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Trial record 1 of 1 for:      Phase II Trial of Sulindac in Individuals at Increased Risk for Melanoma
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Sulindac in Preventing Melanoma in Healthy Participants Who Are at Increased Risk of Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00841204
First received: February 10, 2009
Last updated: May 29, 2014
Last verified: March 2013
Results First Received: February 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Precancerous Condition
Interventions: Drug: sulindac
Other: placebo
Other: laboratory biomarker analysis

  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
Sulindac Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
Placebo Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.

Participant Flow:   Overall Study
    Sulindac     Placebo  
STARTED     25     25  
COMPLETED     25     25  
NOT COMPLETED     0     0  



  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
Sulindac Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
Placebo Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
    Sulindac     Placebo     Total  
Number of Participants  
[units: participants]
  25     25     50  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     25     25     50  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  46.2  ± 10.0     45.9  ± 8.59     46.0  ± 9.24  
Gender  
[units: participants]
     
Female     12     10     22  
Male     13     15     28  
Region of Enrollment  
[units: participants]
     
United States     25     25     50  



  Outcome Measures
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1.  Primary:   Sulindac Concentration in the Nevi (Moles)   [ Time Frame: 8 weeks ]

2.  Primary:   Sulindac Sulfone, an Active Metabolite of Sulindac, Concentration in the Nevi   [ Time Frame: 8 weeks ]

3.  Primary:   Sulindac Sulfide, an Active Metabolite of Sulindac, Concentration in the Nevi   [ Time Frame: 8 weeks ]

4.  Secondary:   Sulindac Effects on Apoptosis in Atypical Nevi   [ Time Frame: 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Sulindac Effects on Vascular Endothelial Growth Factor (VEGF) Expression in Atypical Nevi   [ Time Frame: 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Association Between Plasma and Target Tissue Drug Levels   [ Time Frame: 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
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  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: H-H. Sherry Chow, Ph.D.
Organization: The University of Arizona
phone: 520-626-3358
e-mail: schow@azcc.arizona.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00841204     History of Changes
Other Study ID Numbers: NCI-2009-01115, NCI-2009-01115, UARIZ-08-0841-04, CDR0000633938, N01CN35158, 08-0841-04, UAZ05-2-10, P30CA023074, N01CN35158
Study First Received: February 10, 2009
Results First Received: February 14, 2012
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board