PainNCT01716052
Women's Mammography Study To Improve Comfort During Mammography
A study testing Ibuprofen in people with Pain, run by Kenneth A. Kist, at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Ibuprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, 78229
About this study
Official title: Women's Mammography Study Attempting to Improve the Comfort During Screening Mammography CTRC#11-45
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.
Read the detailed description
This study is designed to evaluate two methods of reducing pain and discomfort caused by mammography, one of the barriers to the procedure.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Lactulose
IbuprofenDrug
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Active comparator | Pfizer 200 mg caplets (Advil) Receives: Drug: Ibuprofen |
| Placebo | Placebo comparator | Lactulose Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Discomfort of Mammography
The primary outcome measure will be the response to questions on a questionnaire.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: Lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenneth A. Kist,
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kenneth A. Kist,, The University of Texas Health Science Center at San Antonio
- Investigators
- Kenneth Kist, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716052
- Sponsor's protocol ID
- CTRC 11-45
- Other IDs
- HSC20120142H
- Status last verified
- Dec 2015
- First submitted
- 18 Oct 2012
- Last updated
- 30 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Mammography Study Attempting to Improve the Comfort During Screening Mammography CTRC#11-45
- ClinicalTrials.gov ID
- NCT01716052
- Acronym / sponsor ID
- CTRC 11-45
- Conditions
- Pain
- Keywords
- Mammogram, Ibuprofen, Pain management
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Kenneth A. Kist,University, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 Oct 2012 (estimated)
- Results
- Posted 19 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
This study is designed to evaluate two methods of reducing pain and discomfort caused by mammography, one of the barriers to the procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Active comparator | Drug: IbuprofenPfizer 200 mg caplets (Advil) |
| Placebo | Placebo comparator | Drug: placeboLactulose |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboLactulose | Drug | Placebo |
| Ibuprofen | Drug | Ibuprofen |
Primary outcome
Measure of Discomfort of Mammography
Time frame: 3 years
The primary outcome measure will be the response to questions on a questionnaire.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Kist, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen in people with Pain, run by Kenneth A. Kist, at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of Discomfort of Mammography (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2015.