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

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. Identifier: NCT01990898
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : April 19, 2017
Last Update Posted : April 19, 2017
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Treatment Cyclosporine

Participant Flow:   Overall Study
3 Months   22 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Treatment Cyclosporine

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      20  76.9% 
>=65 years      6  23.1% 
[Units: Years]
Mean (Full Range)
 (27 to 74) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      14  53.8% 
Male      12  46.2% 
Region of Enrollment 
[Units: Participants]
United States   26 

  Outcome Measures

1.  Primary:   Symptom Improvement of Interstitial Cystitis   [ Time Frame: 3 Months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

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 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