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Trial Outcomes & Findings for Cyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of Action (NCT NCT01990898)

NCT ID: NCT01990898

Last Updated: 2017-04-19

Results Overview

Number of participants with \> 30% Improved Interstitial Cystitis Symptoms Index (ICSI) which is measured on a scale from 0 - 19 where the higher numbers are worse. No additional analyses have been done.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

3 Months

Results posted on

2017-04-19

Participant Flow

Participant milestones

Participant milestones
Measure
Treatment
Cyclosporine
Overall Study
STARTED
26
Overall Study
3 Months
22
Overall Study
COMPLETED
22
Overall Study
NOT COMPLETED
4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of Action

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treatment
n=26 Participants
Cyclosporine
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
20 Participants
n=5 Participants
Age, Categorical
>=65 years
6 Participants
n=5 Participants
Age, Continuous
50 years
n=5 Participants
Sex: Female, Male
Female
14 Participants
n=5 Participants
Sex: Female, Male
Male
12 Participants
n=5 Participants
Region of Enrollment
United States
26 participants
n=5 Participants

PRIMARY outcome

Timeframe: 3 Months

Number of participants with \> 30% Improved Interstitial Cystitis Symptoms Index (ICSI) which is measured on a scale from 0 - 19 where the higher numbers are worse. No additional analyses have been done.

Outcome measures

Outcome measures
Measure
Treatment
n=22 Participants
Cyclosporine
Symptom Improvement of Interstitial Cystitis
9 Participants

Adverse Events

Treatment

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Treatment
n=26 participants at risk
Cyclosporine
Cardiac disorders
Hypertension
3.8%
1/26
Endocrine disorders
Elevated Serum Glucose
3.8%
1/26

Additional Information

Dr. Daniel Shoskes

Cleveland Clinic

Results disclosure agreements

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