- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02183168
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
July 4, 2014 updated by: Boehringer Ingelheim
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
192
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Meloxicam suppository
|
|
Experimental: Meloxicam tablet
|
|
Active Comparator: Indomethacin suppository
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall pain during the previous 48 hours assessed on a Visual Analogue Scale (VAS)
Time Frame: 6 weeks
|
6 weeks
|
Functional Index of ankylosing spondylitis of Dougados
Time Frame: 6 weeks
|
6 weeks
|
Overall assessment of disease activity by the patient on VAS
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall assessment of disease activity by the investigator on a VAS
Time Frame: 6 weeks
|
6 weeks
|
Global efficacy assessed by the patient (verbal rating scale)
Time Frame: 6 weeks
|
6 weeks
|
Global efficacy assessed by the investigator (verbal rating scale)
Time Frame: 6 weeks
|
6 weeks
|
Duration of morning stiffness
Time Frame: 6 weeks
|
6 weeks
|
Evaluation of spinal pain by the investigator (verbal rating scale)
Time Frame: 6 weeks
|
6 weeks
|
Assessment of Schober test
Time Frame: 6 weeks
|
6 weeks
|
Assessment of Chest expansion
Time Frame: 6 weeks
|
6 weeks
|
Assessment of Fingers - to - floor test
Time Frame: 6 weeks
|
6 weeks
|
Assessment of Night pain (verbal rating scale)
Time Frame: 6 weeks
|
6 weeks
|
Total number of study withdrawals
Time Frame: 6 weeks
|
6 weeks
|
Number of study withdrawals due to lack of efficacy
Time Frame: 6 weeks
|
6 weeks
|
Assessment of Paracetamol consumption
Time Frame: 6 weeks
|
6 weeks
|
Assessment of Patient status with regard to disease condition
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2001
Primary Completion (Actual)
May 1, 2002
Study Registration Dates
First Submitted
July 4, 2014
First Submitted That Met QC Criteria
July 4, 2014
First Posted (Estimate)
July 8, 2014
Study Record Updates
Last Update Posted (Estimate)
July 8, 2014
Last Update Submitted That Met QC Criteria
July 4, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Joint Diseases
- Musculoskeletal Diseases
- Arthritis
- Spinal Diseases
- Bone Diseases
- Spondylarthropathies
- Bone Diseases, Infectious
- Ankylosis
- Spondylitis
- Spondylarthritis
- Spondylitis, Ankylosing
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Reproductive Control Agents
- Cyclooxygenase 2 Inhibitors
- Gout Suppressants
- Tocolytic Agents
- Indomethacin
- Meloxicam
Other Study ID Numbers
- 107.237
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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