Breast PainPhase 2/3NCT00276419
Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin
A Phase 2/3 study testing Diclofenac in people with Breast Pain and Non-cyclical Mastalgia, run by Mayo Clinic at 1 site in United States.
Trial summary
The study was a randomized, double-blinded, crossover trial of topical diclofenac and placebo (10 weeks of each) for the treatment of noncyclic breast pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Pain, Non-cyclical Mastalgia, Surgical Scar-Related Breast Pain
- What is being tested?
- Diclofenac
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to May 2009
- Phase
- Phase 2/3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Noncyclic mastalgia or surgical scar-related pain occurring at least 2 days per week and for which the patient desires treatment
- Duration of pain > 2 months (noncyclic mastalgia) or > 4 months (surgical scar-related pain)
- Age > 18 years
- Satisfactory breast examination and directed ultrasound at site of pain (all ages) within 12 months
- Satisfactory mammogram (all women > 30 years of age) within 12 months
- Negative pregnancy test (all women who are premenopausal and have not had hysterectomy or tubal ligation)
Who cannot join
- Cyclic mastalgia (as defined above)
- Duration of pain > 2 months (noncyclic mastalgia) or > 4 months (surgical scar-related pain)
- Abnormal breast examination or imaging (abnormality at the site of pain or for which biopsy or surgical consultation is recommended)
- Known pregnancy, lactation, positive pregnancy test, or anticipated pregnancy within 6 months
- Asthma, that has been aggravated by oral nonsteroidal antiinflammatory agents
- Allergy, to diclofenac or any nonsteroidal antiinflammatory agents
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- Rash or open lesions at the site on the breast where the topical agent would be applied
- Incomplete or abnormal healing (surgical scar-related pain)
- History of gastrointestinal ulceration, renal dysfunction (creatinine > 1.5), hepatic disease (known liver disease or aspartate aminotransferase (AST) twice normal levels), congestive heart failure and uncontrolled hypertension (blood pressure > 140/90)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Diclofenac for the Treatment of Noncyclic Breast Pain
The study was a randomized, double-blinded, crossover trial of topical diclofenac and placebo (10 weeks of each) for the treatment of noncyclic breast pain.
Read the detailed description
A prospective, randomized, double-blinded crossover trial comparing topical diclofenac and placebo for 10 weeks in the treatment of 30 women with noncyclic mastalgia and surgical scar-related breast pain.
- Being tested
- Diclofenac, Placebo
- Medical subject headings
- Mastodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiclofenacDrug
Also called Cambia, Cataflam, Voltaren, Voltarol
Compounded topical diclofenac cream applied to the skin three times daily for 10 weeks
PlaceboDrug
Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo First, then Diclofenac (Arm A) | Experimental | Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks. Receives: Drug: Diclofenac; Drug: Placebo |
| Diclofenac First, then Placebo (Arm B) | Experimental | Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks. Receives: Drug: Diclofenac; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Breast Pain
Participants will complete a breast pain diary indicating the sensation of pain on a daily basis. The frequency of breast pain will be determined by the number of days per week that the subject recorded experiencing pain at 4 weeks and 10 weeks of each treatment.
Measured: 4 weeks, 10 weeks
Severity of Breast Pain
Severity will measured using a 100 mm visual analog scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain severity VAS, 0 means no pain and 100 means extreme pain. The investigator measures the written mark of the participant in mm, and records this for the value of pain severity. The severity of breast pain will be determined by the mean of breast pain scores (determined for all days and for days for which pain is greater than 0) at 4 weeks and 10 weeks of each treatment.
Measured: 4 weeks, 10 weeks
Secondary outcomes (1)
Mean Days of Pain During the 10 Week Treatment Periods
Participants will complete a breast pain diary indicating the sensation of pain on a daily basis. Mean number of days with pain during each 10 week treatment period will be calculated.
