Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT03582332
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03582332
Study Brief:
Protocol Section:
NCT03582332