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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00350155
First Posted: July 10, 2006
Last Update Posted: December 13, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00350155


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

ClinicalTrials.gov Identifier: NCT00350155     History of Changes
Other Study ID Numbers: CCOX189A2425
First Submitted: July 5, 2006
First Posted: July 10, 2006
Last Update Posted: December 13, 2007
Last Verified: December 2007

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

Additional relevant MeSH terms:
Omeprazole
Naproxen
Lumiracoxib
Diclofenac
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Cyclooxygenase 2 Inhibitors