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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	4 December 2023
Main ID:	NCT02183168
Date of registration:	04/07/2014
Prospective Registration:	No
Primary sponsor:	Boehringer Ingelheim
Public title:	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
Scientific 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
Date of first enrolment:	July 1, 2001
Target sample size:	192
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/ct2/show/NCT02183168
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 3

Countries of recruitment

Contacts

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Spondylitis, Ankylosing

Intervention(s)

Drug: Meloxicam tablet

Drug: Indomethacin

Drug: Meloxicam suppository

Primary Outcome(s)

Overall assessment of disease activity by the patient on VAS [Time Frame: 6 weeks]

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]

Secondary Outcome(s)

Evaluation of spinal pain by the investigator (verbal rating scale) [Time Frame: 6 weeks]

Total number of study withdrawals [Time Frame: 6 weeks]

Assessment of Patient status with regard to disease condition [Time Frame: 6 weeks]

Number of study withdrawals due to lack of efficacy [Time Frame: 6 weeks]

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]

Assessment of Paracetamol consumption [Time Frame: 6 weeks]

Assessment of Night pain (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]

Duration of morning stiffness [Time Frame: 6 weeks]

Global efficacy assessed by the investigator (verbal rating scale) [Time Frame: 6 weeks]

Secondary ID(s)

107.237

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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