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PK and Safety of SI-722 in IC/BPS

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208087
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
Seikagaku Corporation

Brief Summary:
This study is designed randomized, double-blind, placebo-controlled trial in Interstitial Cystitis/Bladder Pain Syndrome patients.

Condition or disease Intervention/treatment Phase
Interstitial Cystitis Bladder Pain Syndrome Drug: SI-722 Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of SI-722 Intravesical Instillation in Interstitial Cystitis/Bladder Pain Syndrome Subjects
Actual Study Start Date : March 30, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SI-722 Drug: SI-722
SI-722 will be intravesically instilled.

Placebo Comparator: Placebo Drug: Placebo
Placebo will be intravesically instilled.




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: 4 weeks ]
    To assess Cmax after single dose of SI-722

  2. Time to reach the Maximum observed plasma concentration (Tmax) [ Time Frame: 4 weeks ]
    To assess tmax after dose of SI-722

  3. Cumulative amount of drug excreted in urine (Ae) [ Time Frame: 4 weeks ]
    To assess Ae after dose of SI-722

  4. Number of participants with treatment-related adverse events [ Time Frame: 4 weeks ]
    To assess the incidence of treatment-related adverse events after dose of SI-722

  5. Cystoscopy [ Time Frame: 4 weeks ]
    To assess abnormal change from baseline in cystoscopy

  6. Number of participants with clinical significant change in vital signs, electrocardiograms and clinical laboratory assessments [ Time Frame: 4 weeks ]
    Number of participants with clinical significant change in vital signs, electrocardiograms and clinical laboratory assessments will be assessed.


Secondary Outcome Measures :
  1. Subject Diary [ Time Frame: 4 weeks ]
    To assess change from baseline in bladder pain, symptoms, voiding frequency and voiding volume

  2. Interstitial Cystitis Symptom Index Score/Problem Index Score [ Time Frame: 4 weeks ]

    Interstitial Cystitis Symptom Index Score/Problem Index Score (ICSI/PI) will be used to assess the change from baseline of the symptoms of IC/BPS. ICSI and ICPI have 4-items respectively.

    Regarding ICSI, each item on the questionnaire is scored from 0 to 5 and this means that a person can score between 0 and 20 for symptom of IC/BPS.

    Regarding ICPI, each item on the questionnaire is scored from 0 to 4 and this means that a person can score between 0 and 16 for problem of IC/BPS.

    These higher scores mean a worse outcome.


  3. Bladder Pain/Interstitial Cystitis Symptom Score [ Time Frame: 4 weeks ]

    Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS) will be used to assess change from baseline of the symptoms of IC/BPS.

    Questions 1-7 are scored from 0-4, and question 8 is scored from 0-10. Using these 8 questions, person can score between 0 and 38. These higher scores mean a worse outcome.


  4. Global Response Assessment [ Time Frame: 4 weeks ]

    Global Response Assessment (GRA) will be used to assess change from baseline of the symptoms of IC/BPS.

    This questionnaire includes 7 point scale which is centered at zero (no change): markedly worse; moderately worse; slightly worse; no change; slightly improved; moderately improved; and markedly improved.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females, ≥18 and ≤80 years of age
  • A score of 19 or greater on the Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS)

Exclusion Criteria:

  • Urinary tract infection ≤30 days
  • Treatment with intravesical therapy ≤60 days
  • Treatment with any opioid therapy ≤7 days
  • History of bladder hydrodistension ≤3 months
  • Has cancer or a past history of any cancer ≤5 years
  • Body mass index (BMI) ≥40 kg/m2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208087


Contacts
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Contact: Hiroyuki Hosokawa +81-3-5220-8593 722_clinical_project_team@seikagaku.co.jp

Locations
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United States, California
American Institute of Research Recruiting
Los Angeles, California, United States, 90017
TriValley Urology Medical Group Recruiting
Murrieta, California, United States, 92562
United States, Florida
Premier Medical Associates Recruiting
The Villages, Florida, United States, 32159
United States, New York
AccuMed Research Associates Recruiting
Garden City, New York, United States, 11530
United States, Texas
Centex Studies Recruiting
Houston, Texas, United States, 77058
Sponsors and Collaborators
Seikagaku Corporation
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Responsible Party: Seikagaku Corporation
ClinicalTrials.gov Identifier: NCT04208087    
Other Study ID Numbers: 722/1121
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seikagaku Corporation:
Bladder
Intravesical Injection
Interstitial Cystitis
Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Syndrome
Disease
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases