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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
  Purpose
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 Intervention
Pain Drug: placebo Drug: Ibuprofen

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Kenneth A. Kist,, The University of Texas Health Science Center at San Antonio:

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


Enrollment: 2
Study Start Date: July 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ibuprofen
Pfizer 200 mg caplets (Advil)
Drug: Ibuprofen
Placebo Comparator: Placebo
Lactulose
Drug: placebo
Lactulose

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.
  Eligibility

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.


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
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
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
United States, Texas
Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Kenneth A. Kist,
Investigators
Principal Investigator: Kenneth Kist, MD University of Texas
  More Information

Responsible Party: Kenneth A. Kist,, Principal Investigator, 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
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:
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