Video Capsule Endoscopy to Investigate the Safety and Tolerability of Lumiracoxib in the Small Bowel

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00350155
First received: July 5, 2006
Last updated: December 12, 2007
Last verified: December 2007
  Purpose

This study is designed to investigate the potential differences in GI safety and tolerability in the small bowel between lumiracoxib, conventional non-selective NSAID (naproxen) with a proton pump inhibitor (omeprazole), or placebo.


Condition Intervention Phase
Healthy Volunteers
Drug: Lumiracoxib
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 16-Day, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Trial Comparing Lumiracoxib 100mg o.d. With Naproxen 500 mg b.i.d. Plus Omeprazole 20mg o.d. and Placebo in Healthy Volunteers to Investigate on the Safety and Tolerability of Lumiracoxib in the Small Bowel.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of subjects with one or more small bowel mucosal breaks (with or without hemorrhage) detected by video capsule endoscopy

Secondary Outcome Measures:
  • Total number of small bowel mucosal breaks (with or without hemorrhage) detected by video capsule endoscopy
  • Percentage of subjects with one or more small bowel lesion detected by video capsule endoscopy
  • Total number of small bowel lesions detected by video capsule endoscopy
  • Value of small bowel inflammation (as measured by calprotectin test)
  • Value of lower GI permeability for lumiracoxib (as measured by differential urinary excretion of sugars)

Estimated Enrollment: 150
Study Start Date: May 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Healthy male or female subjects

Exclusion Criteria:

  • Evidence of cardiovascular, hepatic, gastrointestinal or renal disorders
  • Hereditary problems of galactose intolerance, a severe lactase deficiency or glucose-galactose malabsorption syndrome
  • Smokers

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00350155

Locations
Germany
Wiesbaden, Germany
United Kingdom
Nottingham, United Kingdom
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharma AG Novartis Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00350155     History of Changes
Other Study ID Numbers: CCOX189A2425
Study First Received: July 5, 2006
Last Updated: December 12, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Video capsule endoscopy, healthy volunteers, naproxen, omeprazole, lumiracoxib, small bowel

Additional relevant MeSH terms:
Omeprazole
Lumiracoxib
Diclofenac
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 15, 2014