HealthyLesions3NCT01090596
Changes in mRNA Expression Following Exposure to Naproxen
A study testing Naproxen in people with Healthy, run by Research Associates of New York, LLP.
Trial summary
Using tissue samples obtained from a previous study, the effect of naproxen on the gene expression profiles of antral mucosal tissue will be assessed. We hypothesize that there will be distinct changes in the gene expression profiles of samples taken from individuals treated with naproxen versus samples taken from… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Naproxen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Jul 2008
- Phase
- Interventional
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult between the ages of 18 and 75 inclusive
- Written informed consent prior to undergoing any study procedures
- A physical examination which reveals no clinically significant abnormalities
- Female subjects of childbearing potential must be taking an acceptable form of contraceptive
Who cannot join
- Any mucosal breaks within 2 cm of pyloric channel seen on baseline endoscopy
- Any GDU or >5 gastroduodenal erosions at baseline endoscopy
- CXB, CPG, ASA, or NS-NSAID use within the prior 2 weeks
- Previous gastrointestinal ulcer
- Hypersensitivity or allergy to NSAIDs, ASA, CPG, CXB or other contraindication to taking treatments
- Baseline complaints of abdominal pain, nausea, and/or cramping
Show all 12Show fewer
- Any acid blocking medication including antacids, H-2 receptor blocker within the prior 2 weeks, or PPI use within the prior 30 days
- Corticosteroids use within the prior 60 days
- Any documented bleeding tendency
- Has taken warfarin within the prior 60 days
- Three or greater alcoholic beverages daily
- History of cerebro-vascular event
About this study
Using tissue samples obtained from a previous study, the effect of naproxen on the gene expression profiles of antral mucosal tissue will be assessed. We hypothesize that there will be distinct changes in the gene expression profiles of samples taken from individuals treated with naproxen versus samples taken from individuals treated with placebo.
Read the detailed description
We will use microarray technology to quantify the transcriptome-wide changes in gene expression in said-samples.
- Conditions
- Healthy
- Being tested
- Naproxen, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaproxenDrug
500mg naproxen, twice daily for 7 days
PlaceboDrug
1 tab,twice a day for a seven days
| Study group | Role | What they receive |
|---|---|---|
| Naproxen-Treated | Active comparator | Not described Receives: Drug: Naproxen |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fold Change in Gene Expression
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2010 (estimated)
- Study startApr 2007
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Associates of New York, LLP
- Sponsor type
- University, hospital or other
- Investigators
- James Aisenberg, MD, Principal investigator, Research Associates of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090596
- Sponsor's protocol ID
- ResearchANY
- Acronym
- Lesions3
- Status last verified
- Mar 2010
- First submitted
- 17 Mar 2010
- Last updated
- 22 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in mRNA Expression Following Exposure to Naproxen
- ClinicalTrials.gov ID
- NCT01090596
- Acronym / sponsor ID
- Lesions3 / ResearchANY
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Research Associates of New York, LLPUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 22 Mar 2010 (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.
Using tissue samples obtained from a previous study, the effect of naproxen on the gene expression profiles of antral mucosal tissue will be assessed. We hypothesize that there will be distinct changes in the gene expression profiles of samples taken from individuals treated with naproxen versus samples taken from individuals treated with placebo.
Detailed description
We will use microarray technology to quantify the transcriptome-wide changes in gene expression in said-samples.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naproxen-Treated | Active comparator | Drug: Naproxen |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adult between the ages of 18 and 75 inclusive
- Written informed consent prior to undergoing any study procedures
- A physical examination which reveals no clinically significant abnormalities
- Female subjects of childbearing potential must be taking an acceptable form of contraceptive
Key exclusion criteria (12 listed)
- Any mucosal breaks within 2 cm of pyloric channel seen on baseline endoscopy
- Any GDU or >5 gastroduodenal erosions at baseline endoscopy
- CXB, CPG, ASA, or NS-NSAID use within the prior 2 weeks
- Previous gastrointestinal ulcer
- Hypersensitivity or allergy to NSAIDs, ASA, CPG, CXB or other contraindication to taking treatments
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 |
|---|---|---|
| Naproxen500mg naproxen, twice daily for 7 days | Drug | Naproxen-Treated |
| Placebo1 tab,twice a day for a seven days | Drug | placebo |
Primary outcome
Fold Change in Gene Expression
Time frame: 7 days
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 22 Mar 2010.
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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.
James Aisenberg, MD principal investigator
Research Associates of New York
Questions about this trial
What is this clinical trial studying?
A study testing Naproxen in people with Healthy, run by Research Associates of New York, LLP.
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 4 inclusion and 12 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 22 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Fold Change in Gene Expression (time frame: 7 days). 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 22 Mar 2010.