Serum Creatinine Change / Renal Adverse Effect With Use of Non-steroidal Painkillers in Axial Spondyloarthritis Patients

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh (Other)

Overall Status

Completed

CT.gov ID

NCT03582332

Collaborator

(none)

Enrollment

Arms

5.7

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Axial Spondyloarthritis	Drug: Indomethacin SR, 75 Mg Oral Capsule, Extended Release Drug: Indomethacin 25 Mg Oral Capsule Drug: Etoricoxib 90 mg Drug: Etoricoxib 60 mg	Phase 4

Detailed Description

The study had 2 phases. In phase 1, Patients of axial Spondyloarthritis were randomized into 2 groups; group A and group B. they were put on indomethacin 150 mg/day and indomethacin 100 mg/day respectively and were followed up at 3rd week. Those who had normal serum creatinine and responded with the drug were followed up to 24th week. Those who did not respond were excluded from phase 1 and were enrolled in phase 2. Non-responders of indomethacin 150mg and indomethacin 100 mg were put on etoricoxib 90 mg and etoricoxib 60 mg respectively. Again followed up to 24th week.

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Continuous Administration of Different Therapeutic Dosages of Indomethacin and Etoricoxib in the Management of Axial Spondyloarthritis: A Randomized Controlled Trial

Actual Study Start Date :

Jan 2, 2016

Actual Primary Completion Date :

Jun 23, 2016

Actual Study Completion Date :

Jun 23, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A in phase 1 Indomethacin 75 mg, extended release capsule twice daily	Drug: Indomethacin SR, 75 Mg Oral Capsule, Extended Release Indomethacin SR, 75 Mg Oral Capsule, Extended Release orally twice daily Other Names: indomethacin
Active Comparator: Group B in phase 1 Indomethacin 25 mg capsule, 2 capsule twice daily	Drug: Indomethacin 25 Mg Oral Capsule Indomethacin 25 Mg Oral Capsule, 2 capsule orally twice daily Other Names: indomethacin
Active Comparator: Group A in phase 2 Etoricoxib 90 mg once daily	Drug: Etoricoxib 90 mg Etoricoxib 90 mg once daily orally Other Names: Etoricoxib
Active Comparator: Group B in phase 2 Etoricoxib 60 mg once daily	Drug: Etoricoxib 60 mg Etoricoxib 60 mg once daily orally Other Names: Etoricoxib

Outcome Measures

Primary Outcome Measures

Serum creatinine change [3rd week and 24th week]
change in serum creatinine >25% from baseline with use of indomethacin and etoricoxib in Axial Spondyloarthritis patients

Secondary Outcome Measures

Bath Ankyiosing Spodylitis Disease Activity Index (BASDAI) [3rd week and 24th week]
<4 responded to treatment, 4 or more means not responded to treatment
Ankylosing Spondylitis Disease Activity Score (ASDAS) [3rd week and 24th week]
ASDAS: <1.3 between "inactive disease" and "moderate disease activity", <2.1 between "moderate disease activity" and "high disease activity", and >3.5 between "high disease activity" and "very high disease activity"

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Investigators

Principal Investigator: Khandker Mahbub-Uz-Zaman, MD, Resident

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Khandker Mahbub-Uz-Zaman, Resident, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

ClinicalTrials.gov Identifier:

NCT03582332

Other Study ID Numbers:

2015/5965

First Posted:

Jul 11, 2018

Last Update Posted:

Jul 11, 2018

Last Verified:

Jul 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 11, 2018