OsteoarthritisPhase 2/3NCT01063920
Rates of Gastric Ulcer by Endoscopy in Knee Osteoarthritis Patients Receiving LT-NS001 Versus Naprosyn®
A Phase 2/3 study testing LT-NS001 and Naprosyn® in people with Osteoarthritis, run by Logical Therapeutics at 65 sites in United States.
Trial summary
LT-NS001 is a prodrug of Naproxen, which is inactive as a cox inhibitor while intact and is rapidly metabolized to Naproxen once absorbed. This trial will compare the rate of gastric ulcer by endoscopy over three months in patients with knee osteoarthritis, with patients receiving either LT-NS001 at a dose which… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- LT-NS001 and Naprosyn®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 534 participants
- Where
- 65 sitesUnited States
- Study dates
- Feb 2010to Nov 2010
- Phase
- Phase 2/3
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis of knee
- Appropriate candidate for chronic NSAID therapy due to moderate or severe pain on most days in the 28 days before screening for study.
Who cannot join
- Pregnant/Nursing women
- History of GI bleeding, perforation or obstruction
- A documented symptomatic GI ulcer during past 5 years
- Presence of GI ulcer or more than 2 erosions on screening endoscopy
- Allergy to naproxen (or naproxen intolerance), acetylsalicylic acid, or other NSAID drug
Trial locations and contacts
65 sites in 1 country.
65 sites in 1 country
United States65 sites
Radiant Research-Akron
Akron, Ohio, 44311
Orange County Clinical Trials
Anaheim, California, 92801
SNBL Clinical Pharmacology Center
Baltimore, Maryland, 21201
Delta Research Partners LLC
Bastrop, Louisiana, 71201
Montana Health Research Institute Inc.
Billings, Montana, 59102
Greystone Medical Research, LLC
Birmingham, Alabama, 35242
Theresa Sligh, MD
Burbank, California, 91505
Radiant Research
Chandler, Arizona, 85225
Carolina Digestive Health Associates PA
Charlotte, North Carolina, 28075
Metropolitan Gastroenterolgy Group PC
Chevy Chase, Maryland, 20815
Thomas Schnitzer, MD
Chicago, Illinois, 60611
Consultants for Clinical Research
Cincinnati, Ohio, 45219
Clifton-Wallington Medical Group
Clifton, New Jersey, 07013
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80907
Corsicana Medical Research PLLC
Corsicana, Texas, 75110
Galenos Research
Dallas, Texas, 75251
Physicians Research Options LLC
Draper, Utah, 84020
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Welborn Clinic
Evansville, Indiana, 47710
MediSphere Medical Research Center LLC
Evansville, Indiana, 47714
Arthritis and Osteoporosis Cener of Maryland
Frederick, Maryland, 21702
Eastern Clinical Research Unit
Hialeah, Florida, 33013
Peters Medical Research LLC
High Point, North Carolina, 27262
MidAtlantic Medical Research Centers/Bean Medical Center
Hollywood, Maryland, 20636
Clinical Trial Network
Houston, Texas, 77074
Houston Endoscopy and Research Center
Houston, Texas, 77079
Houston Medical Research Associates
Houston, Texas, 77090
Clinical Research Associates
Huntsville, Alabama, 35801
Nature Coast Clinical Research
Inverness, Florida, 33452
Drug Study Institute
Jupiter, Florida, 33458
Dynamic Clinical Research
Kansas City, Missouri, 64114
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123
Affiliated Clinical Research Inc.
Las Vegas, Nevada, 89144
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205
Torrance Clinical Research
Lomeita, California, 90274
West Gastroenterology Associates
Los Angeles, California, 90045
Venture Resource Group Inc.
Mission, Kansas, 66202
Facey Medical Center
Mission Hills, California, 91345
Research Across America
New York, New York, 10022
Health Research of Oklahoma
Oklahoma City, Oklahoma, 73103
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112
Clinical Research Associates LLC
Oklahoma City, Oklahoma, 73116
Pinnacle Medical Research
Overland Park, Kansas, 66215
Desert Medical Group
Palm Springs, California, 92262
University Clinical Research Inc.
