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

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Pain; Non-cyclical Mastalgia; Surgical Scar-Related Breast Pain

Intervention: Diclofenac (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Terminated

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Robin L. Smith, M.D., Principal Investigator, Affiliation: Mayo Clinic

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.

Clinical Details

Official title: Topical Diclofenac for the Treatment of Noncyclic Breast Pain

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Frequency of Breast Pain

Severity of Breast Pain

Secondary outcome: Mean Days of Pain During the 10 Week Treatment Periods

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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)

Locations and Contacts

Mayo Clinic, Rochester, Minnesota 55905, United States
Additional Information

Mayo Clinic Clinical Trials

Starting date: June 2005
Last updated: December 13, 2012

Page last updated: August 23, 2015

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