Women's Mammography Study To Improve Comfort During Mammography

Pain Clinical Trial

Official title:

Women's Mammography Study Attempting to Improve the Comfort During Screening Mammography CTRC#11-45

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01716052
• Other study ID #: CTRC 11-45
• Secondary ID: HSC20120142H
• Status: Terminated
• Phase: N/A
• First received: October 18, 2012
• Last updated: December 1, 2015
• Start date: July 2012
• Est. completion date: June 2013

Study information

• Verified date: December 2015
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

This study is designed to evaluate two methods of reducing pain and discomfort caused by mammography, one of the barriers to the procedure.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• placebo
Lactulose
• Ibuprofen

Locations

Country	Name	City	State
United States	Cancer Therapy and Research Center at UTHSCSA	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Kenneth A. Kist,

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of Discomfort of Mammography	The primary outcome measure will be the response to questions on a questionnaire.	3 years	No