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Safety, Efficacy and Pharmacokinetics (PK) Study of WR 279,396 Versus Paromomycin for Treatment of Cutaneous Leishmaniasis (Peru-PK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT01032382
First received: December 14, 2009
Last updated: August 6, 2014
Last verified: August 2014
Results First Received: June 6, 2014  
Study Type: Interventional
Study Design: Allocation: 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 CL lesions once daily for 20 days
WR 279,396 WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days

Participant Flow:   Overall Study
    Paromomycin Alone Treatment     WR 279,396  
STARTED     16     14  
COMPLETED     11     9  
NOT COMPLETED     5     5  
Disease dissemination                 1                 1  
Treatment failure                 3                 1  
Index lesion relapse                 1                 3  



  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.
No text entered.

Reporting Groups
  Description
Paromomycin Alone Treatment Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
WR 279,396 WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to 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]
  16     14     30  
Age  
[units: years]
Mean ± Standard Deviation
  20.7  ± 16.2     18.2  ± 15.1     19.5  ± 15.5  
Age, Customized  
[units: participants]
     
Adults (18+ years)     5     4     9  
Children (12 to 17 years)     5     3     8  
Children (5 to 11 years)     6     7     13  
Gender  
[units: participants]
     
Female     5     4     9  
Male     11     10     21  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Final Clinical Cure for Index Lesions   [ Time Frame: Initial clinical cure by day 63 and no relapse by day 168 ]

2.  Secondary:   Detectable Paromomycin Plasma Levels   [ Time Frame: Day 4, 7, 12, 17, 20, 28 ]

3.  Secondary:   Paromomycin Plasma Concentrations in Children   [ Time Frame: 0 and 4 hours on days 1 and 20 ]

4.  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 ]

5.  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 ]

6.  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 ]

7.  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 ]

8.  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 ]

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

10.  Secondary:   Final Clinical Cure on All Lesions Independent of Subjects   [ Time Frame: Initial clinical cure by day 63 and no relapse by day 168 ]

11.  Secondary:   Number of Index Lesions Meeting Criteria for Clinical Cure During the Study   [ Time Frame: Day 1, 4, 7, 12, 17, 20, 28, 35, 42, 49, 56, 63, 100, 168 ]


  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
All randomized subjects were included in the mITT analysis. All subjects also met the criteria for the evaluable subset; therefore, no separate analysis of an evaluable subset of subjects was performed.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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: NCT01032382     History of Changes
Other Study ID Numbers: PG-PERU-08-03, A-15809
Study First Received: December 14, 2009
Results First Received: June 6, 2014
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration
Peru: Ethics Committee
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Peru: Instituto Nacional de Salud
Peru: Ministry of Health