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NCT04548778
BÜHLMANN FPELA in the Diagnosis of Exocrine Pancreatic Insufficiency
trial testing BÜHLMANN fPELA assay in Exocrine Pancreatic Insufficiency in 201 participants. Completed in 21 September 2024.
21 September 2024
Quick facts
| Lead sponsor | Bühlmann Laboratories AG |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 201 |
| Start date | 1 November 2020 |
| Primary completion | 21 September 2024 |
| Estimated completion | 21 September 2024 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- BÜHLMANN fPELA assay
Conditions studied
- Exocrine Pancreatic Insufficiency — all drugs for Exocrine Pancreatic Insufficiency →
Sponsor
Bühlmann Laboratories AG
Who can join
18 and older, any sex, with Exocrine Pancreatic Insufficiency. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study shall determine the clinical performance of the BÜHLMANN fecal pancreatic elastase (fPELA) assays in the diagnosis of exocrine pancreatic insufficiency (PEI). This is a observational and cross-sectional performance study. Specimens and clinical data are collected by a single study site. Included are subjects for which pancreatic elastase testing was indicated due to a suspected exocrine pancreatic insufficiency and which were at least 18 years of age. Subjects which suffered from diarrhea (stool water content ≥ 75%) at the time of sample collection are excluded from the study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04548778
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for Exocrine Pancreatic Insufficiency
Currently open trials in the same condition.
- NCT05710315 — Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure · NA · recruiting
- NCT06477159 — Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency · Phase 4 · recruiting
- NCT05112328 — The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding · NA · recruiting
Other Bühlmann Laboratories AG trials
Trials by the same sponsor.
- NCT03408249 — IBDoc® Canadian User Performance Evaluation · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04548778 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bühlmann Laboratories AG
- Last refreshed: 16 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04548778.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing