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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 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.

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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.

Interventions

  • DRUG Placebo
  • DRUG Clarix Flo

Study Locations (1)

Ohio

  • University Hospitals - Clevleand

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2024-07-24
Est. Completion 2026-06
Phase Phase 2

Sponsor

David Sheyn

3 total trials

What the Registry Record Tells You About NCT06096597

The ClinicalTrials.gov registry entry for NCT06096597 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 358-participant average among 26 other Interstitial Cystitis trials with a reported enrollment target (72% lower). The listed sponsor is David Sheyn, which has 3 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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