Spondylitis, AnkylosingPhase 3NCT02183168
Evaluation of Efficacy and Safety of Meloxicam Suppository (15mg Daily) and Tablet (15 mg Daily) Compared to Indomethacin Suppository (50 mg Daily) in Patients With Ankylosing Spondylitis
A Phase 3 study testing Meloxicam suppository, Meloxicam tablet and Indomethacin in people with Spondylitis, Ankylosing, run by Boehringer Ingelheim.
Trial summary
Study to assess the efficacy and safety of meloxicam suppository 15 mg once daily, meloxicam tablet 15 mg once daily compared with Indomethacin suppository (50 mg daily) in patients with ankylosing spondylitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylitis, Ankylosing
- What is being tested?
- Meloxicam suppository, Meloxicam tablet and Indomethacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2001to 1 May 2002
- 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
- Active ankylosing spondylitis (pain rated >= 40 mm on a VAS and increased of at least 30% after nonsteroidal anti-inflammatory drugs (NSAIDs) wash-out)), without peripheral arthritis and inflammatory bowel disease
Who cannot join
- none
About this study
Official title: A Randomized, Open Label, 3-arm Evaluation of Efficacy and Safety of Meloxicam Suppository (15mg Daily) and Tablet (15 mg Daily) Compared to Indomethacin Suppository (50 mg Daily) in Patients With Ankylosing Spondylitis
Study to assess the efficacy and safety of meloxicam suppository 15 mg once daily, meloxicam tablet 15 mg once daily compared with Indomethacin suppository (50 mg daily) in patients with ankylosing spondylitis
- Conditions
- Spondylitis, Ankylosing
- Being tested
- Meloxicam suppository, Meloxicam tablet, Indomethacin
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meloxicam suppositoryDrug
Meloxicam tabletDrug
IndomethacinDrug
| Study group | Role | What they receive |
|---|---|---|
| Meloxicam suppository | Experimental | Not described Receives: Drug: Meloxicam suppository |
| Meloxicam tablet | Experimental | Not described Receives: Drug: Meloxicam tablet |
| Indomethacin suppository | Active comparator | Not described Receives: Drug: Indomethacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall pain during the previous 48 hours assessed on a Visual Analogue Scale (VAS)
Measured: 6 weeks
Functional Index of ankylosing spondylitis of Dougados
Measured: 6 weeks
Overall assessment of disease activity by the patient on VAS
Measured: 6 weeks
Secondary outcomes (13)
Overall assessment of disease activity by the investigator on a VAS
Measured: 6 weeks
Global efficacy assessed by the patient (verbal rating scale)
Measured: 6 weeks
Global efficacy assessed by the investigator (verbal rating scale)
Measured: 6 weeks
Duration of morning stiffness
Measured: 6 weeks
Evaluation of spinal pain by the investigator (verbal rating scale)
Measured: 6 weeks
Assessment of Schober test
Measured: 6 weeks
Assessment of Chest expansion
Measured: 6 weeks
Assessment of Fingers - to - floor test
Measured: 6 weeks
Assessment of Night pain (verbal rating scale)
Measured: 6 weeks
Total number of study withdrawals
Measured: 6 weeks
Number of study withdrawals due to lack of efficacy
Measured: 6 weeks
Assessment of Paracetamol consumption
Measured: 6 weeks
Assessment of Patient status with regard to disease condition
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study start1 Jul 2001
- Primary completion1 May 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spondylitis, AnkylosingStudies 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
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183168
- Sponsor's protocol ID
- 107.237
- Status last verified
- Nov 2023
- First submitted
- 4 Jul 2014
- Last updated
- 24 Nov 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, 3-arm Evaluation of Efficacy and Safety of Meloxicam Suppository (15mg Daily) and Tablet (15 mg Daily) Compared to Indomethacin Suppository (50 mg Daily) in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT02183168
- Acronym / sponsor ID
- 107.237
- Conditions
- Spondylitis, Ankylosing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2001 (actual)
- Primary completion
- 1 May 2002 (actual)
- First posted
- 8 Jul 2014 (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.
Study to assess the efficacy and safety of meloxicam suppository 15 mg once daily, meloxicam tablet 15 mg once daily compared with Indomethacin suppository (50 mg daily) in patients with ankylosing spondylitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meloxicam suppository | Experimental | Drug: Meloxicam suppository |
| Meloxicam tablet | Experimental | Drug: Meloxicam tablet |
| Indomethacin suppository | Active comparator | Drug: Indomethacin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Active ankylosing spondylitis (pain rated >= 40 mm on a VAS and increased of at least 30% after nonsteroidal anti-inflammatory drugs (NSAIDs) wash-out)), without peripheral arthritis and inflammatory bowel disease
Key exclusion criteria (1 listed)
- none
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 suppository | Drug | Meloxicam suppository |
| Meloxicam tablet | Drug | Meloxicam tablet |
| Indomethacin | Drug | Indomethacin suppository |
Primary outcome
Overall pain during the previous 48 hours assessed on a Visual Analogue Scale (VAS)
Time frame: 6 weeks
Functional Index of ankylosing spondylitis of Dougados
Time frame: 6 weeks
Overall assessment of disease activity by the patient on VAS
Time frame: 6 weeks
13 secondary outcomes
Overall assessment of disease activity by the investigator on a VAS
Time frame: 6 weeks
Global efficacy assessed by the patient (verbal rating scale)
Time frame: 6 weeks
Global efficacy assessed by the investigator (verbal rating scale)
Time frame: 6 weeks
Duration of morning stiffness
Time frame: 6 weeks
Evaluation of spinal pain by the investigator (verbal rating scale)
Time frame: 6 weeks
Assessment of Schober test
Time frame: 6 weeks
Assessment of Chest expansion
Time frame: 6 weeks
Assessment of Fingers - to - floor test
Time frame: 6 weeks
Assessment of Night pain (verbal rating scale)
Time frame: 6 weeks
Total number of study withdrawals
Time frame: 6 weeks
Number of study withdrawals due to lack of efficacy
Time frame: 6 weeks
Assessment of Paracetamol consumption
Time frame: 6 weeks
Assessment of Patient status with regard to disease condition
Time frame: 6 weeks
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 Nov 2023.
- Related InfoLink provided by the sponsor.
Related trials for Spondylitis, Ankylosing
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Identification of Serum Level of Glutathione Peroxidase 4
Spondyloarthropathy
Not yet recruitingPhase 1
A Study of GKL-006Allo Injection in Patients With Ankylosing Spondylitis
Ankylosing Spondylitis
Active, not recruitingObservational study
Neuropathic Spinal Pain in Ankylosing Spondylitis
Ankylosing Spondylitis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meloxicam suppository, Meloxicam tablet and Indomethacin in people with Spondylitis, Ankylosing, run by Boehringer Ingelheim.
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 1 inclusion and 1 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 Nov 2023. 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?
Overall pain during the previous 48 hours assessed on a Visual Analogue Scale (VAS) (time frame: 6 weeks). The study lists 3 primary outcomes in all. 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 Nov 2023.