Health Condition 1: T07- Unspecified multiple injuries
Conditions
Interventions
Intervention1: CRPL/CT/19/004: To Evaluate the Safety Tolerability and Efficacy of FDC of Trypsin Chymotrypsin 50000 AU plus Aceclofenac 100 mg plus Paracetamol 325 mg Tablets in Subjects for the trea
Sponsors
Synokem Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged between 18 to 65 (both inclusive) years. 2. Patients with acute painful traumatic condition of orthopaedics such as sprains of ankle and/or elbow, wrist, knee, etc 3. Patient with pain at baseline must be >= 30 mm on a 0- 100 mm Visual Analogue Scale. 4. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening. 5. Patients willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1 Patients with known history of intolerance, hypersensitivity or any other contraindication to study drug 2 Patients with clinical laboratory evaluations (including clinical chemistry, haematology and complete urinalysis) are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator 3 Patients treated with other analgesic (NSAIDS, Opioids & Corticosteroids) medications within 1 week prior to the study 4 Patients with chronic and degenerative conditions of pain 5 Pregnant or lactating women 6 Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device) 7 Patients with the history of significant cardiovascular disorders, central nervous system disorders, endocrine disorder, hepatic impairment, renal impairment and other severe condition like asthma, uncontrolled hypertension, collagen disorders, severe infection etc. or any other medical illness that may affect patient safety or difficult to evaluate the efficacy of the product 8 Patients with clinically significant impaired renal or hepatic function (SGOT & SGPT more than 2.5 times the ULN) 9 Patients with estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73m2 10 Patients with known case of Type 1 Diabetes and Type 2 Diabetes Mellitus whose diabetes has not been stable and uncontrolled for the previous three months and with HbA1c value greater than 8 percent. 11 Patients with a history of actively bleeding peptic ulceration or gastrointestinal bleeding 12 Non-compliant with the study medication or any study related procedures 13 Patients who have participated in any clinical trial in the past 3 month 14. Patients who are known seropositive cases of HIV, Hepatitis B or Hepatitis C. 15 Patients with known case of gout pseudogout inflammatory arthritis Paget s disease of bone chronic pain syndrome fibromyalgia or another major joint disease 16 Patients who have a recent history or who are currently known to abuse alcohol or drugs. 17 History of malignancy in last 5 years 18 Any other condition that in the opinion of the Investigator that does not justify the patient participation in the study 16 Patients who have a recent history or who are currently known to abuse alcohol or drugs. 17 History of malignancy in last 5 years 18 Any other condition that in the opinion of the Investigator that does not justify the patient participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients reporting incidences of AE and/or SAE during the study and their assessment in respect to intensity, duration, pattern and causal relationship to the study medication.Timepoint: At Baseline, Day 1, Day 3 and Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Improvement in Visual Analogue Scale (VAS) from baseline to end of the study. â?¢ Improvement in blood inflammatory marker (CRP) from baseline to end of the study. â?¢ Improvement in Subjects Global Assessment (SGA) and Physicians Global Assessment (PGA) from baseline to end of the study. â?¢ Changes in Laboratory Safety Parameters (Haematology, Serum Biochemistry and Urine analysis) from baseline to end of the study. â?¢ Changes in Vital Signs from baseline to end of the study.Timepoint: At Baseline, Day 1, Day 3 and Day 7 From baseline to end of the study. From baseline to end of the study. From baseline to end of the study. From baseline to end of the study. | — |
Countries
India
Contacts
Public ContactDr R M Chhabra
Insignia Clinical Services Pvt. Ltd.
Outcome results
None listed