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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
History of Changes

January 11, 2006
December 13, 2012
June 2005
May 2009   (final data collection date for primary outcome measure)
  • 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.
  • Frequency of breast pain
  • Severity of breast pain
Complete list of historical versions of study NCT00276419 on ClinicalTrials.gov Archive Site
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.
  • Side effects
  • Adherence
  • Level of anxiety generated by breast symptoms
Not Provided
Not Provided
 
Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin
Topical Diclofenac for the Treatment of Noncyclic Breast Pain

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.

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Breast Pain
  • Non-cyclical Mastalgia
  • Surgical Scar-Related Breast Pain
  • 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: 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.
    Interventions:
    • Drug: Diclofenac
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Diclofenac
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
May 2009
May 2009   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00276419
92-05
No
Robin L. Smith, MD; principal investigator, Division of General Internal Medicine, Mayo Clinic, Rochester Minnesota
Mayo Clinic
Not Provided
Principal Investigator: Robin L. Smith, M.D. Mayo Clinic
Mayo Clinic
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP