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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR GENTAMICIN SULFATE

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Clinical Trials for Gentamicin Sulfate

Trial ID Title Status Sponsor Phase Summary
NCT00671528 Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM4) Terminated Merck Sharp & Dohme Corp. Phase 4 This is a parallel-group, randomized, active-controlled, double-blind, Phase 4 trial comparing three creams in the treatment of impetiginous eczema: - Arm A: QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate) - Arm B: Combination of betamethasone diproprionate cream and gentamicin sulfate cream - Arm C: Betamethasone diproprionate cream At 7 sites, in Portugal, a total of 207 subjects will be randomized using a 1:1:1 randomization ratio to receive one of the three possible treatments for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days. Assessments will be made of level of improvement of the target area in each treatment group, number of days for total remission, and safety profile. Note: This study was terminated early due to lack of recruitment (only 3 of the 207 planned participants were enrolled). Statistical analyses were not performed. Further, 7 sites were planned, but only 4 sites were approved out of which 3 sites were initiated.
NCT01878643 Reduction of Bacterial Resistance With Inhaled Antibiotics in the Intensive Care Unit Completed Stony Brook University Phase 0 The purpose of this study was : - to determine the effect of inhaled antibiotics on airway bacteria in ventilated patients - to determine the effect of inhaled antibiotics on respiratory infection
NCT02036528 Safety and Efficacy of Gentamicin Topical Gel (AppliGel-G) for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers Terminated Royer Biomedical, Inc. Phase 1/Phase 2 The purpose of this study is to determine whether AppliGel-G (Gentamicin topical gel) plus oral Ciprofloxacin / Doxycycline are safe and effective in the treatment of mild to moderately infected foot ulcers in diabetic patients.
NCT03012191 Gentamicin Therapy for Recessive Dystrophic Epidermolysis Bullosa Patients With Nonsense Mutations Recruiting University of Southern California Phase 1/Phase 2 Recessive dystrophic epidermolysis bullosa (RDEB) is an incurable, devastating, inherited skin disease caused by mutations in the COL7A1 gene that encodes for type VII collagen (C7), the major component of anchoring fibrils (AFs), structures that mediate epidermal-dermal adherence. Thirty percent of RDEB patients have nonsense mutations. The investigators recently demonstrated in 5 such patients that intradermal and topical gentamicin induced "read-through" of their nonsense mutations and created robust and sustained new C7 and AFs at the dermal-epidermal junction (DEJ) of their skin and also stimulated wound closure and reduced new blister formation. No untoward side effects occurred. Herein, the investigators propose evaluating the safety and efficacy of intravenous gentamicin in these patients. In theory, this intravenous administration has the possibility of treating simultaneously all of the patients' skin wounds. The investigators also propose optimizing the concentration and manner of delivery of topical gentamicin. The unambiguous milestones will be increased C7 and AFs in the patients' DEJ, improved EB Disease Activity Scores, and absence of significant gentamicin side effects.
NCT03299452 Clinical Studies by Using Accelerated PDX Model to Screen Drugs for Advanced Solid Tumor Recruiting Haining Health-Coming Biotech Co., Ltd. Phase 2 This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS,safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on the accelerated PDX model screening in subjects with advanced malignant tumor.
NCT03492866 Efficacy of Topical Gentamycin for Hereditary Hypotrichosis Simplex Caused by Nonsense Mutations in CDSN Not yet recruiting Tel-Aviv Sourasky Medical Center Phase 2 The scalp-limited for of hereditary hypotrichosis simplex (HHS; MIM146520) is an autosomal dominant form of non-syndromic alopecia which is caused by heterozygous nonsense mutations in the CDSN gene, encoding corneodesmosin (1). The disease features diffuse gradual scalp hair loss that starts in the middle of the first decade of life and progresses to total alopecia till the third decade of life. Recent studies have shown that aminoglycosides have the potential to induce readthrough of nonsense mutations in human cells. The aim of this study is to investigate whether topical aminoglycosides (Gentamycin) may be beneficial for the treatment of HHS patients carrying nonsense mutations by inducing readthrough. The Study goals: To assess the short and long term efficacy of topical gentamycin for the treatment of hereditary hypotrichosis simplex caused by nonsense heterozygous mutations in CDSN. The primary end point: To assess scalp hair growth during study period as compared to baseline. Hair growth will be evaluated during enrollment and every 4 weeks. The secondary end points will be time to regrowth for determining efficacy.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Gentamicin Sulfate

Condition Name

Condition Name for Gentamicin Sulfate
Intervention Trials
Eczema, Atopic 1
Respiratory Failure 1
Diabetic Foot Ulcers 1
Recessive Dystrophic Epidermolysis Bullosa 1
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Condition MeSH

Condition MeSH for Gentamicin Sulfate
Intervention Trials
Epidermolysis Bullosa 2
Dermatitis, Atopic 1
Wounds and Injuries 1
Diabetic Foot 1
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Clinical Trial Locations for Gentamicin Sulfate

Trials by Country

Trials by Country for Gentamicin Sulfate
Location Trials
United States 10
China 1
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Trials by US State

Trials by US State for Gentamicin Sulfate
Location Trials
Michigan 2
California 2
Maryland 1
Georgia 1
Florida 1
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Clinical Trial Progress for Gentamicin Sulfate

Clinical Trial Phase

Clinical Trial Phase for Gentamicin Sulfate
Clinical Trial Phase Trials
Phase 4 1
Phase 2/Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Gentamicin Sulfate
Clinical Trial Phase Trials
Recruiting 3
Terminated 2
Not yet recruiting 2
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Clinical Trial Sponsors for Gentamicin Sulfate

Sponsor Name

Sponsor Name for Gentamicin Sulfate
Sponsor Trials
University of Southern California 2
Stony Brook University 1
Merck Sharp & Dohme Corp. 1
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Sponsor Type

Sponsor Type for Gentamicin Sulfate
Sponsor Trials
Other 6
Industry 2
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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Covington
US Army
Federal Trade Commission
Baxter
McKinsey
QuintilesIMS
Chubb
Medtronic

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