NCT02183168

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P25-P50 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2002

Completed
12.2 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

July 4, 2014

Last Update Submit

November 22, 2023

Conditions

Spondylitis, Ankylosing

Outcome Measures

Primary Outcomes (3)

  • Overall pain during the previous 48 hours assessed on a Visual Analogue Scale (VAS)

    6 weeks

  • Functional Index of ankylosing spondylitis of Dougados

    6 weeks

  • Overall assessment of disease activity by the patient on VAS

    6 weeks

Secondary Outcomes (13)

  • Overall assessment of disease activity by the investigator on a VAS

    6 weeks

  • Global efficacy assessed by the patient (verbal rating scale)

    6 weeks

  • Global efficacy assessed by the investigator (verbal rating scale)

    6 weeks

  • Duration of morning stiffness

    6 weeks

  • Evaluation of spinal pain by the investigator (verbal rating scale)

    6 weeks

  • +8 more secondary outcomes

Study Arms (3)

Meloxicam suppository

EXPERIMENTAL
Drug: Meloxicam suppository

Meloxicam tablet

EXPERIMENTAL
Drug: Meloxicam tablet

Indomethacin suppository

ACTIVE COMPARATOR
Drug: Indomethacin

Interventions

Meloxicam suppositoryDRUG
Meloxicam suppository
Meloxicam tabletDRUG
Meloxicam tablet
IndomethacinDRUG
Indomethacin suppository

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

MeloxicamIndomethacin

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

ThiazinesSulfur CompoundsOrganic ChemicalsThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2014

First Posted

July 8, 2014

Study Start

July 1, 2001

Primary Completion

May 1, 2002

Last Updated

November 24, 2023

Record last verified: 2023-11