CFDB - Cystic Fibrosis DataBase

ongoing trials trial from www.clinicaltrials.gov

OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis - Phase 2 - Not yet recruiting

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-SD|Drug: Porcine PERT

Outcome measures

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

Keywords: Oral; Pancreatic Enzyme Replacement Therapy; MS1819; Supplementation; Pancreas insufficiency; Pancreatic Diseases; Gastrointestinal Diseases; Malabsorption; Nutrition Disorders; Capsules; pharmacological_intervention; Gastrointestinal Agents;