OsteoarthritisPhase 3NCT00175032
A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin
A Phase 3 study testing Lansoprazole and naproxen and aspirin and Celecoxib and aspirin in people with Osteoarthritis and Peptic Ulcer, run by Takeda.
Trial summary
The purpose of this study is to compare the gastroduodenal ulceration rate, gastrointestinal complication rate and non-steroidal anti-inflammatory drug-associated dyspepsia between lansoprazole, naproxen and celecoxib, taken once daily (QD) or twice daily (BID), in participants with osteoarthritis taking low dose… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Peptic Ulcer
- What is being tested?
- Lansoprazole and naproxen and aspirin and Celecoxib and aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,045 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Jul 2004
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must require the chronic use of a non-steroidal anti-inflammatory drug for the treatment of osteoarthritis.
- Must be taking daily aspirin for cardiovascular prophylaxis.
- Clinical Laboratory values within normal limits for this population
Who cannot join
- History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
- Evidence of uncontrolled, clinically significant disease.
- History of cancer within the past 5 years.
- Presence of gastroduodenal ulcers, esophageal ulcer or >= 10 gastroduodenal erosions during the screening endoscopy. Known history of gastroduodenal ulcer or bleeding within the past year. Esophageal stricture requiring dilatation.
- Presence of Barrett's esophagus with dysplastic changes.
- Systemic disease affecting the esophagus or a history of caustic or physiochemical trauma or irradiation to the esophagus.
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- Sero-tests positive for H. pylori.
- Evidence of Zollinger-Ellison syndrome, esophageal varices, cholecystitis, or pancreaticobiliary tract disease.
- Requires treatment with an excluded medication such as proton pump inhibitors, histamine H2 receptor antagonists, antacids, corticosteroids, lithium, fluconazole, misoprostol, probenecid, methotrexate, anticoagulants, St. John's wart, dong quai, feverfew, garlic, ginger, horse chestnut, red clover or white willow supplements or bisphosphonates.
About this study
Official title: A Randomized, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of Lansoprazole 30 mg QD and Naproxen 500 mg BID Versus Celecoxib 200 mg QD in Risk Reduction of Non Steroidal Anti-Inflammatory-Associated Ulcers in Osteoarthritis Subjects Taking Low Dose Aspirin
The purpose of this study is to compare the gastroduodenal ulceration rate, gastrointestinal complication rate and non-steroidal anti-inflammatory drug-associated dyspepsia between lansoprazole, naproxen and celecoxib, taken once daily (QD) or twice daily (BID), in participants with osteoarthritis taking low dose aspirin.
Read the detailed description
This study was designed to compare the effectiveness of reducing the incidence of gastroduodenal ulcers between lansoprazole 30mg QD + naproxen 500mg BID vs celecoxib 200mg QD in subjects with osteoarthritis taking low dose aspirin. Approximately 100 sites across the U.S. will enroll subjects with normal endoscopic findings and negative H.pylori. The duration of the study will be a maximum of 14 weeks including a screening period of up to 2 weeks and a 12 week treatment period. Gelusil will be provided for dyspepsia symptom rescue.
- Conditions
- Osteoarthritis, Peptic Ulcer
- Being tested
- Lansoprazole and naproxen and aspirin, Celecoxib and aspirin
- Keywords
- Low dose aspirin, Peptic Ulcer, gastric ulcer, duodenal ulcer, NSAIDs
- Medical subject headings
- Osteoarthritis, Peptic Ulcer, Stomach Ulcer, Duodenal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lansoprazole and naproxen and aspirinDrug
Lansoprazole 30 mg, capsules, orally once daily; Naproxen 500 mg, capsules, orally, twice daily; and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks.
Celecoxib and aspirinDrug
Celecoxib 200 mg, capsules, orally once daily and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lansoprazole 30 mg QD + Naproxen 500 mg BID | Experimental | (and added aspirin) Receives: Drug: Lansoprazole and naproxen and aspirin |
| Celecoxib 200 mg QD | Active comparator | (and added aspirin) Receives: Drug: Celecoxib and aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastroduodenal ulcers at final visit
Measured: Week 12
Secondary outcomes (6)
Proportion of subjects with GI complications (GI bleeding, perforation and gastric outlet obstruction)
Measured: Week 12
Severity of each dyspepsia symptom (abdominal pain, nausea, vomiting, heartburn, fullness, and belching) and combined dyspepsia scores.
Measured: Weeks 4,8, and 12
Proportion of subjects with dyspepsia at weeks 4, 8, and 12 that did not have dyspepsia at baseline.
Measured: Weeks 4,8, and 12
Proportion of subjects without dyspepsia at weeks 4, 8, and 12 who had dyspepsia at baseline.
Measured: Weeks 4, 8, and 12
Scores of each SODA scale (pain intensity, non-pain symptoms, and satisfaction) for subjects with dyspepsia.
Measured: Weeks 4, 8, and 12
The change from baseline SODA scale for subjects with dyspepsia at baseline.
