NCT03582332

Brief Summary

2 Non-steroidal anti-inflammatory drugs (NSAIDs), indomethacin and etoricoxib were prescribed sequentially in Axial Spondyloarthritis patients according to the internationally accepted guidelines to determine serum creatinine change with NSAIDs use.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_4

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
Last Updated

July 11, 2018

Status Verified

July 1, 2018

Enrollment Period

6 months

First QC Date

March 12, 2018

Last Update Submit

July 9, 2018

Conditions

Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

  • Serum creatinine change

    change in serum creatinine \>25% from baseline with use of indomethacin and etoricoxib in Axial Spondyloarthritis patients

    3rd week and 24th week

Secondary Outcomes (2)

  • Bath Ankyiosing Spodylitis Disease Activity Index (BASDAI)

    3rd week and 24th week

  • Ankylosing Spondylitis Disease Activity Score (ASDAS)

    3rd week and 24th week

Study Arms (4)

Group A in phase 1

ACTIVE COMPARATOR

Indomethacin 75 mg, extended release capsule twice daily

Drug: Indomethacin SR, 75 Mg Oral Capsule, Extended Release

Group B in phase 1

ACTIVE COMPARATOR

Indomethacin 25 mg capsule, 2 capsule twice daily

Drug: Indomethacin 25 Mg Oral Capsule

Group A in phase 2

ACTIVE COMPARATOR

Etoricoxib 90 mg once daily

Drug: Etoricoxib 90 mg

Group B in phase 2

ACTIVE COMPARATOR

Etoricoxib 60 mg once daily

Drug: Etoricoxib 60 mg

Interventions

Indomethacin SR, 75 Mg Oral Capsule, Extended ReleaseDRUG

Indomethacin SR, 75 Mg Oral Capsule, Extended Release orally twice daily

Also known as: indomethacin
Group A in phase 1
Indomethacin 25 Mg Oral CapsuleDRUG

Indomethacin 25 Mg Oral Capsule, 2 capsule orally twice daily

Also known as: indomethacin
Group B in phase 1
Etoricoxib 90 mgDRUG

Etoricoxib 90 mg once daily orally

Also known as: Etoricoxib
Group A in phase 2
Etoricoxib 60 mgDRUG

Etoricoxib 60 mg once daily orally

Also known as: Etoricoxib
Group B in phase 2

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • SpA (axial) patients according to Assessment of Spondyloarthritis International Society (ASAS) criteria with BASDAI \> 4

You may not qualify if:

  • Inadequate response to therapeutic dose of indomethacin or etoricoxib, taken for at least 2 weeks continuously
  • Abnormal serum creatinine : serum creatinine \>1.3 mg/dl
  • Abnormal SGPT: SGPT \> 40 U/L
  • Hypertension: Systolic blood pressure \> 140 mm Hg and/ or diastolic blood pressure \>90 mm Hg or on anti-hypertensive drug
  • Dyspepsia or active peptic ulcer disease : upper abdominal discomfort or upper abdominal pain related with food or peptic ulcer disease diagnosed by upper gastrointestinal endoscopy
  • Diabetes mellitus: abnormal random plasma glucose or diagnosed case of diabetes mellitus
  • Ischemic heart disease: history of angina or ECG changes suggestive of ischemic heart disease
  • Active congestive heart failure: pedal edema with tender hepatomegaly with raised JVP or diastolic dysfunction on echocardiography
  • Asthma: diagnosed case of asthma or rhonchi on chest auscultation
  • Bleeding problems: having a history of prolonged bleeding
  • Pregnancy: missed period followed by positive pregnancy test
  • Simultaneous use with certain medications such as warfarin, phenytoin, cyclosporine, probenecid, lithium, digoxin, ACE inhibitor, thiazide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Axial Spondyloarthritis

Interventions

CapsulesIndomethacinEtoricoxib

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical PreparationsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsSulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Khandker Mahbub-Uz-Zaman, MD

    Resident

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

March 12, 2018

First Posted

July 11, 2018

Study Start

January 2, 2016

Primary Completion

June 23, 2016

Study Completion

June 23, 2016

Last Updated

July 11, 2018

Record last verified: 2018-07