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

NCT00630279 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2009-08-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Solvay Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Director Solvay · Solvay Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Czechia
  • Denmark
  • Hungary
  • Latvia
  • Poland
  • Russia
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00630279 on ClinicalTrials.gov