Interstitial CystitisPhase 1/2NCT04208087

PK and Safety of SI-722 in IC/BPS

A Phase 1/2 study testing SI-722 in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Seikagaku Corporation at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study is designed randomized, double-blind, placebo-controlled trial in Interstitial Cystitis/Bladder Pain Syndrome patients. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Interstitial Cystitis, Bladder Pain Syndrome
What is being tested?: SI-722
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 33 participants
Where: 5 sitesUnited States
Study dates: 30 Mar 2020to 12 Jan 2021
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

AccuMed Research Associates
Garden City, New York, 11530
Centex Studies
Houston, Texas, 77058
American Institute of Research
Los Angeles, California, 90017
TriValley Urology Medical Group
Murrieta, California, 92562
Premier Medical Associates
The Villages, Florida, 32159

Other trials in United States

About this study

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

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

Conditions: Interstitial Cystitis, Bladder Pain Syndrome
Being tested: SI-722, Placebo
Keywords: Bladder, Intravesical Injection, Interstitial Cystitis
Medical subject headings: Cystitis, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SI-722Drug
SI-722 will be intravesically instilled.
PlaceboDrug
Placebo will be intravesically instilled.

Study groups in NCT04208087
Study group	Role	What they receive
SI-722	Experimental	Not described Receives: Drug: SI-722
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Plasma Concentration (Cmax) for SI-722
SI-722 concentrations in plasma were measured using collected blood samples, and plasma PK parameters for SI-722 were estimated.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Mar 202012 Jan 2021

First posted23 Dec 2019
Study start30 Mar 2020
Primary completion12 Jan 2021
Study completion12 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Interstitial CystitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04208087
Sponsor's protocol ID: 722/1121
Status last verified: Dec 2023
First submitted: 25 Nov 2019
Last updated: 29 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome

All Interstitial Cystitis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04208087
Acronym / sponsor ID: 722/1121
Conditions: Interstitial Cystitis, Bladder Pain Syndrome
Keywords: Bladder, Intravesical Injection, Interstitial Cystitis
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Seikagaku CorporationIndustry (pharma, biotech, devices)
Study start: 30 Mar 2020 (actual)
Primary completion: 12 Jan 2021 (actual)
Study completion: 12 Jan 2021 (actual)
First posted: 23 Dec 2019 (actual)
Results: Posted 29 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
SI-722	Experimental	Drug: SI-722
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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)

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SI-722SI-722 will be intravesically instilled.	Drug	SI-722
PlaceboPlacebo will be intravesically instilled.	Drug	Placebo

Primary outcome

Maximum Plasma Concentration (Cmax) for SI-722
Time frame: 4 weeks
SI-722 concentrations in plasma were measured using collected blood samples, and plasma PK parameters for SI-722 were estimated.

Results and safety

Results posted to the registry on 29 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	8	7
Low Dose of SI-722	6	6
Medium Dose of SI-722	6	5
Medium-high Dose of SI-722	6	6
High Dose of SI-722	7	6

Primary outcome: Maximum Plasma Concentration (Cmax) for SI-722

Time frame: 4 weeks. Mean (Standard Deviation). Unit: ng/mL

Measure	Low Dose of SI-722 n = 6	Medium Dose of SI-722 n = 6	Medium-high Dose of SI-722 n = 6	High Dose of SI-722 n = 6
Value	NA (NA)	NA (NA)	NA (NA)	NA (NA)

Population analysed: The PK Population is defined as all subjects who received SI-722 and who provided at least 1 evaluable PK sample. One participant in the High Dose group was excluded from PK population because the subject discontinued before IP administration due to difficulty with drawing blood.

Adverse events

Time frame: 4 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 8 (0%)	4 of 8 (50%)	0 of 8
Low Dose of SI-722	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Medium Dose of SI-722	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Medium-high Dose of SI-722	0 of 6 (0%)	3 of 6 (50%)	0 of 6
High Dose of SI-722	0 of 6 (0%)	3 of 6 (50%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Interstitial Cystitis

Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SI-722 in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Seikagaku Corporation at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Plasma Concentration (Cmax) for SI-722 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04208087.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.