified
- Nov 2012
- First submitted
- 20 Jun 2006
- Last updated
- 22 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Non-comparative Study to Evaluate the Efficacy and Safety of AUGMENTIN 1gm (875mg Amoxicillin/125mg Clavulanic Acid) po q 12 Hours in the Treatment of Uncomplicated Skin and Soft Tissue Infections in Pakistan
- ClinicalTrials.gov ID
- NCT00343135
- Acronym / sponsor ID
- 103997
- Conditions
- Skin Diseases, Infectious, Infection, Soft Tissue
- Keywords
- Skin, AUGMENTIN, 1gm, Soft, tissue, Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 22 Jun 2006 (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.
Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue infections
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARM 1 | Experimental | Drug: amoxicillin/clavulanate potassium 1gm |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- having diagnosed uncomplicated soft tissue infection (e.g furuncle, cellulitis)
- has given freely documented consent.
Key exclusion criteria (6 listed)
- antibiotics
- have renal or hepatic insufficiency
- systemic toxicity
- pregnancy
- lactation
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 |
|---|---|---|
| amoxicillin/clavulanate potassium 1gmamoxicillin/clavulanate potassium 1gm | Drug | ARM 1 |
Primary outcome
Clinical response at 10 - 14 days post therapy
Time frame: 10 - 14 days
1 secondary outcome
Clinical response at on-therapy evaluation visit (2 - 4 days following initiation of therapy and 48 - 96 hours post therapy) Bacteriological response at (2 - 4 days following initiation of therapy, 48 - 96 hours post therapy, 10 - 14 days post therapy)
Time frame: 2 - 4 days
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 22 Nov 2012.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing amoxicillin/clavulanate potassium 1gm in people with Skin Diseases, Infectious and Infection, Soft Tissue, run by GlaxoSmithKline at 3 sites in Pakistan.
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 6 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 22 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Pakistan. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 response at 10 - 14 days post therapy (time frame: 10 - 14 days). 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 22 Nov 2012.