Pembroke Pines, Florida, 33024
Radiant Research
Pinellas Park, Florida, 33781
Accord Clinical Research LLC
Port Orange, Florida, 32129
Keith Klatt, MD
Portland, Oregon, 97739
Wake Research Associates
Raleigh, North Carolina, 27612
Allergy Asthma Immunology of Rochester Research Center
Rochester, New York, 14618
Quality Research Inc.
San Antonio, Texas, 78209
Medical Affiliated Research Center Inc.
San Diego, California, 35801
Cynthia Schaeffer, MD
San Diego, California, 92114
Medical Associates Research Group
San Diego, California, 92123
Miami Research Associates
South Miami, Florida, 33143
Sundance Clinical Research
St Louis, Missouri, 63141
Dedicated Clinical Research Inc.
Surprise, Arizona, 85340
Radiant Research Inc.
Tucson, Arizona, 85710
Adobe Gastroenterology Research, LLC
Tucson, Arizona, 85712
Genova Clinical Research Inc.
Tucson, Arizona, 85741
Arthritis and Osteoporosis Clinic Research Center of Central Texas
Waco, Texas, 76708
Palm Beach Research Center
West Palm Beach, Florida, 33409
Gold Coast Research LLC
Weston, Florida, 33317
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, 80033
About this study
Official title: A Double-Blind, Double-Dummy, Randomized, Active-Comparator, Non-Inferiority Study of LT-NS001 Versus Naprosyn® for Twelve Weeks in Osteoarthritis Patients to Compare Endoscopic Gastric Ulcer Rates
LT-NS001 is a prodrug of Naproxen, which is inactive as a cox inhibitor while intact and is rapidly metabolized to Naproxen once absorbed. This trial will compare the rate of gastric ulcer by endoscopy over three months in patients with knee osteoarthritis, with patients receiving either LT-NS001 at a dose which provides comparable dose levels of Naproxen, or Naprosyn® 500mg (an approved treatment for OA).
Read the detailed description
This is a double-blind, double-dummy, active-comparator study of LT-NS001 versus Naprosyn® for 12 weeks in patients aged 45-80 with osteoarthritis of the knee who are candidates for ongoing NSAID therapy. The percentage of patients with a gastric ulcer by endoscopy (EGD) at week 12 will be compared. EGD is performed at screening and months 1, 2, and 3. Secondary objectives include assessment of pain in the affected knee by WOMAC questionnaire to demonstrate non-inferior pain control using LT-NS001 as compared to Naprosyn®. Information about gastrointestinal pain and tolerability will be collected.
The length of the study is up to 19 weeks with a 2-3 week screening period, a 12 week treatment period and a 4 week post treatment monitoring period.
- Conditions
- Osteoarthritis
- Being tested
- LT-NS001, Naprosyn®
- Keywords
- LT-NS001, Gastric Ulcers, NSAID, Osteoarthritis, Naproxen
- Medical subject headings
- Osteoarthritis, Stomach Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LT-NS001Drug
1200 mg b.i.d. p.o. for 12 weeks
Naprosyn®Drug
500 mg b.i.d. p.o. for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| LT-NS001 | Experimental | LT-NS001 1200 mg b.i.d. p.o. for 12 weeks Receives: Drug: LT-NS001 |
| Naprosyn® | Active comparator | Naprosyn® 500 mg b.i.d for 12 weeks Receives: Drug: Naprosyn® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Ulcer by Endoscopy
Measured: Baseline, Day 29, Day 57 and Day 85
Secondary outcomes (2)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Measured: Screening, Baseline, Days 15, 29, 57 and 85
Population pharmacokinetic analysis will assess the influence of covariates on the absorption/metabolism of LT-NS001 to naproxen
Measured: Two separate days after Day 14, at least two weeks apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 534 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Logical Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Investigators
- Jay L Goldstein, MD, Principal investigator, University of Illinois at Chicago, Department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063920
- Sponsor's protocol ID
- LT-NS001-003
- Status last verified
- Jan 2011
- First submitted
- 29 Jan 2010
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Double-Dummy, Randomized, Active-Comparator, Non-Inferiority Study of LT-NS001 Versus Naprosyn® for Twelve Weeks in Osteoarthritis Patients to Compare Endoscopic Gastric Ulcer Rates
- ClinicalTrials.gov ID
- NCT01063920
- Acronym / sponsor ID
- LT-NS001-003
- Conditions
- Osteoarthritis
- Keywords
- LT-NS001, Gastric Ulcers, NSAID, Osteoarthritis, Naproxen
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 534 participants (estimated)
- Lead sponsor
- Logical TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- Feb 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 5 Feb 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.
