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Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome

Primary Purpose

Interstitial Cystitis, Bladder Pain Syndrome

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IW-3300 rectal foam
Placebo
Sponsored by
Ironwood Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosed with IC/BPS by a urologist or other clinician specializing in IC/BPS Chronic bladder pain associated with filling the bladder over the past 6 months Compliant with eDiary completion and meets weekly average daily score for bladder pain at its worst during the pretreatment period Has at least 1 of the following urinary symptoms over the past 6 months: nocturia ≥2 voids/night, daytime frequency >8×day, urgency Body mass index (BMI) ≤40 kg/m2 Willing to use a rectally administered product once daily for 12 weeks Exclusion Criteria: Male subject has history of bacterial prostatitis or benign prostatic hyperplasia Has a condition that can be a contraindication to using a rectal foam Has cancer under active treatment or a history of uterine, cervical, pelvic, rectal, ovarian, or vaginal cancer Has a history of benign or malignant bladder tumors Has an active urinary tract infection or had ≥2 UTIs within the past 90 days Has an uncontrolled major psychiatric condition or has made a suicide attempt during the past 2 years Has a malabsorption syndrome Had surgery in the pelvic or abdominal region within the past 90 days Has received a cystoscopy (with or without hydrodistension for reason other than pain relief) for diagnostic purposes within the past 30 days or a cystoscopy involving therapeutic hydrodistension (for pain relief) within the past 90 days Has history of pelvic irradiation or radiation cystitis Has a recent history of drug or alcohol abuse

Sites / Locations

  • Ironwood Research Center
  • Ironwood Research Center
  • Urological Associates of Southern ArizonaRecruiting
  • American Institute of ResearchRecruiting
  • Tri Valley Urology Medical GroupRecruiting
  • UCI HealthRecruiting
  • Ironwood Research Center
  • Ironwood Research Center
  • Ironwood Research Center
  • Valencia Medical and Research CenterRecruiting
  • Clinical Associates of OrlandoRecruiting
  • Altus ResearchRecruiting
  • Precision Clinical ResearchRecruiting
  • South Tampa Health ServicesRecruiting
  • Ironwood Research Center
  • Leavitt Clinical ResearchRecruiting
  • First Urology PSCRecruiting
  • Ochsner Clinic FoundationRecruiting
  • Bay State Clinical TrialsRecruiting
  • William Beaumont HospitalRecruiting
  • Michigan Institute of UrologyRecruiting
  • Quality Clinical ResearchRecruiting
  • Ironwood Research Center
  • New Mexico Clinical Research and Osteoporosis CenterRecruiting
  • Urological Institute of Northeast New YorkRecruiting
  • Accumed Research AssociatesRecruiting
  • Ironwood Research Site
  • Ironwood Research Center
  • Ironwood Research Center
  • Ironwood Research Center
  • Ironwood Research Center
  • Ironwood Research Center
  • Genesis Healthcare SystemRecruiting
  • Ironwood Research Center
  • Ironwood Research Center
  • Ironwood Research Center
  • Ironwood Research Center
  • Chattanooga Medical ResearchRecruiting
  • New Phase Research & DevelopmentRecruiting
  • Ironwood Research Center
  • Ironwood Research Center
  • Advances In Health IncRecruiting
  • Highland Clinical ResearchRecruiting
  • The Chronic Pelvic Pain CenterRecruiting
  • Seattle Clinical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

IW-3300 100 µg

IW-3300 300 µg

Placebo

Arm Description

IW-3300 at 100 µg rectal foam administered daily for 12 weeks

IW-3300 at 300 µg rectal foam administered daily for 12 weeks

Placebo rectal foam administered daily for 12 weeks

Outcomes

Primary Outcome Measures

Change from baseline (CFB) in weekly average of daily bladder pain (which can include sensations like burning, pressure, and/or discomfort) at its worst at Week 12
Subject assessment of bladder pain at its worst will be reported via a daily electronic Diary (eDiary)

Secondary Outcome Measures

CFB in weekly average of a burning sensation in the bladder at its worst at Week 12
Subject assessment of bladder burning sensation at its worst will be reported via an eDiary
CFB in weekly average of a pressure sensation in the bladder at its worst at Week 12
Subject assessment of bladder pressure sensation at its worst will be reported via an eDiary
CFB in weekly average of discomfort in the bladder at its worst at Week 12
Subject assessment of discomfort in the bladder at its worst will be reported via an eDiary
CFB in Genitourinary Pain Index (GUPI) Pain subscale score at Week 12
The GUPI assesses the degree of symptoms with genitourinary pain complaints over the last week, including experience of pain or discomfort in various areas, frequency of pain/discomfort, average pain/discomfort, frequency of urinary symptoms, and quality of life (QoL) impact
Frequency of Treatment-emergent adverse events (TEAEs) occurring in ≥2% of subjects
Frequency of TEAEs occurring in ≥2% of subjects
Overall frequency of TEAEs by severity grade
Overall frequency of TEAEs by severity grade

Full Information

First Posted
February 13, 2023
Last Updated
October 16, 2023
Sponsor
Ironwood Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05740007
Brief Title
Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome
Official Title
Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 2 Dose Levels of IW-3300 to Treat Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2023 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ironwood Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to assess whether IW-3300 is safe and works for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). The main question the study aims to answer is whether IW-3300 helps bladder pain and other symptoms (for example, bladder burning, pressure and discomfort). Subjects will be assigned to receive either the study drug or placebo by chance.
Detailed Description
This is a Phase 2, randomized, placebo-controlled, parallel-assignment, 12-week, adaptive design study to evaluate the efficacy, safety, and tolerability of IW-3300 in subjects with IC/BPS. Subjects will be randomized 1:1:1 to IW-3300 100 µg, IW-3300 300 µg, or matching placebo administered as a rectal foam. The study has 4 periods, which are the screening (up to 30 days), pretreatment (up to 21 days), study treatment (12 weeks), and follow-up periods (2 weeks) which consists of 7 onsite study visits and 1 follow-up phone call. Subjects will administer the study drug at home for 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis, Bladder Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IW-3300 100 µg
Arm Type
Experimental
Arm Description
IW-3300 at 100 µg rectal foam administered daily for 12 weeks
Arm Title
IW-3300 300 µg
Arm Type
Experimental
Arm Description
IW-3300 at 300 µg rectal foam administered daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo rectal foam administered daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
IW-3300 rectal foam
Intervention Description
IW-3300 rectal foam administered daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo rectal foam administered daily for 12 weeks
Primary Outcome Measure Information:
Title
Change from baseline (CFB) in weekly average of daily bladder pain (which can include sensations like burning, pressure, and/or discomfort) at its worst at Week 12
Description
Subject assessment of bladder pain at its worst will be reported via a daily electronic Diary (eDiary)
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
CFB in weekly average of a burning sensation in the bladder at its worst at Week 12
Description
Subject assessment of bladder burning sensation at its worst will be reported via an eDiary
Time Frame
Baseline, Week 12
Title
CFB in weekly average of a pressure sensation in the bladder at its worst at Week 12
Description
Subject assessment of bladder pressure sensation at its worst will be reported via an eDiary
Time Frame
Baseline, Week 12
Title
CFB in weekly average of discomfort in the bladder at its worst at Week 12
Description
Subject assessment of discomfort in the bladder at its worst will be reported via an eDiary
Time Frame
Baseline, Week 12
Title
CFB in Genitourinary Pain Index (GUPI) Pain subscale score at Week 12
Description
The GUPI assesses the degree of symptoms with genitourinary pain complaints over the last week, including experience of pain or discomfort in various areas, frequency of pain/discomfort, average pain/discomfort, frequency of urinary symptoms, and quality of life (QoL) impact
Time Frame
Baseline, Week 12
Title
Frequency of Treatment-emergent adverse events (TEAEs) occurring in ≥2% of subjects
Description
Frequency of TEAEs occurring in ≥2% of subjects
Time Frame
Baseline, Week 12
Title
Overall frequency of TEAEs by severity grade
Description
Overall frequency of TEAEs by severity grade
Time Frame
Baseline, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with IC/BPS by a urologist or other clinician specializing in IC/BPS Chronic bladder pain associated with filling the bladder over the past 6 months Compliant with eDiary completion and meets weekly average daily score for bladder pain at its worst during the pretreatment period Has at least 1 of the following urinary symptoms over the past 6 months: nocturia ≥2 voids/night, daytime frequency >8×day, urgency Body mass index (BMI) ≤40 kg/m2 Willing to use a rectally administered product once daily for 12 weeks Exclusion Criteria: Male subject has history of bacterial prostatitis or benign prostatic hyperplasia Has a condition that can be a contraindication to using a rectal foam Has cancer under active treatment or a history of uterine, cervical, pelvic, rectal, ovarian, or vaginal cancer Has a history of benign or malignant bladder tumors Has an active urinary tract infection or had ≥2 UTIs within the past 90 days Has an uncontrolled major psychiatric condition or has made a suicide attempt during the past 2 years Has a malabsorption syndrome Had surgery in the pelvic or abdominal region within the past 90 days Has received a cystoscopy (with or without hydrodistension for reason other than pain relief) for diagnostic purposes within the past 30 days or a cystoscopy involving therapeutic hydrodistension (for pain relief) within the past 90 days Has history of pelvic irradiation or radiation cystitis Has a recent history of drug or alcohol abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Manager
Phone
617-621-7722
Email
info@ironwoodpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Ironwood Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Ironwood Research Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ironwood Research Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Urological Associates of Southern Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J Simpson
Email
jsimpson@arizonauro.com
Facility Name
American Institute of Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
N Aguillon
Email
naguillon@airesearch.us
Facility Name
Tri Valley Urology Medical Group
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A Deeds
Email
anita@trivalleyurology.com
Facility Name
UCI Health
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
P Linh Huynh
Email
plhuynh@hs.uci.edu
Facility Name
Ironwood Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ironwood Research Center
City
Vacaville
State/Province
California
ZIP/Postal Code
95688
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ironwood Research Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Valencia Medical and Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Y Chaviano
Email
ychaviano@valenciamedresearch.com
Facility Name
Clinical Associates of Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C Martin
Email
cmartin@clinicalassociatesorlando.com
Facility Name
Altus Research
City
Palm Springs
State/Province
Florida
ZIP/Postal Code
33406
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S Feliz
Email
sfeliz@altusresearch.com
Facility Name
Precision Clinical Research
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Y Tapia
Email
yobankat@pcrflorida.com
Facility Name
South Tampa Health Services
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M Lewis
Email
study-team@gcpclinicalresearch.com
Facility Name
Ironwood Research Center
City
Cartersville
State/Province
Georgia
ZIP/Postal Code
30120
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Leavitt Clinical Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
L Carranza
Email
liz@drleavitt.net
Facility Name
First Urology PSC
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C Hensley
Email
chensley@1sturology.com
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R Graham
Email
rgraham@ochsner.org
Facility Name
Bay State Clinical Trials
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
T Lafleur
Email
tmlbsct@gmail.com
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
E Zagaja
Email
erica.zagaja@beaumont.org
Facility Name
Michigan Institute of Urology
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
D Osterhout
Email
osterhoutd@michiganurology.com
Facility Name
Quality Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J Larsen
Email
jenny@qcromaha.com
Facility Name
Ironwood Research Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
New Mexico Clinical Research and Osteoporosis Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
T Salazar
Email
TSalazar@nmbonecare.com
Facility Name
Urological Institute of Northeast New York
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
L Davey
Email
amcurologyresearch@mail.amc.edu
Facility Name
Accumed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H Delmauro
Email
heather.accumedresearch@gmail.com
Facility Name
Ironwood Research Site
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ironwood Research Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ironwood Research Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ironwood Research Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ironwood Research Center
City
Gahanna
State/Province
Ohio
ZIP/Postal Code
43230
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ironwood Research Center
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Genesis Healthcare System
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C Griffin
Email
Cgriffin2@genesishcs.org
Facility Name
Ironwood Research Center
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ironwood Research Center
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ironwood Research Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ironwood Research Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Chattanooga Medical Research
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R Raybon
Email
jricks@chattmedresearch.com
Facility Name
New Phase Research & Development
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H Triebel
Email
htriebel@newphaseonline.com
Facility Name
Ironwood Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ironwood Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77096
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Advances In Health Inc
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
E Loya
Email
elizabethloya@aihresearch.com
Facility Name
Highland Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S Mueller
Email
saramueller2@outlook.com
Facility Name
The Chronic Pelvic Pain Center
City
Vienna
State/Province
Virginia
ZIP/Postal Code
22182
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C Prieston
Email
case.cppc@gmail.com
Facility Name
Seattle Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S Emerald
Email
semerald@seattlecrc.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome

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