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

Breast Pain Clinical Trial

Official title:

Topical Diclofenac for the Treatment of Noncyclic Breast Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00276419
• Other study ID #: 92-05
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: January 11, 2006
• Last updated: December 13, 2012
• Start date: June 2005
• Est. completion date: May 2009

Study information

• Verified date: December 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Breast Pain
• Mastodynia
• Non-cyclical Mastalgia
• Surgical Scar-Related Breast Pain

Intervention

Drug:
• Diclofenac
Compounded topical diclofenac cream applied to the skin three times daily for 10 weeks
• Placebo
Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks, 10 weeks	No
Primary	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.	4 weeks, 10 weeks	No
Secondary	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.	Approximately 12 weeks and at 24 weeks after randomization	No

External Links

•   Mayo Clinic Clinical Trials