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NCT06096597 · ClinicalTrials.gov registry record · Phase 2
Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
A Phase 2 study of Interstitial Cystitis and Painful Bladder Syndrome, sponsored by David Sheyn.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06096597: Recruiting Phase 2 study of Interstitial Cystitis and Painful Bladder Syndrome, sponsored by David Sheyn.
NCT06096597 is a Phase 2 study of Interstitial Cystitis and Painful Bladder Syndrome that is actively recruiting participants, run by David Sheyn. The registered enrollment target is 100 participants, below the 358-participant average among 26 other Interstitial Cystitis trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06096597, a Phase 2 study of Interstitial Cystitis and Painful Bladder Syndrome, is actively recruiting participants, sponsored by David Sheyn.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Interstitial cystitis/painful bladder syndrome (IC/PBS) is a clinical syndrome in which patients report symptoms of bladder and/or pelvic pain with pressure and/ or discomfort associated with urinary frequency and urgency. The primary objective of this study is to determine the efficacy of amniotic membrane therapy in patients with interstitial cystitis/painful bladder syndrome (IC/PBS) as defined by clinically-significant improvement in validated symptom questionnaires.
Primary Outcome
Evaluate for clinically-meaningful reduction in symptoms as defined as a 5 point reduction in Interstitial Cystitis Symptom Index (ICSI)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Clarix Flo
Study Locations (1)
Ohio
- University Hospitals - Clevleand
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-07-24 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
What NCT06096597 shows while recruiting
NCT06096597 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 358-participant average among 26 other Interstitial Cystitis trials with a reported enrollment target (72% lower).
The record links to 3 conditions, with Interstitial Cystitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06096597 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06096597 about?
NCT06096597 is a clinical study titled "Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome". Interstitial cystitis/painful bladder syndrome (IC/PBS) is a clinical syndrome in which patients report symptoms of bladder and/or pelvic pain with pressure and/ or discomfort associated with urinary frequency and urgency. The primary objective of this study is to determine the efficacy of amniotic...
What is the current status of trial NCT06096597?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2024-07-24. Estimated completion is 2026-06.
What conditions does trial NCT06096597 study?
This clinical trial studies the following conditions: Interstitial Cystitis, Painful Bladder Syndrome, Painful Bladder Syndrome (PBS).
What interventions are being tested in trial NCT06096597?
The interventions under investigation include: Placebo (DRUG), Clarix Flo (DRUG).
Who is sponsoring clinical trial NCT06096597?
This trial is sponsored by David Sheyn, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06096597 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Interstitial Cystitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06096597's enrollment target sits among peer trials
100 11th of 26 higher than 15 of 26 other Interstitial Cystitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Interstitial Cystitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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