Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Breast Pain, Non-cyclical Mastalgia, Surgical Scar-Related Breast Pain

In brief

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.

Key facts

Study ID

NCT00276419

Run by

Mayo Clinic

People needed

25

Starts

2005-06-01

Expected to finish

2009-05-01

Last updated by the study team

2012-12-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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
• 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)

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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