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Trial record 4 of 158 for:    interstitial cystitis

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

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ClinicalTrials.gov Identifier: NCT01990898
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : April 19, 2017
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Interstitial Cystitis
Intervention Drug: Cyclosporine
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment
Hide Arm/Group Description Cyclosporine
Period Title: Overall Study
Started 26
3 Months 22
Completed 22
Not Completed 4
Arm/Group Title Treatment
Hide Arm/Group Description Cyclosporine
Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
  76.9%
>=65 years
6
  23.1%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 26 participants
50
(27 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
14
  53.8%
Male
12
  46.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants
26
1.Primary Outcome
Title Symptom Improvement of Interstitial Cystitis
Hide Description 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.
Time Frame 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:
Cyclosporine
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: Participants
9
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment
Hide Arm/Group Description Cyclosporine
All-Cause Mortality
Treatment
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment
Affected / at Risk (%)
Total   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment
Affected / at Risk (%)
Total   2/26 (7.69%) 
Cardiac disorders   
Hypertension  1/26 (3.85%) 
Endocrine disorders   
Elevated Serum Glucose  1/26 (3.85%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Name/Title: Dr. Daniel Shoskes
Organization: Cleveland Clinic
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01990898     History of Changes
Other Study ID Numbers: 13-1271
First Submitted: November 18, 2013
First Posted: November 25, 2013
Results First Submitted: October 26, 2016
Results First Posted: April 19, 2017
Last Update Posted: April 19, 2017