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NCT05450627 Clinical Trial

Registry of Pancreatic Exocrine Insufficiency.

Exocrine Pancreatic Insufficiency Clinical Trial

Official title:
Development of a Registry of Patients With Pancreatic Exocrine Insufficiency of Different Etiologies

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05450627
Other study ID # PEI-01-2021
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date December 31, 2023

Study information
Verified date July 2022
Source Hospital Clinico Universitario de Santiago
Contact J. Enrique Dominguez-Munoz, Prof, MD, PhD
Phone -34 981 951 364
Email juan.enrique.dominguez.munoz@sergas.es
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

A prospective, cross-sectional, observational study has been designed with the aim of the study is to evaluate the diagnosis and management of patients with pancreatic exocrine insufficiency secondary to different pancreatic diseases and conditions in clinical practice. A registry has been develop to include patients older than 18 years diagnosed with pancreatic exocrine insufficiency, sho are willing to participate in the study and sign the informed consent. Registry includes demographics, toxic habits,pharmacological therapies, underlying disease that causes pancreatic exocrine insufficiency.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date December 31, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients older than 18 years diagnosed with PEI secondary to pancreatic diseases, pancreatectomy, or gastrectomy. - Willingness to participate in the study. Exclusion Criteria: - Patients with pancreatic diseases without PEI. - Pregnancy - Known allergy to oral pancreatic enzymes - Any condition avoiding adequate clinical management of PEI. - Patients who are not willing to participate in the study.

Study Design

Related Conditions & MeSH terms

  • Exocrine Pancreatic Insufficiency

Intervention

Drug:
• Pancreatic Enzyme
Registry of pancreatic enzyme therapy prescribed to included patients

Locations
Country Name City State
Spain Hospital Clinico Universitario de Santiago Santiago de Compostela A Coruña

Sponsors (1)
Lead Sponsor Collaborator
Hospital Clinico Universitario de Santiago

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dose of oral pancreatic enzymes Dose required for symptoms relief and normalization of the nutritional status Six months
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