Measured: Approximately 12 weeks and at 24 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startJun 2005
- Primary completionMay 2009
- Study completionMay 2009
Why it stopped: Lack of funds; FDA approved a topical form of diclofenac during study, no need to continue study of pharmacy-compounded drug.
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 Breast PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Robin L. Smith, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276419
- Sponsor's protocol ID
- 92-05
- Status last verified
- Dec 2012
- First submitted
- 11 Jan 2006
- Last updated
- 20 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Diclofenac for the Treatment of Noncyclic Breast Pain
- ClinicalTrials.gov ID
- NCT00276419
- Acronym / sponsor ID
- 92-05
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funds; FDA approved a topical form of diclofenac during study, no need to continue study of pharmacy-compounded drug.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 13 Jan 2006 (estimated)
- Results
- Posted 13 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was a randomized, double-blinded, crossover trial of topical diclofenac and placebo (10 weeks of each) for the treatment of noncyclic breast pain.
Detailed description
A prospective, randomized, double-blinded crossover trial comparing topical diclofenac and placebo for 10 weeks in the treatment of 30 women with noncyclic mastalgia and surgical scar-related breast pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo First, then Diclofenac (Arm A) | Experimental | Drug: Diclofenac, Drug: PlaceboPlacebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks. |
| Diclofenac First, then Placebo (Arm B) | Experimental | Drug: Diclofenac, Drug: PlaceboCompounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Noncyclic mastalgia or surgical scar-related pain occurring at least 2 days per week and for which the patient desires treatment
- Duration of pain > 2 months (noncyclic mastalgia) or > 4 months (surgical scar-related pain)
- Age > 18 years
- Satisfactory breast examination and directed ultrasound at site of pain (all ages) within 12 months
- Satisfactory mammogram (all women > 30 years of age) within 12 months
Key exclusion criteria (9 listed)
- Cyclic mastalgia (as defined above)
- Duration of pain > 2 months (noncyclic mastalgia) or > 4 months (surgical scar-related pain)
- Abnormal breast examination or imaging (abnormality at the site of pain or for which biopsy or surgical consultation is recommended)
- Known pregnancy, lactation, positive pregnancy test, or anticipated pregnancy within 6 months
- Asthma, that has been aggravated by oral nonsteroidal antiinflammatory agents
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 |
|---|---|---|
| DiclofenacAlso: Cambia, Cataflam, Voltaren, VoltarolCompounded topical diclofenac cream applied to the skin three times daily for 10 weeks | Drug | Diclofenac First, then Placebo (Arm B), Placebo First, then Diclofenac (Arm A) |
| PlaceboPlacebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks | Drug | Diclofenac First, then Placebo (Arm B), Placebo First, then Diclofenac (Arm A) |
Primary outcome
Frequency of Breast Pain
Time frame: 4 weeks, 10 weeks
Participants will complete a breast pain diary indicating the sensation of pain on a daily basis. The frequency of breast pain will be determined by the number of days per week that the subject recorded experiencing pain at 4 weeks and 10 weeks of each treatment.
Severity of Breast Pain
Time frame: 4 weeks, 10 weeks
Severity will measured using a 100 mm visual analog scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain severity VAS, 0 means no pain and 100 means extreme pain. The investigator measures the written mark of the participant in mm, and records this for the value of pain severity. The severity of breast pain will be determined by the mean of breast pain scores (determined for all days and for days for which pain is greater than 0) at 4 weeks and 10 weeks of each treatment.
1 secondary outcome
Mean Days of Pain During the 10 Week Treatment Periods
Time frame: Approximately 12 weeks and at 24 weeks after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
- 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.
Robin L. Smith, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Diclofenac in people with Breast Pain and Non-cyclical Mastalgia, run by Mayo Clinic 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 6 inclusion and 9 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 20 Dec 2012. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2012). 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?
Frequency of Breast Pain (time frame: 4 weeks, 10 weeks). The study lists 2 primary outcomes in all. 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 20 Dec 2012.