Trial Outcomes & Findings for Women's Mammography Study To Improve Comfort During Mammography (NCT NCT01716052)

Results Overview

The primary outcome measure will be the response to questions on a questionnaire.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

3 years

Results posted on

2015-12-30

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Ibuprofen Pfizer 200 mg caplets (Advil) Ibuprofen	Placebo Lactulose placebo: Lactulose
Overall Study STARTED	1	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ibuprofen Pfizer 200 mg caplets (Advil) Ibuprofen	Placebo Lactulose placebo: Lactulose
Overall Study Withdrawal of funding	1	1

Baseline Characteristics

Women's Mammography Study To Improve Comfort During Mammography

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ibuprofen n=1 Participants Pfizer 200 mg caplets (Advil) Ibuprofen	Placebo n=1 Participants Lactulose placebo: Lactulose	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: No data was collected or analyzed for the outcome measure because the study was terminated.

The primary outcome measure will be the response to questions on a questionnaire.

Outcome measures

Outcome data not reported

Adverse Events

Ibuprofen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kenneth Kist

UTHSCSA @CTRC

Phone: 210-450-5600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place