MedDataX Logo

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

NCT ID: NCT00276419

Last Updated: 2012-12-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2009-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Diclofenac

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo for Diclofenac in topical 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.

Group Type EXPERIMENTAL

Diclofenac

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diclofenac

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cambia Cataflam Voltaren Voltarol Zipsor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Division of General Internal Medicine, Mayo Clinic, Rochester Minnesota

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robin L. Smith, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

92-05

Identifier Type: -

Identifier Source: org_study_id