Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis



Status:Archived
Conditions:Other Indications, Urology
Therapuetic Areas:Nephrology / Urology, Other
Healthy:No
Age Range:Any
Updated:7/1/2011

Use our guide to learn which trials are right for you!

Randomized, Double-Blind, Placebo-Controlled, Parallel Group Evaluation of the Efficacy and Tolerability of Two Different Doses of ELMIRON for the Treatment of Interstitial Cystitis


The purpose of this study is to evaluate the safety and effectiveness of pentosan
polysulfate sodium 100 mg once a day, pentosan polysulfate sodium 100 mg three times a day,
and placebo for 24 weeks for the relief of bladder pain or discomfort associated with
interstitial cystitis.


The purpose of this multi-center, double-blind (neither the patient nor the physician knows
whether drug or placebo is being taken, or at what dosage), randomized (patients are
assigned different treatments based on chance), parallel group trial is to evaluate the
effectiveness and safety of two doses of pentosan polysulfate sodium (100 mg once a day and
100 mg three times a day) versus placebo for 24 weeks for the relief of bladder pain or
discomfort associated with interstitial cystitis. The hypothesis of the study is that there
is no treatment difference in the proportion of responders at study endpoint (Week 24).
Effectiveness will be assessed based on the reduction in the O'Leary-Sant Interstitial
Cystitis Symptom Index (ICSI) total score. Safety assessments include vital signs,
laboratory tests, adverse events and physical exams. Patients will receive one of the
following study treatments by mouth each day for 24 weeks: pentosan polysulfate sodium 100
mg once a day group - one pentosan polysulfate sodium 100 mg capsule in the morning, and one
matching placebo capsule in the afternoon and evening; pentosan polysulfate sodium 100 mg
capsule three times a day group - one pentosan polysulfate sodium 100 mg capsule in the
morning, afternoon and evening; placebo group - one placebo capsule in the morning,
afternoon and evening


We found this trial at
25
sites
Philadelphia, Pennsylvania
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Albany, New York
?
mi
from
Albany, NY
Click here to add this to my saved trials
Anchorage, Alaska
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
Atlanta, Georgia
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas
?
mi
from
Austin, TX
Click here to add this to my saved trials
Birmingham, Alabama
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Celebration, Florida
?
mi
from
Celebration, FL
Click here to add this to my saved trials
Centralia, Illinois
?
mi
from
Centralia, IL
Click here to add this to my saved trials
Charlotte, North Carolina
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Denver, Colorado
?
mi
from
Denver, CO
Click here to add this to my saved trials
Detroit, Michigan
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Henderson, Nevada
?
mi
from
Henderson, NV
Click here to add this to my saved trials
Jeffersonville, Indiana
?
mi
from
Jeffersonville, IN
Click here to add this to my saved trials
?
mi
from
Lima, OH
Click here to add this to my saved trials
Medford, Oregon
?
mi
from
Medford, OR
Click here to add this to my saved trials
Milwaukee, Wisconsin
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Mountlake Terrace, Washington
?
mi
from
Mountlake Terrace, WA
Click here to add this to my saved trials
Nashville, Tennessee
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Newington, Connecticut
?
mi
from
Newington, CT
Click here to add this to my saved trials
?
mi
from
Ogden, UT
Click here to add this to my saved trials
Ponca City, Oklahoma
?
mi
from
Ponca City, OK
Click here to add this to my saved trials
Richmond, Virginia
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Santa Clara, California 95051
?
mi
from
Santa Clara, CA
Click here to add this to my saved trials
St Louis, Missouri
?
mi
from
St Louis, MO
Click here to add this to my saved trials
West Orange, New Jersey
?
mi
from
West Orange, NJ
Click here to add this to my saved trials