OsteoarthritisPhase 3NCT00239395
A Study to Compare Meloxicam IM Once Daily and Meloxicam Administered Orally Once Daily in Patients With Osteoarthritis
A Phase 3 study testing Meloxicam ampoule and Meloxicam tablet in people with Osteoarthritis, run by Boehringer Ingelheim at 8 sites in China.
Trial summary
The objective of this trial was to assess the efficacy and safety of 7.5 mg meloxicam i.m. once daily compared with 7.5 mg meloxicam tablets once daily p.o. in patients with osteoarthritis over a time period of 7 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Meloxicam ampoule and Meloxicam tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 168 participants
- Where
- 8 sitesChina
- Study dates
- Jul 2004to Dec 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
- Male or female aged 18 years or above
- Patients suffering from acute and painful exacerbation of osteoarthritis of the hip or knee.
- The diagnosis must be based on
- clinical signs and symptoms or
- x-ray diagnosis plus clinical signs and symptoms
- Assessment of pain on active movement (by the patient) must exceed 40 mm on a 100 mm visual analogue scale (VAS)
- Symptoms of OA requiring administration of NSAIDs
- Willingness and ability to provide written informed consent.
Who cannot join
- Known or suspected hypersensitivity to the trial drugs or their excipients, analgesics, antipyretics or NSAIDs
- Any clinical evidence of active peptic ulceration during the last six months
- Pregnancy or breastfeeding (precaution : attention should be drawn to reports that NSAIDs were reported to decrease the effectivity of intrauterine devices)
- Asthma, nasal polyps, angioneurotic oedema or urticaria following the administration of aspirin or NSAIDs
- Concomitant treatment with anti-coagulants (including heparin), lithium
- Concomitant administration of other NSAIDs or analgesic agents (except paracetamol up to 4g/day)
Show all 22Show fewer
- Administration of any NSAID during the last 2 days (3 days for any oxicam) prior to the first administration of the trial drug
- Concomitant treatment with an oral corticosteroid initiated or with an altered dose over the previous month
- Parenteral or intraarticular administration of corticosteroids in the previous month
- Any i.m. injection during the previous 7 days
- Any contra-indication to i.m. injections
- Clinical evidence of or known severe cardiac, hepatic, renal, metabolic, haematological disease, mental disturbance, ulcerative colitis
- Any other rheumatological or non-rheumatological disease that could interfere with the evaluation of efficacy and safety
- Serum creatinine 125 % of the upper limit of normal range ; aspartate transferase (AST/SGOT) and/or alkaline transferase (ALT/SGPT) 200 % of the upper limit of normal range
- Platelet count < 100,000/mm3 ; leucocytes count < 3,000/mm3
- Synovectomy in the previous month or during the trial
- Participation in another clinical trial during this study or during the previous month
- Previous participation in this trial
- Patient unable to comply with the protocol
- Concomitant therapy with specific symptomatic drug of OA, such as chondroitin sulphate, diacerhein, initiated or with an altered dose over the previous 3 months.
- Intraarticular administration of hyaluronic acid in the previous month
- Patients where physiotherapy will be changed throughout the study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
People's Hospital, Beijing University
Beijing, 100044
Beijing Xuan Wu Hospital
Beijing, 100050
1st Affiliated, Anhui Medical University
Hefei City, Anhui Province, 230022
Qilu Hospital, Shang Dong University
Nanzhou, 250012
Shanghai Renji Hospital
Shanghai, 200001
Shanghai Zhongshan Hospital
Shanghai, 200032
Shanghai Guanghai Hospital
Shanghai, 200052
Shanghai Changhai Hospital
Shanghai, 200443
About this study
Official title: A Randomised, Open-labelled Study to Compare the Efficacy and Safety of Meloxicam 7.5 mg IM Ampoules Once Daily and Meloxicam 7.5 mg Tablets Administered Orally Once Daily Over a Period of 7 Days in Patients With Osteoarthritis (OA)
The objective of this trial was to assess the efficacy and safety of 7.5 mg meloxicam i.m. once daily compared with 7.5 mg meloxicam tablets once daily p.o. in patients with osteoarthritis over a time period of 7 days.
Read the detailed description
This was a randomized (1:1), open-label, multi-center, active-control, parallel-group study to compare the efficacy of 7.5 mg meloxicam i.m. once daily compared with 7.5 mg meloxicam tablets once daily p.o. in patients with osteoarthritis over a time period of 7 days.
The primary endpoint: Pain on active movement,
The secondary endpoint:
- Pain at rest
- Patient status with regard to change of arthritic condition assessed by the patient/investigator
- Patient's assessment of arthritic condition
- Onset of action
- Time to maximum pain relief
- Paracetamol consumption
- Withdrawals due to inadequate efficacy
- Final global assessment of efficacy by the patient/investigator
Safety endpoints
- Local tolerability assessment of the injections by the patient/investigator
- Patient's /Investigator's assessment of overall tolerability
- Number, nature and severity of adverse events
- Laboratory investigations
- Withdrawals due to safety reasons
Patients eligible for the trial who met all inclusion and exclusion criteria and who gave their informed consent were randomized to one of two treatment groups (i.e. meloxicam ampoule or meloxicam tablet).
The study period totaled 8-14 days included screening, randomisation, study drug administration, and 7-day follow-up. The relevant assessment were performed on the day of randomisation and 7-day follow up.
Study Hypothesis:
The null hypothesis of interest is that the primary endpoint for meloxicam ampoule is inferior to oral meloxicam. The alternative is that meloxicam ampoule is noninferior to the oral meloxicam .
Comparison(s):
The primary endpoint of the study was to assess pain on active movement by VAS prior and after the treatment.
