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Women's Mammography Study To Improve Comfort During Mammography

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.
 
ClinicalTrials.gov Identifier: NCT01716052
Recruitment Status : Terminated (Lack of funding.)
First Posted : October 29, 2012
Results First Posted : January 19, 2015
Last Update Posted : December 30, 2015
Sponsor:
Information provided by (Responsible Party):
Kenneth A. Kist,, The University of Texas Health Science Center at San Antonio

Study Description
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Brief Summary:
The purpose of this study is to determine in a randomized trial whether it is possible to decrease the discomfort of mammography by using the analgesic ibuprofen, or by using a scripted, supportive text informing patients about mammography.

Condition or disease Intervention/treatment Phase
Pain Drug: placebo Drug: Ibuprofen Not Applicable

Detailed Description:
This study is designed to evaluate two methods of reducing pain and discomfort caused by mammography, one of the barriers to the procedure.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Women's Mammography Study Attempting to Improve the Comfort During Screening Mammography CTRC#11-45
Study Start Date : July 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Ibuprofen
Pfizer 200 mg caplets (Advil)
 Drug: Ibuprofen
Placebo Comparator: Placebo
Lactulose
 Drug: placebo
Lactulose


Outcome Measures
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Primary Outcome Measures :
  1. Measure of Discomfort of Mammography [ Time Frame: 3 years ]
    The primary outcome measure will be the response to questions on a questionnaire.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must have signed the informed consent.
  • Must either be getting her first mammogram or based on prior experience be expecting level 4 or 5 pain

Exclusion Criteria:

  • May not have taken ibuprofen or other pain medication within the last 12 hours.
  • Must not have a contraindication for taking ibuprofen e.g:
  • No history of allergic reactions to ibuprofen or aspirin
  • No recent history with the last year of bleeding from GI tract
  • Not pregnant or suspected of being pregnant
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716052


Locations
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United States, Texas
Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Kenneth A. Kist,
Investigators
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Principal Investigator: Kenneth Kist, MD University of Texas
More Information
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Responsible Party: Kenneth A. Kist,, Principal Investigator, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01716052    
Other Study ID Numbers: CTRC 11-45
HSC20120142H ( Other Identifier: UTHSCSA IRB )
First Posted: October 29, 2012    Key Record Dates
Results First Posted: January 19, 2015
Last Update Posted: December 30, 2015
Last Verified: December 2015
Keywords provided by Kenneth A. Kist,, The University of Texas Health Science Center at San Antonio:
Mammogram
Ibuprofen
Pain management
Additional relevant MeSH terms:
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Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action