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| ID | Type | Description | Link |
|---|---|---|---|
| HSC20120142H | Other Identifier | UTHSCSA IRB |
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Lack of funding.
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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.
This study is designed to evaluate two methods of reducing pain and discomfort caused by mammography, one of the barriers to the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen | Active Comparator | Pfizer 200 mg caplets (Advil) |
|
| Placebo | Placebo Comparator | Lactulose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | Lactulose |
| |
| Ibuprofen |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Discomfort of Mammography | The primary outcome measure will be the response to questions on a questionnaire. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Kist, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Therapy and Research Center at UTHSCSA | San Antonio | Texas | 78229 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibuprofen | Pfizer 200 mg caplets (Advil) Ibuprofen |
| FG001 | Placebo | Lactulose placebo: Lactulose |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Two sided significance level of 0.05 and a statistical power of 0.90 with 187 patients in both the placebo and the ibuprofen group..
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibuprofen | Pfizer 200 mg caplets (Advil) Ibuprofen |
| BG001 | Placebo | Lactulose placebo: Lactulose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measure of Discomfort of Mammography | The primary outcome measure will be the response to questions on a questionnaire. | No data was collected or analyzed for the outcome measure because the study was terminated. | Posted | 3 years |
|
|
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Total number of participants at risk is "0" since adverse events were not collected/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibuprofen | Pfizer 200 mg caplets (Advil) Ibuprofen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kenneth Kist | UTHSCSA @CTRC | 210-450-5600 | KIST@UTHSCSA.EDU |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Drug |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo | Lactulose placebo: Lactulose | 0 | 0 | 0 | 0 |
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |