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Intravesical Liposomes for Ulcerative Cystitis

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: NCT01083979
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : February 8, 2017
Last Update Posted : February 8, 2017
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Interstitial Cystitis
Intervention: Drug: Liposomes

  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
Liposomes Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.

Participant Flow:   Overall Study

  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
Liposomes Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      1 100.0% 
>=65 years      0   0.0% 
[Units: Participants]
Count of Participants
Female      1 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
United States   1 

  Outcome Measures

1.  Primary:   Change in Symptom and Problem Severity   [ Time Frame: Baseline to 12 weeks ]

2.  Secondary:   Bladder Appearance   [ Time Frame: Baseline to 12 Weeks ]

  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
This was a single-subject treatment study. Therefore the data analysis and results are limited and are not generalizable.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Kenneth M. Peters, MD
Organization: William Beaumont Hospital
phone: 248-551-0387
e-mail: kmpeters@beaumont.edu

Responsible Party: Kenneth Peters, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01083979     History of Changes
Other Study ID Numbers: 2010-021
First Submitted: March 8, 2010
First Posted: March 10, 2010
Results First Submitted: December 24, 2013
Results First Posted: February 8, 2017
Last Update Posted: February 8, 2017