Dose finding study of JTE-051

Phase II study of JTE-051 -Dose finding study in patients with interstitial cystitis-

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210042

Enrollment

150

Registered

2021-04-20

Start date

2021-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Cystitis/Bladder Pain Syndrome

Interventions

JTE-051 or placebo will be administered orally once daily

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosed with interstitial cystitis or bladder pain syndrome 2. Japanese patient aged >=20 and <75 at the time of informed consent 3. Satisfied with protocol-defined criteria for NRS average bladder pain score, ICSI score, and daily urinary frequency

Exclusion criteria

Exclusion criteria: 1. Have been received therapies (e.g., transurethral resection/fulguration, intravesical instillation, or hydrodistension) during protocol-specified period 2. Have history of augmentation cystoplasty, cystectomy or urinary diversion 3. Found to meet protocol-defined conditions determined by screening results (e.g., laboratory tests) 4. Presence of severe hepatic diseases 5. Presence or history within 5 years of malignancy

Design outcomes

Primary

Measure	Time frame
Change from baseline in NRS average bladder pain score	—

Contacts

Public Contactinformation clinical trials

Shionogi & Co.,Ltd.

clinicaltrials-info@shionogi.co.jp+81-3-6635-3505

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026