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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:

ClinicalTrials.gov Identifier:

NCT00276419

First Posted: January 13, 2006

Last Update Posted: December 20, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Mayo Clinic

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 Intervention Model: Crossover Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Topical Diclofenac for the Treatment of Noncyclic Breast Pain

Resource links provided by NLM:

MedlinePlus related topics: Breast Diseases

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Frequency of Breast Pain [ Time Frame: 4 weeks, 10 weeks ]
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 ]
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 ]
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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site


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
First Submitted:	January 11, 2006
First Posted:	January 13, 2006
Results First Submitted:	November 16, 2012
Results First Posted:	December 13, 2012
Last Update Posted:	December 20, 2012
Last Verified:	December 2012

Additional relevant MeSH terms:


Mastodynia Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Diclofenac Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics	Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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