Status:
COMPLETED
A Trial of TD0019 in Treatment of Cervical Scapulohumeral Syndrome
Lead Sponsor:
Sao Thai Duong Joint Stock Company
Collaborating Sponsors:
Big Leap Research
Conditions:
Syndrome Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Cervical scapulohumeral syndrome, which is also called scapulohumeral syndrome or cervical radiculopathy is a group of syndromes related to cervical spine disorders with disfunctional nerves and witho...
Detailed Description
Cervical scapulohumeral syndrome, which is also called scapulohumeral syndrome or cervical radiculopathy is a group of syndromes related to cervical spine disorders with disfunctional nerves and witho...
Eligibility Criteria
Inclusion
- Subject must meet all below criteria to be enrolled:
- Subjects diagnosed with cervical scapulohumeral syndrome according to the Guideline of Vietnam MOH 2014
- Age \> 18 at time of signing ICF, male or female.
- No contraindications with oral NSAIDs.
- Agree and and sign in the ICF
Exclusion
- Subjects will be excluded in the trial if any of the below are met:
- Hypersensitivity to any subtances of TD0019 or any NSAIDs.
- Pregnant or lactating.
- Currently having surgical indications.
- Movement disorders, diabetes, myasthenia, alcoholism
- Other conditions asseted by the investigator that are not eligible to be enrolled.
- Cervical scapulohumeral syndrome caused by tumor, infection, hypertension, physical injured.
- Arrhythmia, hypertension.
- Hypertensitivity to meloxicam or its excipients.
- Cross - hypertensitivity to aspirin or other NSAIDs.
- Peptic ulcer
- Severe liver failure
- Severe renal failure without dialysis.
- Gastrointestinal hemorrhage, recent brain hemorrhage.
- Uncontrolled heart failure.
- Alcoholism, movement disorders, diabetes, muscular dystrophy.
Key Trial Info
Start Date :
August 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2018
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03845959
Start Date
August 30 2017
End Date
February 20 2018
Last Update
February 19 2019
Active Locations (1)
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1
National Hospital of Traditional Medicine
Hanoi, Vietnam