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Pharmacokinetics, Safety, and Efficacy Trial of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream for the Treatment of Cutaneous Leishmaniasis in Panama

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT01083576
First received: March 8, 2010
Last updated: May 16, 2014
Last verified: May 2014
Results First Received: November 20, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Leishmaniasis, Cutaneous
Interventions: Drug: WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream)
Drug: Paromomycin Alone Cream (15% paromomycin topical cream)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Paromomycin Alone Treatment Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
WR 279,396 WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days

Participant Flow:   Overall Study
    Paromomycin Alone Treatment     WR 279,396  
STARTED     15     15  
COMPLETED     9     14  
NOT COMPLETED     6     1  
Treatment Failure                 6                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset.

Reporting Groups
  Description
Paromomycin Alone Treatment Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
WR 279,396 WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
Total Total of all reporting groups

Baseline Measures
    Paromomycin Alone Treatment     WR 279,396     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age  
[units: years]
Mean ± Standard Deviation
  24.0  ± 16.2     25.5  ± 15.9     24.7  ± 15.8  
Gender  
[units: participants]
     
Female     2     4     6  
Male     13     11     24  
Race/Ethnicity, Customized  
[units: Participants]
     
Mestizo     14     15     29  
Other     1     0     1  
Race/Ethnicity, Customized  
[units: Participants]
     
Hispanic or Latino     15     15     30  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Obtained Final Clinical Cure of Index Lesion   [ Time Frame: 168 days ]

2.  Secondary:   Number of Participants Who Obtained a Modified Final Clinical Cure of All Lesions   [ Time Frame: 168 days ]

3.  Secondary:   Detectable Paromomycin or Gentamicin Plasma Levels   [ Time Frame: 20 days ]

4.  Secondary:   Paromomycin Plasma Concentrations in Adults   [ Time Frame: Day 4 to Day 28 ]

5.  Secondary:   Paromomycin Plasma Concentrations in Children   [ Time Frame: Days 1 and 20 ]

6.  Secondary:   Pharmacokinetic Parameter: Cmax   [ Time Frame: 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 ]

7.  Secondary:   Pharmacokinetic Parameter: Tmax   [ Time Frame: 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 ]

8.  Secondary:   Pharmacokinetic Parameter: Area Under the Curve (AUC)   [ Time Frame: 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 ]

9.  Secondary:   Pharmacokinetic Parameter: t(1/2)   [ Time Frame: 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 ]

10.  Secondary:   Pharmacokinetic Parameter: Cmax/D   [ Time Frame: 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 ]

11.  Secondary:   Pharmacokinetic Parameter: AUC/D   [ Time Frame: Days 1 and 20 ]

12.  Other Pre-specified:   Serum Creatinine Levels   [ Time Frame: Day 1 and Day 20 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There are no PK tables for gentamicin due to low sample size; only 2 individuals with measureable gentamicin.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director, Division of Regulated Activites and Compliance
Organization: US Army Medical Materiel Development Activity (USAMMDA)
phone: 301-619-0197
e-mail: usarmy.detrick.medcom-usammda.mbx.usamrmc-regulatory-affairs@mail.mil


No publications provided by U.S. Army Medical Research and Materiel Command

Publications automatically indexed to this study:

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT01083576     History of Changes
Other Study ID Numbers: PG-PANAMA-08-04; A-15810
Study First Received: March 8, 2010
Results First Received: November 20, 2013
Last Updated: May 16, 2014
Health Authority: United States: Food and Drug Administration
Panama: Commemorative Institute GORGAS of Studies of Health
Panama: Ministry of Health