LT-NS001 is a prodrug of Naproxen, which is inactive as a cox inhibitor while intact and is rapidly metabolized to Naproxen once absorbed. This trial will compare the rate of gastric ulcer by endoscopy over three months in patients with knee osteoarthritis, with patients receiving either LT-NS001 at a dose which provides comparable dose levels of Naproxen, or Naprosyn® 500mg (an approved treatment for OA).
Detailed description
This is a double-blind, double-dummy, active-comparator study of LT-NS001 versus Naprosyn® for 12 weeks in patients aged 45-80 with osteoarthritis of the knee who are candidates for ongoing NSAID therapy. The percentage of patients with a gastric ulcer by endoscopy (EGD) at week 12 will be compared. EGD is performed at screening and months 1, 2, and 3. Secondary objectives include assessment of pain in the affected knee by WOMAC questionnaire to demonstrate non-inferior pain control using LT-NS001 as compared to Naprosyn®. Information about gastrointestinal pain and tolerability will be collected.
The length of the study is up to 19 weeks with a 2-3 week screening period, a 12 week treatment period and a 4 week post treatment monitoring period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LT-NS001 | Experimental | Drug: LT-NS001LT-NS001 1200 mg b.i.d. p.o. for 12 weeks |
| Naprosyn® | Active comparator | Drug: Naprosyn®Naprosyn® 500 mg b.i.d for 12 weeks |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Osteoarthritis of knee
- Appropriate candidate for chronic NSAID therapy due to moderate or severe pain on most days in the 28 days before screening for study.
Key exclusion criteria (5 listed)
- Pregnant/Nursing women
- History of GI bleeding, perforation or obstruction
- A documented symptomatic GI ulcer during past 5 years
- Presence of GI ulcer or more than 2 erosions on screening endoscopy
- Allergy to naproxen (or naproxen intolerance), acetylsalicylic acid, or other NSAID drug
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 |
|---|---|---|
| LT-NS0011200 mg b.i.d. p.o. for 12 weeks | Drug | LT-NS001 |
| Naprosyn®500 mg b.i.d. p.o. for 12 weeks | Drug | Naprosyn® |
Primary outcome
Gastric Ulcer by Endoscopy
Time frame: Baseline, Day 29, Day 57 and Day 85
2 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Time frame: Screening, Baseline, Days 15, 29, 57 and 85
Population pharmacokinetic analysis will assess the influence of covariates on the absorption/metabolism of LT-NS001 to naproxen
Time frame: Two separate days after Day 14, at least two weeks apart
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 24 Jan 2011.
Related trials for Osteoarthritis
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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.
Jay L Goldstein, MD principal investigator
University of Illinois at Chicago, Department of Medicine
65 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing LT-NS001 and Naprosyn® in people with Osteoarthritis, run by Logical Therapeutics at 65 sites 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 2 inclusion and 5 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 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Gastric Ulcer by Endoscopy (time frame: Baseline, Day 29, Day 57 and Day 85). 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 24 Jan 2011.