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Women's Mammography Study To Improve Comfort During Mammography

NCT ID: NCT01716052

Last Updated: 2015-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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

Conditions

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Pain

Keywords

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Mammogram Ibuprofen Pain management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ibuprofen

Pfizer 200 mg caplets (Advil)

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Placebo

Lactulose

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Lactulose

Interventions

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placebo

Lactulose

Intervention Type DRUG

Ibuprofen

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kenneth A. Kist,

OTHER

Sponsor Role lead

Responsible Party

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Kenneth A. Kist,

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kenneth Kist, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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Cancer Therapy and Research Center at UTHSCSA

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC20120142H

Identifier Type: OTHER

Identifier Source: secondary_id

CTRC 11-45

Identifier Type: -

Identifier Source: org_study_id