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Trial record 58 of 158 for:    interstitial cystitis

Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)

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: NCT01731470
Recruitment Status : Completed
First Posted : November 21, 2012
Results First Posted : January 10, 2017
Last Update Posted : January 10, 2017
Sponsor:
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Interstitial Cystitis
Pelvic Pain
Intervention Biological: Liposomes
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Liposomes
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Liposomes

Liposomes: Intravesical instillation of liposomes.

Period Title: Overall Study
Started 16 [1]
Completed 14 [2]
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Did not meet study criteria             1
[1]
Number of patients consented to participate in the study
[2]
Number of patients enrolled in the study
Arm/Group Title Liposomes
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Liposomes

Liposomes: Intravesical instillation of liposomes.

Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
  75.0%
>=65 years
4
  25.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
13
  81.3%
Male
3
  18.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   6.3%
White
15
  93.8%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Change in Symptom Severity at 4 and 8 Weeks Post-Treatment as Measured by the Total O'Leary-Sant IC Symptom and Problem Index (ICSI/ICPI) Score
Hide Description The O’Leary-Sant IC Symptom Index (ICS-I) total score ranges from 0 to 20 and the Problem Index (ICP-I) total score ranges from 0 to 16. Each index has 4 questions and lower scores represent a better outcome. A total ICSI/ICPI score is obtained by adding the total scores from both indices. The combined ICSI/ICPI total score ranges from 0 to 36.
Time Frame 4 and 8 weeks post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liposomes
Hide Arm/Group Description:

Liposomes

Liposomes: Intravesical instillation of liposomes.

Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Baseline to 4 Weeks Post Treatment
-4
(-7 to -1)
Baseline to 8 Weeks Post Treatment
-4
(-8 to -1)
2.Secondary Outcome
Title Change in Pain Scores at 4 and 8 Weeks Post-Treatment as Measured by the Visual Analog Scale (VAS)
Hide Description Patients utilized the Visual Analog Scale (VAS) to describe their pain. The scale ranges from 0:No pain to 10: Pain as bad as it could possibly be.
Time Frame 4 and 8 weeks post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liposomes
Hide Arm/Group Description:

Liposomes

Liposomes: Intravesical instillation of liposomes.

Overall Number of Participants Analyzed 14
Mean (Inter-Quartile Range)
Unit of Measure: units on a scale
Baseline to 4 Weeks Post
-2
(-3.82 to 0.00)
Baseline to 8 Weeks Post-Treatment
-1.14
(-3.90 to -0.90)
Time Frame Adverse event data were collected for approximately 12 weeks, from the first treatment visit through 8 weeks post-treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Liposomes
Hide Arm/Group Description

Liposomes

Liposomes: Intravesical instillation of liposomes.

All-Cause Mortality
Liposomes
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Liposomes
Affected / at Risk (%) # Events
Total   0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Liposomes
Affected / at Risk (%) # Events
Total   4/14 (28.57%)    
Gastrointestinal disorders   
Irritable Bowel *  1/14 (7.14%)  1
Nausea *  1/14 (7.14%)  1
Musculoskeletal and connective tissue disorders   
Muscle Pull *  1/14 (7.14%)  1
Pinched Nerve *  1/14 (7.14%)  1
Fracture *  1/14 (7.14%)  1
Renal and urinary disorders   
Hematuria *  1/14 (7.14%)  1
Infection *  1/14 (7.14%)  2
Respiratory, thoracic and mediastinal disorders   
Pneumonia *  1/14 (7.14%)  1
*
Indicates events were collected by non-systematic assessment
This was an open-label trial without evaluation of placebo effects.
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: Kenneth Peters MD
Organization: Beaumont Hospital, Royal Oak
Phone: 248-551-0387
Responsible Party: Kenneth Peters, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01731470     History of Changes
Other Study ID Numbers: 2012-024
First Submitted: November 15, 2012
First Posted: November 21, 2012
Results First Submitted: May 12, 2016
Results First Posted: January 10, 2017
Last Update Posted: January 10, 2017