Trial Outcomes & Findings for A Pilot Study of the Effects of Mirabegron on Symptoms in Patients With Interstitial Cystitis (NCT NCT02787083)

NCT ID: NCT02787083

Last Updated: 2019-12-03

Results Overview

Evaluate urinary urgency, frequency and pain via validated O'Leary Sant questionnaire

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 9 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2019-12-03

Participant Flow

Participant milestones

Measure	Mirabegron These patients will receive mirabegron 50mg tablets daily for 12 weeks. Mirabegron	Placebo These patients will receive placebo tablets daily for 12 weeks. Placebo
Overall Study STARTED	4	5
Overall Study COMPLETED	1	3
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	Mirabegron These patients will receive mirabegron 50mg tablets daily for 12 weeks. Mirabegron	Placebo These patients will receive placebo tablets daily for 12 weeks. Placebo
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	2	2

Baseline Characteristics

A Pilot Study of the Effects of Mirabegron on Symptoms in Patients With Interstitial Cystitis

Baseline characteristics by cohort

Measure	Mirabegron n=4 Participants These patients will receive mirabegron 50mg tablets daily for 12 weeks. Mirabegron	Placebo n=5 Participants These patients will receive placebo tablets daily for 12 weeks. Placebo	Total n=9 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	4 Participants n=5 Participants	5 Participants n=7 Participants	9 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	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
Systolic	145 MMHg n=5 Participants	145 MMHg n=7 Participants	145 MMHg n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Evaluate urinary urgency, frequency and pain via validated O'Leary Sant questionnaire

Outcome measures

Measure	Mirabegron n=1 Participants These patients will receive mirabegron 50mg tablets daily for 12 weeks. Mirabegron	Placebo n=3 Participants These patients will receive placebo tablets daily for 12 weeks. Placebo
Number of Participants With Interstitial Cystitis Symptom Improvement	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 12 weeks

Evaluate incontinence episodes via bladder diary and UDI-6 questionnaire

Outcome measures

Measure	Mirabegron n=1 Participants These patients will receive mirabegron 50mg tablets daily for 12 weeks. Mirabegron	Placebo n=3 Participants These patients will receive placebo tablets daily for 12 weeks. Placebo
Number of Participants With Improvement in Incontinence Episodes	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 12 weeks

Evaluate impact on quality of life from bladder, bowel and vaginal/pelvic symptoms via PFIQ-7 questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

evaluate participant satisfaction with treatment/placebo via Global response assessment form

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Evaluate changes in sexual function via FSFI questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Will assess if participants have side effects of medication via office visits

Outcome measures

Outcome data not reported

Adverse Events

Mirabegron

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mirabegron n=4 participants at risk These patients will receive mirabegron 50mg tablets daily for 12 weeks. Mirabegron	Placebo n=5 participants at risk These patients will receive placebo tablets daily for 12 weeks. Placebo
Cardiac disorders Headache	25.0% 1/4 • Number of events 1 • The adverse event happened in the beginning of the study within a 3 month period. The participants were all healthy adults	0.00% 0/5 • The adverse event happened in the beginning of the study within a 3 month period. The participants were all healthy adults

Additional Information

Kristene E Whitmore MD

Philadelphia Urosurgical Associates, PC

Phone: 215-704-1457

Email: bladder1@aol.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60