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

• Status: Terminated
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Diclofenac

Criteria

Inclusion criteria

• 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)

Exclusion criteria

• 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)