Gastroduodenal UlcerPhase 4Lesions2NCT00778193
Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on the Healing of Stomach and Intestinal Ulcers
A Phase 4 study testing Naproxen, Aspirin and Celecoxib in people with Gastroduodenal Ulcer, run by Research Associates of New York, LLP at 1 site in United States.
Trial summary
Gastroduodenal ulcers are extremely common in the community today. Though much has been written and observed concerning how ulcers form, not much has been described in the human model concerning how these ulcers heal. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroduodenal Ulcer
- What is being tested?
- Naproxen, Aspirin and Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Mar 2008
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Age 18-75
- Use of appropriate form of birth control for women of childbearing potential.
Who cannot join
- H pylori infection
- Use of NSAIDs within 2 weeks prior to start of enrollment
- Use of antacids or H-2 blockers within 2 weeks of enrollment
- Use of PPIs within 30 days of enrollment
- Corticosteroid use within 60 days of enrollment
- History of a previous ulcer
Show all 14Show fewer
- Diagnosis of a bleeding diathesis or use of warfarin within 60 days of enrollment
- Use of cigarettes within 6 months of enrollment
- Consumption of >3 alcoholic beverages per day
- Hypersensitivity or allergy to NSAIDs, clopidogrel, or corn starch, or any contraindications to ingesting those substances
- The presence of an ulcer at a baseline endoscopy
- Endoscopically severe gastritis or duodenitis baseline endoscopy
- Moderate or severe inflammation located within the duodenal bulb or within 2cm of the pyloric channel at a baseline endoscopy
- Any gastroduodenal tumor.
Trial locations and contacts
1 site in 1 country.
United States1 site
Research Associates of New York
New York, New York, 10075
About this study
Official title: A Randomized, Blinded, Placebo-Controlled Study of the Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on Gastroduodenal Healing
Gastroduodenal ulcers are extremely common in the community today. Though much has been written and observed concerning how ulcers form, not much has been described in the human model concerning how these ulcers heal. As numerous patients already suffer from gastrointestinal ulcers, further clarification of ulcer healing would be valuable in the treatment and management of these patients. The goal of this study is to investigate the effects of naproxen, aspirin, celecoxib, and clopidogrel on biopsy-induced gastroduodenal lesions in order to elucidate the mechanisms of ulcer healing. This single site, single-blind, randomized, placebo-controlled, one-week prospective study will examine ulcer healing through endoscopic, immunohistologic, and molecular PCR modalities.
Read the detailed description
In order to assess the extent of healing of the biopsy sites, a 12-point scale was developed and validated.
After all of the procedures were complete, this scale was used to measure the effects of the study drugs on the healing of the biopsy-induced ulcers.
- Conditions
- Gastroduodenal Ulcer
- Being tested
- Naproxen, Aspirin, Celecoxib, Clopidogrel, Placebo
- Keywords
- NSAID, ulcer, gastroduodenal ulcer, naproxen, aspirin, ASA, celecoxib, clopidogrel, healing, Cyclooxygenase 2 Inhibitors, Anti-Inflammatory Agents, Non-Steroidal, Platelet Aggregation Inhibitors, Wound Healing
- Medical subject headings
- Peptic Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaproxenDrug
Also called naprosyn, naproxen sodium, Aleve, Anaprox
1 tablet 500mg BID for 8 days
AspirinDrug
Also called ASA, Bayer
1 tablet 81mg QD for 8 days
CelecoxibDrug
Also called Celebrex
1 capsule 200mg QD for 8 days
ClopidogrelDrug
Also called Plavix
Day 0: 4 tablets QD for 1 day; Days 1-7: 1 tablet QD for 7 days
PlaceboDrug
Also called sugar pill
1 capsule BID for 8 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Naproxen | Active comparator | Not described Receives: Drug: Naproxen |
| Aspirin | Experimental | Not described Receives: Drug: Aspirin |
| Clopidogrel | Experimental | Not described Receives: Drug: Clopidogrel |
| Celecoxib | Experimental | Not described Receives: Drug: Celecoxib |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startOct 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroduodenal UlcerStudies 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
- Enrolment
- 125 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
- NCT00778193
- Sponsor's protocol ID
- Healing Study
- Other IDs
- GA319181
- Acronym
- Lesions2
- Status last verified
- Oct 2008
- First submitted
- 24 Jul 2008
- Last updated
- 23 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Desai JC, Sanyal SM, Goo T, Benson AA, Bodian CA, Miller KM, Cohen LB, Aisenberg J. Primary prevention of adverse gastroduodenal effects from short-term use of non-steroidal anti-inflammatory drugs by omeprazole 20 mg in healthy subjects: a randomized, double-blind, placebo-controlled study. Dig Dis Sci. 2008 Aug;53(8):2059-65. doi: 10.1007/s10620-007-0127-4. Epub 2008 Jan 26.
PubMed 18224442
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Placebo-Controlled Study of the Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on Gastroduodenal Healing
- ClinicalTrials.gov ID
- NCT00778193
- Acronym / sponsor ID
- Lesions2 / Healing Study
- Conditions
- Gastroduodenal Ulcer
- Keywords
- NSAID, ulcer, gastroduodenal ulcer, naproxen, aspirin, ASA, celecoxib, clopidogrel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Research Associates of New York, LLPUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 23 Oct 2008 (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.
Gastroduodenal ulcers are extremely common in the community today. Though much has been written and observed concerning how ulcers form, not much has been described in the human model concerning how these ulcers heal. As numerous patients already suffer from gastrointestinal ulcers, further clarification of ulcer healing would be valuable in the treatment and management of these patients. The goal of this study is to investigate the effects of naproxen, aspirin, celecoxib, and clopidogrel on biopsy-induced gastroduodenal lesions in order to elucidate the mechanisms of ulcer healing. This single site, single-blind, randomized, placebo-controlled, one-week prospective study will examine ulcer healing through endoscopic, immunohistologic, and molecular PCR modalities.
Detailed description
In order to assess the extent of healing of the biopsy sites, a 12-point scale was developed and validated.
After all of the procedures were complete, this scale was used to measure the effects of the study drugs on the healing of the biopsy-induced ulcers.
Study design
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Naproxen | Active comparator | Drug: Naproxen |
| Aspirin | Experimental | Drug: Aspirin |
| Clopidogrel | Experimental | Drug: Clopidogrel |
| Celecoxib | Experimental | Drug: Celecoxib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent
- Age 18-75
- Use of appropriate form of birth control for women of childbearing potential.
Key exclusion criteria (14 listed)
- H pylori infection
- Use of NSAIDs within 2 weeks prior to start of enrollment
- Use of antacids or H-2 blockers within 2 weeks of enrollment
- Use of PPIs within 30 days of enrollment
- Corticosteroid use within 60 days of enrollment
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 |
|---|---|---|
| NaproxenAlso: naprosyn, naproxen sodium, Aleve, Anaprox1 tablet 500mg BID for 8 days | Drug | Naproxen |
| AspirinAlso: ASA, Bayer1 tablet 81mg QD for 8 days | Drug | Aspirin |
| CelecoxibAlso: Celebrex1 capsule 200mg QD for 8 days | Drug | Celecoxib |
| ClopidogrelAlso: PlavixDay 0: 4 tablets QD for 1 day; Days 1-7: 1 tablet QD for 7 days | Drug | Clopidogrel |
| PlaceboAlso: sugar pill1 capsule BID for 8 days | Drug | Placebo |
Primary outcome
Not reported in the source record.
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 23 Oct 2008.
- Background: PubMed 18224442Desai JC, Sanyal SM, Goo T, Benson AA, Bodian CA, Miller KM, Cohen LB, Aisenberg J. Primary prevention of adverse gastroduodenal effects from short-term use of non-steroidal anti-inflammatory drugs by omeprazole 20 mg in healthy subjects: a randomized, double-blind, placebo-controlled study. Dig Dis Sci. 2008 Aug;53(8):2059-65. doi: 10.1007/s10620-007-0127-4. Epub 2008 Jan 26.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naproxen, Aspirin and Celecoxib in people with Gastroduodenal Ulcer, run by Research Associates of New York, LLP at 1 site in United States.
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 3 inclusion and 14 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 23 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00778193, which also lists 1 linked publication.
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 23 Oct 2008.