Trial Outcomes & Findings for Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin (NCT NCT00276419)

Last Updated: 2012-12-20

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

25 participants

Primary outcome timeframe

4 weeks, 10 weeks

Results posted on

2012-12-20

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
First Intervention STARTED	8	10
First Intervention COMPLETED	7	8
First Intervention NOT COMPLETED	1	2
Wash-out Phase STARTED	7	8
Wash-out Phase COMPLETED	7	8
Wash-out Phase NOT COMPLETED	0	0
Second Intervention STARTED	7	8
Second Intervention COMPLETED	7	8
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
First Intervention Adverse Event	1	0
First Intervention Withdrawal by Subject	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo First, Then Diclofenac (Arm A) n=8 Participants 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) n=10 Participants 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 n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	10 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks, 10 weeks

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Diclofenac

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=18 participants at risk Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks	Diclofenac n=18 participants at risk Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
General disorders Infection grade 2	5.6% 1/18 • Number of events 1 • Adverse events were collected over the 22 weeks of the study.	0.00% 0/18 • Adverse events were collected over the 22 weeks of the study.
Skin and subcutaneous tissue disorders Dry skin of hand and scalp	0.00% 0/18 • Adverse events were collected over the 22 weeks of the study.	5.6% 1/18 • Number of events 1 • Adverse events were collected over the 22 weeks of the study.

Additional Information

Dr. Robin L. Smith

Mayo Clinic

Phone: 507-284-1210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place