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Clinical Trials/EUCTR2011-006019-73-GB
EUCTR2011-006019-73-GB
Active, not recruiting
Phase 1

Randomized, double blind, placebo-controlled trial of Creon in patients with low faecal pancreatic elastase - Creon use in patients with low faecal pancreatic elastase

Sheffield Teaching Hospitals NHS Foundation Trust0 sites2 target enrollmentSeptember 24, 2012

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Pancreatic Insufficiency
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Enrollment
2
Status
Active, not recruiting
Last Updated
7 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 24, 2012
End Date
May 22, 2015
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patients with chronic diarrhoea (\>3 loose/ liquid motions a day for more than 4 weeks)
  • Patients with a low faecal elastase (\<200 µg/g),
  • Patients aged 16 years or over
  • Patients able to give written consent to participate
  • Patients not currently on Creon
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range 35
  • F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • Patients with normal faecal elastase (\> 201µg/g),
  • Patients under the age of 16
  • Patients allergic to pork or any pig product (advice from the drug manufacturer)
  • Patients that are pregnant or are breast\-feeding
  • Patients taking alternative medication that could affect bowel frequency
  • Where an alternative diagnosis for the chronic diarrhoea is established, these patients will be excluded from the trial

Outcomes

Primary Outcomes

Not specified

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