Healthy VolunteersPhase 4NCT00350155
Video Capsule Endoscopy to Investigate the Safety and Tolerability of Lumiracoxib in the Small Bowel
A Phase 4 study testing Lumiracoxib in people with Healthy Volunteers, run by Novartis at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Lumiracoxib
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2006to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Healthy male or female subjects
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
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.
- Conditions
- Healthy Volunteers
- Being tested
- Lumiracoxib
- Keywords
- Video capsule endoscopy, healthy volunteers, naproxen, omeprazole, lumiracoxib, small bowel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumiracoxibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharma AG, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350155
- Sponsor's protocol ID
- CCOX189A2425
- Status last verified
- Dec 2007
- First submitted
- 5 Jul 2006
- Last updated
- 13 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00350155
- Acronym / sponsor ID
- CCOX189A2425
- Conditions
- Healthy Volunteers
- Keywords
- Video capsule endoscopy, healthy volunteers, naproxen, omeprazole, lumiracoxib, small bowel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- May 2006
- First posted
- 10 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy male or female subjects
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumiracoxib | Drug | – |
Primary outcome
Percentage of subjects with one or more small bowel mucosal breaks (with or without hemorrhage) detected by video capsule endoscopy
5 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2007.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharma AG study chair
Novartis Pharmaceuticals
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lumiracoxib in people with Healthy Volunteers, run by Novartis at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with one or more small bowel mucosal breaks (with or without hemorrhage) detected by video capsule endoscopy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2007.