NCT00630279

Dose-ranging Study to Evaluate Efficacy of SLV339 in Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

A Multi-center, Single-blind, Parallel-design, Randomized, Placebo-controlled, Dose-ranging Study to Evaluate Oral Recombinant Microbial Lipase Efficacy in Patients With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Solvay Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to estimate the efficacy of a number of doses in patients with pancreatic insufficiency

Conditions

• Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

Interventions

Type	Name	Description
DRUG	Placebo	Placebo
DRUG	Recombinant Microbial Lipase SLV339	oral, 150 mg/d, 7 days treatment
DRUG	Recombinant Microbial Lipase SLV339	oral, 300 mg/d, 7 days treatment
DRUG	Recombinant Microbial Lipase SLV339	oral, 600 mg/d, 7 days treatment

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-03-06
• Last updated: 2009-08-06

Locations

50 sites across 7 countries: Czechia, Denmark, Hungary, Latvia, Poland, Russia, Sweden