Measured: Weeks 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionJul 2004
- Study completionJul 2004
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 OsteoarthritisStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,045 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175032
- Sponsor's protocol ID
- LAN-0003-0041
- Other IDs
- U1111-1114-2275
- Status last verified
- Jul 2010
- First submitted
- 12 Sep 2005
- Last updated
- 22 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Goldstein JL, Cryer B, Amer F, Hunt B. Celecoxib plus aspirin versus naproxen and lansoprazole plus aspirin: a randomized, double-blind, endoscopic trial. Clin Gastroenterol Hepatol. 2007 Oct;5(10):1167-74. doi: 10.1016/j.cgh.2007.06.009.
PubMed 17916545
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of Lansoprazole 30 mg QD and Naproxen 500 mg BID Versus Celecoxib 200 mg QD in Risk Reduction of Non Steroidal Anti-Inflammatory-Associated Ulcers in Osteoarthritis Subjects Taking Low Dose Aspirin
- ClinicalTrials.gov ID
- NCT00175032
- Acronym / sponsor ID
- LAN-0003-0041
- Conditions
- Osteoarthritis, Peptic Ulcer
- Keywords
- Low dose aspirin, Peptic Ulcer, gastric ulcer, duodenal ulcer, NSAIDs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,045 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jul 2004 (actual)
- First posted
- 15 Sep 2005 (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.
The purpose of this study is to compare the gastroduodenal ulceration rate, gastrointestinal complication rate and non-steroidal anti-inflammatory drug-associated dyspepsia between lansoprazole, naproxen and celecoxib, taken once daily (QD) or twice daily (BID), in participants with osteoarthritis taking low dose aspirin.
Detailed description
This study was designed to compare the effectiveness of reducing the incidence of gastroduodenal ulcers between lansoprazole 30mg QD + naproxen 500mg BID vs celecoxib 200mg QD in subjects with osteoarthritis taking low dose aspirin. Approximately 100 sites across the U.S. will enroll subjects with normal endoscopic findings and negative H.pylori. The duration of the study will be a maximum of 14 weeks including a screening period of up to 2 weeks and a 12 week treatment period. Gelusil will be provided for dyspepsia symptom rescue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lansoprazole 30 mg QD + Naproxen 500 mg BID | Experimental | Drug: Lansoprazole and naproxen and aspirin(and added aspirin) |
| Celecoxib 200 mg QD | Active comparator | Drug: Celecoxib and aspirin(and added aspirin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must require the chronic use of a non-steroidal anti-inflammatory drug for the treatment of osteoarthritis.
- Must be taking daily aspirin for cardiovascular prophylaxis.
- Clinical Laboratory values within normal limits for this population
Key exclusion criteria (9 listed)
- History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
- Evidence of uncontrolled, clinically significant disease.
- History of cancer within the past 5 years.
- Presence of gastroduodenal ulcers, esophageal ulcer or >= 10 gastroduodenal erosions during the screening endoscopy. Known history of gastroduodenal ulcer or bleeding within the past year. Esophageal stricture requiring dilatation.
- Presence of Barrett's esophagus with dysplastic changes.
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 |
|---|---|---|
| Lansoprazole and naproxen and aspirinLansoprazole 30 mg, capsules, orally once daily; Naproxen 500 mg, capsules, orally, twice daily; and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks. | Drug | Lansoprazole 30 mg QD + Naproxen 500 mg BID |
| Celecoxib and aspirinCelecoxib 200 mg, capsules, orally once daily and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks. | Drug | Celecoxib 200 mg QD |
Primary outcome
Gastroduodenal ulcers at final visit
Time frame: Week 12
6 secondary outcomes
Proportion of subjects with GI complications (GI bleeding, perforation and gastric outlet obstruction)
Time frame: Week 12
Severity of each dyspepsia symptom (abdominal pain, nausea, vomiting, heartburn, fullness, and belching) and combined dyspepsia scores.
Time frame: Weeks 4,8, and 12
Proportion of subjects with dyspepsia at weeks 4, 8, and 12 that did not have dyspepsia at baseline.
Time frame: Weeks 4,8, and 12
Proportion of subjects without dyspepsia at weeks 4, 8, and 12 who had dyspepsia at baseline.
Time frame: Weeks 4, 8, and 12
Scores of each SODA scale (pain intensity, non-pain symptoms, and satisfaction) for subjects with dyspepsia.
Time frame: Weeks 4, 8, and 12
The change from baseline SODA scale for subjects with dyspepsia at baseline.
Time frame: Weeks 4, 8, and 12
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 Jul 2010.
- Results publication: PubMed 17916545Goldstein JL, Cryer B, Amer F, Hunt B. Celecoxib plus aspirin versus naproxen and lansoprazole plus aspirin: a randomized, double-blind, endoscopic trial. Clin Gastroenterol Hepatol. 2007 Oct;5(10):1167-74. doi: 10.1016/j.cgh.2007.06.009.
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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.
Medical Director study director
Takeda
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lansoprazole and naproxen and aspirin and Celecoxib and aspirin in people with Osteoarthritis and Peptic Ulcer, run by Takeda.
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 9 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 Jul 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Gastroduodenal ulcers at final visit (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00175032, 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 22 Jul 2010.