NCT00350155

Brief Summary

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_4 healthy-volunteers

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
Last Updated

December 13, 2007

Status Verified

December 1, 2007

First QC Date

July 5, 2006

Last Update Submit

December 12, 2007

Conditions

Healthy Volunteers

Keywords

Video capsule endoscopy, healthy volunteers, naproxen, omeprazole, lumiracoxib, small bowel

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

  • 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)

Interventions

LumiracoxibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male or female subjects

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Wiesbaden, Germany

Location

Unknown Facility

Nottingham, United Kingdom

Location

MeSH Terms

Interventions

lumiracoxib

Study Officials

  • Novartis Pharma AG

    Novartis Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 5, 2006

First Posted

July 10, 2006

Study Start

May 1, 2006

Last Updated

December 13, 2007

Record last verified: 2007-12

Locations

DE(1)GB(1)