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ongoing trials trial from www.clinicaltrials.gov

OPTION 2: A Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Cystic Fibrosis - Phase 2 - Not yet recruiting

  • Year: 2020
  • Date: July 1, 2020
  • Author: AzurRx BioPharma, Inc.
Source

https://ClinicalTrials.gov/show/NCT04375878

Study design (if review, criteria of inclusion for studies)

Interventional - Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Treatment

Participants

Exocrine Pancreatic Insufficiency (EPI)|Cystic Fibrosis (CF) - 18 Years and older   (Adult, Older Adult)

Interventions

Drug: MS1819|Drug: Porcine PERT

Outcome measures

Safety of MS1819 by number of subjects reporting 1 or more adverse events|Efficacy of MS1819: Coefficient of fat absorption (CFA)|Stool weights|Signs and symptoms of malabsorption|Coefficient of Nitrogen Absorption (CNA)

Keywords: Gastrointestinal Diseases; pharmacological_intervention; Pancreas insufficiency; Pancreatic Diseases; Pancreatic Enzyme Replacement Therapy; Malabsorption; Nutrition Disorders; Gastrointestinal Agents;