Arthritis, Juvenile RheumatoidPhase 3NCT00034853
Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)
A Phase 3 study testing meloxicam oral suspension and naproxen oral suspension in people with Arthritis, Juvenile Rheumatoid, run by Boehringer Ingelheim at 37 sites in 4 countries.
Trial summary
To obtain safety, efficacy, pharmacokinetic and dosing information for meloxicam oral suspension in children with Juvenile Rheumatoid Arthritis (JRA) Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Arthritis, Juvenile Rheumatoid
- What is being tested?
- meloxicam oral suspension and naproxen oral suspension
- Type of treatment
- Pill or oral medicine
- How many people
- 180 participants
- Where
- 37 sitesin 4 countries
- Study dates
- Dec 2000to Jun 2003
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of juvenile idiopathic arthritis (JIA) by International League of Associations for Rheumatology (ILAR) criteria; pauciarthritic, extended pauciarthritic, or polyarthritic current course of disease;
- active arthritis of at least 2 joints
- at least 2 other abnormal variables of the 5 remaining core set parameters
- require nonsteroidal anti-inflammatory drugs (NSAIDs)
- children aged 2-17 years
Who cannot join
- systemic course of juvenile idiopathic arthritis
- all rheumatic conditions not included in inclusion criteria; any clinical finding or abnormal clinically relevant lab (not due to JIA) that could interfere with conduct of clinical trial
- weight of 9 kg or less
- pregnancy or breast feeding
- females of childbearing potential who are sexually active and not using adequate contraception for at least 3 mos prior to and for duration of study
- history of bleeding disorder, gastrointestinal bleeding, or cerebrovascular bleeding
Show all 22Show fewer
- peptic ulcer past 6 months
- more than 1 disease modifying anti-rheumatic drug (DMARD) or change in DMARD during 3 months prior
- change corticosteroids during 1 month prior
- systemic corticosteroids greater than 10 mg/d, hydroxychloroquine greater than 10/mg/d, cyclosporine greater than 5 mg/kg/d., methotrexate greater than 15 mg/m2/wk, cytotoxic agents, gold, D-penicilamine, sulfasalazine, glucosamine, and investigational products
- etanercept during 1 month prior; infliximab during 2 months prior; intra-articular corticosteroids during 1 month prior
- patients requiring concomitant other NSAID including topical (excluding ophthalmic)
- requirement for use of other NSAIDs, anticoagulants, phenothiazine, lithium, or ACTH
- insufficient effect or intolerability to naproxen or meloxicam
- known or suspected hypersensitivity to trial meds or their excipients
- requirement of chronic H2 antagonist
- history of asthma, nasal polyps, angioneurotic edema, or urticaria with aspirin or NSAIDs
- planned surgical procedures during study
- investigational drug exposure during this trial or within 30 days (or 6 half lives, whichever greater) prior
- previous participation in this trial
- patients with known drug or alcohol abuse
- patient, parent or legal representative unable to understand and to comply with protocol
Trial locations and contacts
37 sites in 4 countries.
37 sites in 4 countries
United States29 sites
107.235.26 Deparment of Rheumatology
Boston, Massachusetts
107.235.24 The Children's Hospital of Buffalo
Buffalo, New York
107.235.8 Boehringer Ingelheim Investigational Site
Chicago, Illinois
107.235.10 Texas Scottish Rite Hospital
Dallas, Texas
107.235.36 Arthritis Associates Clinical Research of South Florida
Delray Beach, Florida
107.235.4 Boehringer Ingelheim Investigational Site
Denver, Colorado
107.235.32 Arthritis and Osteoporosis Center
Duncansville, Pennsylvania
107.235.12 Boehringer Ingelheim Investigational Site
Hartford, Connecticut
107.235.7 Boehringer Ingelheim Investigational Site
Kansas City, Kansas
107.235.23 Arkansas Children's Hospital
Little Rock, Arkansas
107.235.35 Arthritis and Rheumatic Disease Center
Livingston, New Jersey
107.235.25 University of Louisville
Louisville, Kentucky
107.235.17 Valley Children's Hospital
Madera, California
107.235.21 Miami Children's Hospital
Miami, Florida
107.235.20 Medical College of Wisconsin
Milwaukee, Wisconsin
107.235.16 Children's Hospital - Department of Rheumatology
New Orleans, Louisiana
107.235.19 Columbia Presbyterian Medical Center
New York, New York
107.235.22 Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma
107.235.31 Department of Pediatrics
Omaha, Nebraska
107.235.39 Division of Ambulatory Pediatrics
Providence, Rhode Island
107.235.2 E15 Mayo Clinic
Rochester, Minnesota
107.235.38 Clinical Research Dept #7006
Saint Petersberg, Florida
107.235.1 University of Utah School of Medicine
Salt Lake City, Utah
107.235.37
San Diego, California
107.235.30 Children's Hospital
Seattle, Washington
107.235.18 Washington University School of Medicine
St Louis, Missouri
107.235.9 Boehringer Ingelheim Investigational Site
St Louis, Missouri
107.235.33 Healthcare Research Consultants
Tulsa, Oklahoma
107.235.13 Alfred I. DuPont Hospital for Children
Wilmington, Delaware
Ukraine4 sites
107.235.71 Institute of Children and Adolescents Health
Kharkiv
107.235.70 Children Clinical Hospital No. 1
Kiev
107.235.72 Institute of Pediatrics
Kiev
107.235.73 2nd Children Specialized Clinical Hospital "OHMADIT"
Kiev
Brazil3 sites
107.235.61
Cerqueira César
107.235.62
Santa Cecília
107.235.60
São Paulo
About this study
Official title: A 12 Week Double-blind Randomized Trial, With a 12 Week Open-label Extension, to Investigate the Efficacy and Safety of Meloxicam Oral Suspension Administered Once Daily and Naproxen Oral Suspension Administered Twice Daily in Children With Juvenile Rheumatoid Arthritis
To obtain safety, efficacy, pharmacokinetic and dosing information for meloxicam oral suspension in children with Juvenile Rheumatoid Arthritis (JRA)
- Conditions
- Arthritis, Juvenile Rheumatoid
- Being tested
- meloxicam oral suspension, naproxen oral suspension
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meloxicam oral suspensionDrug
naproxen oral suspensionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder rate by core set of outcome criteria (Juvenile Rheumatoid Arthritis Pediatric 30): global assessment disease activity; functional disability, number joints arthritis, limited motion; erythrocyte sedimentation rate;
Measured: week 12
Secondary outcomes (1)
Individual core set outcome criteria; final global assessment of efficacy; tolerability; AE incidence and intensity; withdrawals; acetaminophen consumption; safety labs: physical examination; hospitalization for gastrointestinal (GI) SAE, GI AE
Measured: weeks 4, 8, 12, 18, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2002 (estimated)
- Study startDec 2000
- Primary completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, Juvenile RheumatoidStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Intervention model
- Parallel groups
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034853
- Sponsor's protocol ID
- 107.235
- Status last verified
- Oct 2013
- First submitted
- 2 May 2002
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Week Double-blind Randomized Trial, With a 12 Week Open-label Extension, to Investigate the Efficacy and Safety of Meloxicam Oral Suspension Administered Once Daily and Naproxen Oral Suspension Administered Twice Daily in Children With Juvenile Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00034853
- Acronym / sponsor ID
- 107.235
- Conditions
- Arthritis, Juvenile Rheumatoid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2000
- Primary completion
- Jun 2003 (actual)
- First posted
- 3 May 2002 (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.
To obtain safety, efficacy, pharmacokinetic and dosing information for meloxicam oral suspension in children with Juvenile Rheumatoid Arthritis (JRA)
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- diagnosis of juvenile idiopathic arthritis (JIA) by International League of Associations for Rheumatology (ILAR) criteria; pauciarthritic, extended pauciarthritic, or polyarthritic current course of disease;
- active arthritis of at least 2 joints
- at least 2 other abnormal variables of the 5 remaining core set parameters
- require nonsteroidal anti-inflammatory drugs (NSAIDs)
- children aged 2-17 years
Key exclusion criteria (22 listed)
- systemic course of juvenile idiopathic arthritis
- all rheumatic conditions not included in inclusion criteria; any clinical finding or abnormal clinically relevant lab (not due to JIA) that could interfere with conduct of clinical trial
- weight of 9 kg or less
- pregnancy or breast feeding
- females of childbearing potential who are sexually active and not using adequate contraception for at least 3 mos prior to and for duration of study
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 |
|---|---|---|
| meloxicam oral suspension | Drug | – |
| naproxen oral suspension | Drug | – |
Primary outcome
Responder rate by core set of outcome criteria (Juvenile Rheumatoid Arthritis Pediatric 30): global assessment disease activity; functional disability, number joints arthritis, limited motion; erythrocyte sedimentation rate;
Time frame: week 12
1 secondary outcome
Individual core set outcome criteria; final global assessment of efficacy; tolerability; AE incidence and intensity; withdrawals; acetaminophen consumption; safety labs: physical examination; hospitalization for gastrointestinal (GI) SAE, GI AE
Time frame: weeks 4, 8, 12, 18, and 24
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 1 Nov 2013.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
37 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing meloxicam oral suspension and naproxen oral suspension in people with Arthritis, Juvenile Rheumatoid, run by Boehringer Ingelheim at 37 sites in 4 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 5 inclusion and 22 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 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Ukraine, Brazil, Mexico. 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 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?
Responder rate by core set of outcome criteria (Juvenile Rheumatoid Arthritis Pediatric 30): global assessment disease activity; functional disability, number joints arthritis, limited motion; erythrocyte sedimentation rate; (time frame: week 12). 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 1 Nov 2013.