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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

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ClinicalTrials.gov Identifier: NCT02183168
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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

Condition or disease Intervention/treatment Phase
Spondylitis, Ankylosing Drug: Meloxicam suppository Drug: Meloxicam tablet Drug: Indomethacin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2001
Actual Primary Completion Date : May 2002


Arm Intervention/treatment
Experimental: Meloxicam suppository Drug: Meloxicam suppository
Experimental: Meloxicam tablet Drug: Meloxicam tablet
Active Comparator: Indomethacin suppository Drug: Indomethacin



Primary Outcome Measures :
  1. Overall pain during the previous 48 hours assessed on a Visual Analogue Scale (VAS) [ Time Frame: 6 weeks ]
  2. Functional Index of ankylosing spondylitis of Dougados [ Time Frame: 6 weeks ]
  3. Overall assessment of disease activity by the patient on VAS [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Overall assessment of disease activity by the investigator on a VAS [ Time Frame: 6 weeks ]
  2. Global efficacy assessed by the patient (verbal rating scale) [ Time Frame: 6 weeks ]
  3. Global efficacy assessed by the investigator (verbal rating scale) [ Time Frame: 6 weeks ]
  4. Duration of morning stiffness [ Time Frame: 6 weeks ]
  5. Evaluation of spinal pain by the investigator (verbal rating scale) [ Time Frame: 6 weeks ]
  6. Assessment of Schober test [ Time Frame: 6 weeks ]
  7. Assessment of Chest expansion [ Time Frame: 6 weeks ]
  8. Assessment of Fingers - to - floor test [ Time Frame: 6 weeks ]
  9. Assessment of Night pain (verbal rating scale) [ Time Frame: 6 weeks ]
  10. Total number of study withdrawals [ Time Frame: 6 weeks ]
  11. Number of study withdrawals due to lack of efficacy [ Time Frame: 6 weeks ]
  12. Assessment of Paracetamol consumption [ Time Frame: 6 weeks ]
  13. Assessment of Patient status with regard to disease condition [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
Criteria

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


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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183168    
Other Study ID Numbers: 107.237
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Indomethacin
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors