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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 : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Seikagaku Corporation

Tracking Information
First Submitted Date  ICMJE November 25, 2019
First Posted Date  ICMJE December 23, 2019
Last Update Posted Date September 11, 2020
Actual Study Start Date  ICMJE March 30, 2020
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2019)
  • Maximum observed plasma concentration (Cmax) [ Time Frame: 4 weeks ]
    To assess Cmax after single dose of SI-722
  • Time to reach the Maximum observed plasma concentration (Tmax) [ Time Frame: 4 weeks ]
    To assess tmax after dose of SI-722
  • Cumulative amount of drug excreted in urine (Ae) [ Time Frame: 4 weeks ]
    To assess Ae after dose of SI-722
  • 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
  • Cystoscopy [ Time Frame: 4 weeks ]
    To assess abnormal change from baseline in cystoscopy
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2019)
  • Subject Diary [ Time Frame: 4 weeks ]
    To assess change from baseline in bladder pain, symptoms, voiding frequency and voiding volume
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PK and Safety of SI-722 in IC/BPS
Official Title  ICMJE 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
Brief Summary This study is designed randomized, double-blind, placebo-controlled trial in Interstitial Cystitis/Bladder Pain Syndrome patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Interstitial Cystitis
  • Bladder Pain Syndrome
Intervention  ICMJE
  • Drug: SI-722
    SI-722 will be intravesically instilled.
  • Drug: Placebo
    Placebo will be intravesically instilled.
Study Arms  ICMJE
  • Experimental: SI-722
    Intervention: Drug: SI-722
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 18, 2019)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hiroyuki Hosokawa +81-3-5220-8593 722_clinical_project_team@seikagaku.co.jp
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04208087
Other Study ID Numbers  ICMJE 722/1121
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seikagaku Corporation
Study Sponsor  ICMJE Seikagaku Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seikagaku Corporation
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP