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Women's Mammography Study To Improve Comfort During Mammography

This study has been terminated.
(Lack of funding.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01716052
First Posted: October 29, 2012
Last Update Posted: December 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kenneth A. Kist,, The University of Texas Health Science Center at San Antonio
Results First Submitted: January 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Pain
Interventions: Drug: placebo
Drug: Ibuprofen

  Participant Flow
  Hide Participant Flow

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
No text entered.

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 
Overall Participants Analyzed 
[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



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 ( Other Identifier: UTHSCSA IRB )
First Submitted: October 18, 2012
First Posted: October 29, 2012
Results First Submitted: January 13, 2015
Results First Posted: January 19, 2015
Last Update Posted: December 30, 2015