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

This study has been terminated.
(Lack of funds; FDA approved a topical form of diclofenac during study, no need to continue study of pharmacy-compounded drug.)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00276419
First received: January 11, 2006
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Breast Pain
Non-cyclical Mastalgia
Surgical Scar-Related Breast Pain
Drug: Diclofenac
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topical Diclofenac for the Treatment of Noncyclic Breast Pain

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Frequency of Breast Pain [ Time Frame: 4 weeks, 10 weeks ] [ Designated as safety issue: No ]
    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.

  • Severity of Breast Pain [ Time Frame: 4 weeks, 10 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mean Days of Pain During the 10 Week Treatment Periods [ Time Frame: Approximately 12 weeks and at 24 weeks after randomization ] [ Designated as safety issue: No ]
    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.


Enrollment: 25
Study Start Date: June 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo First, then Diclofenac (Arm A)
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
Compounded topical diclofenac cream applied to the skin three times daily for 10 weeks
Other Names:
  • Cambia
  • Cataflam
  • Voltaren
  • Voltarol
  • Zipsor
Drug: Placebo
Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks
Experimental: Diclofenac First, then Placebo (Arm B)
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
Compounded topical diclofenac cream applied to the skin three times daily for 10 weeks
Other Names:
  • Cambia
  • Cataflam
  • Voltaren
  • Voltarol
  • Zipsor
Drug: Placebo
Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276419

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Robin L. Smith, M.D. Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Robin L. Smith, MD; principal investigator, Division of General Internal Medicine, Mayo Clinic, Rochester Minnesota
ClinicalTrials.gov Identifier: NCT00276419     History of Changes
Other Study ID Numbers: 92-05
Study First Received: January 11, 2006
Results First Received: November 16, 2012
Last Updated: December 13, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Mastodynia
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Diclofenac
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014