Video Capsule Endoscopy to Investigate the Safety and Tol... | NCT00350155

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

NCT00350155

Sponsor

Novartis

Status

Completed

Last Update Posted

Dec 13, 2007Estimated

Enrollment

150

Phase

Phase 4

Conditions

Healthy Volunteers

Interventions

Lumiracoxib

Countries

Germany
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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.

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 5, 2006

First Submission Date that Met QC Criteria

Jul 5, 2006

First Posted Date

Jul 10, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2007

Last Update Posted Date

Dec 13, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150

Name	Type	Description	Arm Group Labels	Other Names
Lumiracoxib	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis Pharma AG	Novartis Pharmaceuticals	Study Chair

Intervention Browse Module

MeSH Terms

ID	Term
C473384	lumiracoxib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Wiesbaden			Germany