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

NCT00276419 | Terminated Phase 2 Results

• 1 other identifier: 92-05
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Pain; Non-cyclical Mastalgia; Surgical Scar-Related Breast Pain

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Mean Days of Pain During the 10 Week Treatment Periods

  Approximately 12 weeks and at 24 weeks after randomization

Study Arms (2)

Placebo First, then Diclofenac (Arm A)

EXPERIMENTAL

Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.

Drug: Diclofenac; Drug: Placebo

Diclofenac First, then Placebo (Arm B)

EXPERIMENTAL

Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.

Drug: Diclofenac; Drug: Placebo

Interventions

Diclofenac DRUG

Compounded topical diclofenac cream applied to the skin three times daily for 10 weeks

Also known as: Cambia, Cataflam, Voltaren, Voltarol, Zipsor

Diclofenac First, then Placebo (Arm B); Placebo First, then Diclofenac (Arm A)

Placebo DRUG

Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks

Diclofenac First, then Placebo (Arm B); Placebo First, then Diclofenac (Arm A)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Mastodynia

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Limitations and Caveats

This study was terminated early due to lack of funds; the FDA approved a topical form of diclofenac during study, therefore there was no need to continue study of pharmacy-compounded drug.

Results Point of Contact

• Title: Dr. Robin L. Smith
• Organization: Mayo Clinic

smith.robin@mayo.edu

507-284-1210

Study Officials

• Robin L. Smith, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 11, 2006
• First Posted: January 13, 2006
• Study Start: June 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: December 20, 2012
• Results First Posted: December 13, 2012

Record last verified: 2012-12

Locations

US (1)