Status:
TERMINATED
Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin
Lead Sponsor:
Mayo Clinic
Conditions:
Breast Pain
Non-cyclical Mastalgia
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
Brief 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.
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 p...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00276419
Start Date
June 1 2005
End Date
May 1 2009
Last Update
December 20 2012
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905