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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
Results First Received: November 16, 2012  
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
Conditions: Breast Pain
Non-cyclical Mastalgia
Surgical Scar-Related Breast Pain
Interventions: Drug: Diclofenac
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
25 Participants were recruited at the Mayo Clinic in Rochester Minnesota from June 2005 to May 2009. Seven subjects withdrew after randomization, prior to treatment, 6 in arm A, and 1 in arm B.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
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.

Participant Flow for 3 periods

 Period 1:   First Intervention
    Placebo First, Then Diclofenac (Arm A)     Diclofenac First, Then Placebo (Arm B)  
STARTED     8     10  
COMPLETED     7     8  
NOT COMPLETED     1     2  
Adverse Event                 1                 0  
Withdrawal by Subject                 0                 2  

Period 2:   Wash-out Phase
    Placebo First, Then Diclofenac (Arm A)     Diclofenac First, Then Placebo (Arm B)  
STARTED     7     8  
COMPLETED     7     8  
NOT COMPLETED     0     0  

Period 3:   Second Intervention
    Placebo First, Then Diclofenac (Arm A)     Diclofenac First, Then Placebo (Arm B)  
STARTED     7     8  
COMPLETED     7     8  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    Placebo First, Then Diclofenac (Arm A)     Diclofenac First, Then Placebo (Arm B)     Total  
Number of Participants  
[units: participants]
 		  8     10     18  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     8     10     18  
>=65 years     0     0     0  
Gender  
[units: participants]
 		     
Female     8     10     18  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     8     10     18  



  Outcome Measures
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1.  Primary:   Frequency of Breast Pain   [ Time Frame: 4 weeks, 10 weeks ]
  Show Outcome Measure 1

2.  Primary:   Severity of Breast Pain   [ Time Frame: 4 weeks, 10 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Mean Days of Pain During the 10 Week Treatment Periods   [ Time Frame: Approximately 12 weeks and at 24 weeks after randomization ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:  
Name/Title: Dr. Robin L. Smith
Organization: Mayo Clinic
phone: 507-284-1210
e-mail: smith.robin@mayo.edu


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