Study Stopped
Lack of funding.
Women's Mammography Study To Improve Comfort During Mammography
Women's Mammography Study Attempting to Improve the Comfort During Screening Mammography CTRC#11-45
2 other identifiers
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pain
Started Jul 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 18, 2012
CompletedFirst Posted
Study publicly available on registry
October 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
January 19, 2015
CompletedDecember 30, 2015
December 1, 2015
11 months
October 18, 2012
January 13, 2015
December 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure of Discomfort of Mammography
The primary outcome measure will be the response to questions on a questionnaire.
3 years
Study Arms (2)
Ibuprofen
ACTIVE COMPARATORPfizer 200 mg caplets (Advil)
Placebo
PLACEBO COMPARATORLactulose
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kenneth A. Kist,lead
Study Sites (1)
Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Kenneth Kist
- Organization
- UTHSCSA @CTRC
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Kist, MD
University of Texas
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 18, 2012
First Posted
October 29, 2012
Study Start
July 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
December 30, 2015
Results First Posted
January 19, 2015
Record last verified: 2015-12