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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787083
Recruitment Status : Terminated (Low enrollment)
First Posted : June 1, 2016
Results First Posted : December 3, 2019
Last Update Posted : December 3, 2019
Sponsor:
Collaborator:
Astellas Pharma Global Development, Inc.
Information provided by (Responsible Party):
Kristene Whitmore, Philadelphia Urosurgical Associates

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Cystitis, Interstitial
Interventions Drug: Mirabegron
Drug: Placebo
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mirabegron Placebo
Hide Arm/Group Description

These patients will receive mirabegron 50mg tablets daily for 12 weeks.

Mirabegron

These patients will receive placebo tablets daily for 12 weeks.

Placebo

Period Title: Overall Study
Started 4 5
Completed 1 3
Not Completed 3 2
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             2             2
Arm/Group Title Mirabegron Placebo Total
Hide Arm/Group Description

These patients will receive mirabegron 50mg tablets daily for 12 weeks.

Mirabegron

These patients will receive placebo tablets daily for 12 weeks.

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 4 5 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
5
 100.0%
9
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
Female
4
 100.0%
5
 100.0%
9
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
 100.0%
5
 100.0%
9
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 5 participants 9 participants
4 5 9
Systolic  
Mean (Full Range)
Unit of measure:  MMHg
Number Analyzed 4 participants 5 participants 9 participants
145
(110 to 180)
145
(110 to 180)
145
(110 to 180)
1.Primary Outcome
Title Number of Participants With Interstitial Cystitis Symptom Improvement
Hide Description Evaluate urinary urgency, frequency and pain via validated O'Leary Sant questionnaire
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mirabegron Placebo
Hide Arm/Group Description:

These patients will receive mirabegron 50mg tablets daily for 12 weeks.

Mirabegron

These patients will receive placebo tablets daily for 12 weeks.

Placebo

Overall Number of Participants Analyzed 1 3
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
3
 100.0%
2.Secondary Outcome
Title Number of Participants With Improvement in Incontinence Episodes
Hide Description Evaluate incontinence episodes via bladder diary and UDI-6 questionnaire
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mirabegron Placebo
Hide Arm/Group Description:

These patients will receive mirabegron 50mg tablets daily for 12 weeks.

Mirabegron

These patients will receive placebo tablets daily for 12 weeks.

Placebo

Overall Number of Participants Analyzed 1 3
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
3
 100.0%
3.Secondary Outcome
Title Impact on Quality of Life
Hide Description Evaluate impact on quality of life from bladder, bowel and vaginal/pelvic symptoms via PFIQ-7 questionnaire
Time Frame 12 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Patient Satisfaction
Hide Description evaluate participant satisfaction with treatment/placebo via Global response assessment form
Time Frame 12 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Sexual Function
Hide Description Evaluate changes in sexual function via FSFI questionnaire
Time Frame 12 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Side Effects of Medication
Hide Description Will assess if participants have side effects of medication via office visits
Time Frame 12 weeks
Outcome Measure Data Not Reported
Time Frame The adverse event happened in the beginning of the study within a 3 month period.
Adverse Event Reporting Description The participants were all healthy adults
 
Arm/Group Title Mirabegron Placebo
Hide Arm/Group Description

These patients will receive mirabegron 50mg tablets daily for 12 weeks.

Mirabegron

These patients will receive placebo tablets daily for 12 weeks.

Placebo

All-Cause Mortality
Mirabegron Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/5 (0.00%)    
Hide Serious Adverse Events
Mirabegron Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/5 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mirabegron Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      0/5 (0.00%)    
Cardiac disorders     
Headache   1/4 (25.00%)  1 0/5 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kristene E Whitmore MD
Organization: Philadelphia Urosurgical Associates, PC
Phone: 215-704-1457
EMail: bladder1@aol.com
Layout table for additonal information
Responsible Party: Kristene Whitmore, Philadelphia Urosurgical Associates
ClinicalTrials.gov Identifier: NCT02787083    
Other Study ID Numbers: MYRB-15G02
First Submitted: May 23, 2016
First Posted: June 1, 2016
Results First Submitted: October 3, 2019
Results First Posted: December 3, 2019
Last Update Posted: December 3, 2019