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Lack of funds; FDA approved a topical form of diclofenac during study, no need to continue study of pharmacy-compounded drug.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo First, then Diclofenac (Arm A) | Experimental | 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) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac | Drug | Compounded topical diclofenac cream applied to the skin three times daily for 10 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Breast Pain | 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. | 4 weeks, 10 weeks |
| Severity of Breast Pain | 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. | 4 weeks, 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Days of Pain During the 10 Week Treatment Periods | 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. | Approximately 12 weeks and at 24 weeks after randomization |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Robin L. Smith, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Wash-out Phase |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Diclofenac First, Then Placebo (Arm B) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Breast Pain | 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. | Posted | 4 weeks, 10 weeks |
|
Adverse events were collected over the 22 weeks of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection grade 2 | General disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robin L. Smith | Mayo Clinic | 507-284-1210 | smith.robin@mayo.edu |
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| ID | Term |
|---|---|
| D059373 | Mastodynia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks |
|
| NOT COMPLETED |
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| NOT COMPLETED |
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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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Severity of Breast Pain | 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. | Posted | 4 weeks, 10 weeks |
|
|
| Secondary | Mean Days of Pain During the 10 Week Treatment Periods | 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. | Posted | Approximately 12 weeks and at 24 weeks after randomization |
|
|
| 0 |
| 18 |
| 1 |
| 18 |
| EG001 | Diclofenac | Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks. | 0 | 18 | 1 | 18 |
| Dry skin of hand and scalp | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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