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Intravesical Liposomes for Ulcerative Cystitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01083979
First received: March 8, 2010
Last updated: December 14, 2016
Last verified: December 2016
Results First Received: December 24, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Interstitial Cystitis
Intervention: Drug: Liposomes

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

Participant Flow:   Overall Study
    Liposomes
STARTED   1 
COMPLETED   1 
NOT COMPLETED   0 



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

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


  Outcome Measures
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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
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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
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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
Study First Received: March 8, 2010
Results First Received: December 24, 2013
Last Updated: December 14, 2016