Women's Mammography Study To Improve Comfort During Mammography

This study has been terminated.
(Lack of funding.)
Sponsor:
Information provided by (Responsible Party):
Kenneth A. Kist,, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01716052
First received: October 18, 2012
Last updated: January 20, 2015
Last verified: January 2015
Results First Received: January 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Pain
Interventions: Drug: placebo
Drug: Ibuprofen

  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
When the woman signs in at the breast imaging clinic desk (on the 5th floor of the Zeller Building at the CTRC), she will be asked if she would speak with the study nurse about this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ibuprofen

Pfizer 200 mg caplets (Advil)

Ibuprofen

Placebo

Lactulose

placebo: Lactulose


Participant Flow:   Overall Study
    Ibuprofen     Placebo  
STARTED     1     1  
COMPLETED     0     0  
NOT COMPLETED     1     1  
Withdrawal of funding                 1                 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.
Two sided significance level of 0.05 and a statistical power of 0.90 with 187 patients in both the placebo and the ibuprofen group..

Reporting Groups
  Description
Ibuprofen

Pfizer 200 mg caplets (Advil)

Ibuprofen

Placebo

Lactulose

placebo: Lactulose

Total Total of all reporting groups

Baseline Measures
    Ibuprofen     Placebo     Total  
Number of Participants  
[units: participants]
  1     1     2  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     1     1     2  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     1     1     2  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     1     1     2  



  Outcome Measures

1.  Primary:   Measure of Discomfort of Mammography   [ Time Frame: 3 years ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Kenneth Kist
Organization: UTHSCSA @CTRC
phone: 210-450-5600
e-mail: KIST@UTHSCSA.EDU


No publications provided


Responsible Party: Kenneth A. Kist,, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01716052     History of Changes
Other Study ID Numbers: CTRC 11-45, HSC20120142H
Study First Received: October 18, 2012
Results First Received: January 13, 2015
Last Updated: January 20, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board