Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01259544 | BreathID® Test: A Non-invasive Modality to Detect Pancreatic Exocrine Insufficiency | PHASE2 | COMPLETED | 33 | — | — | Jan 1, 2009 | Mar 1, 2009 | Dec 20, 2022 | 1 | India |
This breath test substrate is new and is hypothesized, based on preliminary studies, that it may be the answer to a much needed non-invasive pancreatic function test. At first stage, it will be compared to the current invasive gold standard: secretin induced ePFT.
| Arm | Type | Description |
|---|---|---|
| Di -petide breath tests and ePFT secretin induced | ACTIVE_COMPARATOR | Di peptide breath tests will be performed on subjects with known chronic pancreatitis |
| c13 di peptide breath tests | ACTIVE_COMPARATOR | Healthy volunteers to compare breath tests results to subjects with chronic pancreatitis |
| Name | Type | Description |
|---|---|---|
| benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala) | DRUG | 300 mg of powder form dissolved in one cup of tap water prior to breath test |
Inclusion Criteria: 1. Patients with chronic pancreatitis who meet at least one of the following criteria: * Adult men or women \>18 years of age. * Endoscopic retrograde cholangiopancreatography (ERCP), magnetic resonance cholangiopancreatography (MRCP), or endoscopic ultrasound demonstrati...