- Conditions
- Osteoarthritis
- Being tested
- Meloxicam ampoule, Meloxicam tablet
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meloxicam ampouleDrug
Meloxicam tabletDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on active movement by VAS.
Measured: day 0, day 7
Secondary outcomes (13)
Pain at rest
Measured: up to 7 days
Patient status with regard to change of arthritic condition
Measured: up to 7 days
Withdrawals due to inadequate efficacy
Measured: up to 7 days
Onset of Analgesic action
Measured: up to 7 days
Time to maximum pain relief
Measured: up to 7 days
Paracetamol consumption
Measured: up to 7 days
Final global assessment of efficacy by patient
Measured: up to 7 days
Final global assessment of efficacy by investigator
Measured: up to 7 days
Assessment of local tolerability
Measured: up to 7 days
Nature and severity of adverse events
Measured: up to 7 days
Change in other laboratory investigations
Measured: up to 7 days
Withdrawals due to safety reasons
Measured: up to 7 days
Patient's and investigator's assessment of overall tolerability
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startJul 2004
- Primary completionDec 2004
- Study completionDec 2004
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.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239395
- Sponsor's protocol ID
- 107.265
- Status last verified
- Oct 2013
- First submitted
- 13 Oct 2005
- 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 Randomised, Open-labelled Study to Compare the Efficacy and Safety of Meloxicam 7.5 mg IM Ampoules Once Daily and Meloxicam 7.5 mg Tablets Administered Orally Once Daily Over a Period of 7 Days in Patients With Osteoarthritis (OA)
- ClinicalTrials.gov ID
- NCT00239395
- Acronym / sponsor ID
- 107.265
- Conditions
- Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004
- First posted
- 17 Oct 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 objective of this trial was to assess the efficacy and safety of 7.5 mg meloxicam i.m. once daily compared with 7.5 mg meloxicam tablets once daily p.o. in patients with osteoarthritis over a time period of 7 days.
Detailed description
This was a randomized (1:1), open-label, multi-center, active-control, parallel-group study to compare the efficacy of 7.5 mg meloxicam i.m. once daily compared with 7.5 mg meloxicam tablets once daily p.o. in patients with osteoarthritis over a time period of 7 days.
The primary endpoint: Pain on active movement,
The secondary endpoint:
- Pain at rest
- Patient status with regard to change of arthritic condition assessed by the patient/investigator
- Patient's assessment of arthritic condition
- Onset of action
- Time to maximum pain relief
- Paracetamol consumption
- Withdrawals due to inadequate efficacy
- Final global assessment of efficacy by the patient/investigator
Safety endpoints
- Local tolerability assessment of the injections by the patient/investigator
- Patient's /Investigator's assessment of overall tolerability
- Number, nature and severity of adverse events
- Laboratory investigations
- Withdrawals due to safety reasons
Patients eligible for the trial who met all inclusion and exclusion criteria and who gave their informed consent were randomized to one of two treatment groups (i.e. meloxicam ampoule or meloxicam tablet).
The study period totaled 8-14 days included screening, randomisation, study drug administration, and 7-day follow-up. The relevant assessment were performed on the day of randomisation and 7-day follow up.
Study Hypothesis:
The null hypothesis of interest is that the primary endpoint for meloxicam ampoule is inferior to oral meloxicam. The alternative is that meloxicam ampoule is noninferior to the oral meloxicam .
Comparison(s):
The primary endpoint of the study was to assess pain on active movement by VAS prior and after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female aged 18 years or above
- Patients suffering from acute and painful exacerbation of osteoarthritis of the hip or knee.
- The diagnosis must be based on
- clinical signs and symptoms or
- x-ray diagnosis plus clinical signs and symptoms
Key exclusion criteria (22 listed)
- Known or suspected hypersensitivity to the trial drugs or their excipients, analgesics, antipyretics or NSAIDs
- Any clinical evidence of active peptic ulceration during the last six months
- Pregnancy or breastfeeding (precaution : attention should be drawn to reports that NSAIDs were reported to decrease the effectivity of intrauterine devices)
- Asthma, nasal polyps, angioneurotic oedema or urticaria following the administration of aspirin or NSAIDs
- Concomitant treatment with anti-coagulants (including heparin), lithium
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 ampoule | Drug | – |
| Meloxicam tablet | Drug | – |
Primary outcome
Pain on active movement by VAS.
Time frame: day 0, day 7
13 secondary outcomes
Pain at rest
Time frame: up to 7 days
Patient status with regard to change of arthritic condition
Time frame: up to 7 days
Withdrawals due to inadequate efficacy
Time frame: up to 7 days
Onset of Analgesic action
Time frame: up to 7 days
Time to maximum pain relief
Time frame: up to 7 days
Paracetamol consumption
Time frame: up to 7 days
Final global assessment of efficacy by patient
Time frame: up to 7 days
Final global assessment of efficacy by investigator
Time frame: up to 7 days
Assessment of local tolerability
Time frame: up to 7 days
Nature and severity of adverse events
Time frame: up to 7 days
Change in other laboratory investigations
Time frame: up to 7 days
Withdrawals due to safety reasons
Time frame: up to 7 days
Patient's and investigator's assessment of overall tolerability
Time frame: up to 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 1 Nov 2013.
- Related InfoLink provided by the sponsor.
Related trials for Osteoarthritis
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Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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 Coordinator study chair
Boehringer Ingelheim Shanghai
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meloxicam ampoule and Meloxicam tablet in people with Osteoarthritis, run by Boehringer Ingelheim at 8 sites in China.
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 8 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 8 sites in China. 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?
Pain on active movement by VAS. (time frame: day 0, day 7). 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.