“An Open Label, Prospective, Non-comparative, Multicentric, Phase IV Clinical Study to Evaluate the Safety, Tolerability and Efficacy of FDC of Trypsin – Chymotrypsin 50000 AU plus Aceclofenac 100 mg plus Paracetamol 325 mg Tablets in Patients for the treatment of acute inflammation and traumatic tissue pain.â€
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Synokem Pharmaceuticals Ltd
- Enrollment
- 200
- Locations
- 4
- Primary Endpoint
- 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.
Study Overview
Brief Summary
Thistrial is an open label, prospective, non-comparative, multicentric, phase IVclinical study to evaluate the safety, tolerability and efficacy of FDC ofTrypsin - Chymotrypsin 50000 AU + Aceclofenac 100 mg + Paracetamol 325 mgTablets in patients for the treatment of acute inflammation and traumatictissue pain.
Patientswho are willing and able to participate in the study will sign and date theInformed Consent Form on the day of screening or baseline visit / Enrollmentvisit (Visit 1). During this screening period, patients who are willing to giveconsent will be evaluated for all the eligibility criteria. Eligible patients withacute painful traumatic condition of orthopaedics such as ankle sprain and whoare aged 18 to 65 years of age (both inclusive) will be considered for thestudy.
After confirming theinclusion/exclusion criteria the subject will be enrolled and provided with studymedication at enrollment visit. Patients will be provided with patient diary atenrollment visit, which need to be brought along with in each subsequent visittill the last visit. Follow up visits will be done on day 3±1, day 7±1 and day10±1 (Final Visit) of treatment to assess safety, tolerability and efficacy.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male or female patients aged between 18 to 65 years (both inclusive).
- •Patients with acute painful traumatic condition of orthopaedics such as ankle sprain.
- •Patients with pain at baseline must be ≥ 30 mm on a 0- 100 mm Visual Analogue Scale.
- •Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •Patients willing to comply with the protocol requirements.
Exclusion Criteria
- •Patients with known history of intolerance, hypersensitivity or any other contraindication to study drug.
- •Patients with clinical laboratory evaluations are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator.
- •Patients treated with Opioids & Corticosteroids within 1 week prior to the study.
- •Patients with chronic and degenerative conditions of pain.
- •Pregnant or lactating women.
- •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).
- •Patients with the history of significant cardiovascular disorders, central nervous system disorders, endocrine disorder and other severe condition like asthma, uncontrolled hypertension and collagen disorders that may affect patient safety or difficult to evaluate the efficacy of the product.
- •Patients with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m
- •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%.
- •Patients with a history of actively bleeding peptic ulceration or gastrointestinal bleeding.
- •Patients who have participated in any clinical trial in the past 3 months.
- •Patients who are known seropositive cases of HIV, Hepatitis B or Hepatitis C.
Outcomes
Primary Outcomes
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.
Time Frame: At Day 3, Day 7 and Day 10
Secondary Outcomes
- Changes in the ankle swelling & redness from baseline to end of the study.(At Visit 1 / Day 1,)
- Changes in Laboratory Parameters (Hematology, Serum Biochemistry and Urine analysis) from baseline to end of the study.(At Visit 1 / Day 1 and)
- Improvement in Visual Analog Scale (VAS) from baseline to end of the study.(At Visit 1 / Day 1,)
- Improvement in Subjects Global Assessment (SGA) and Physicians Global Assessment (PGA) at the end of the study.(At Visit 4 / Day 10)
- Changes in the inflammatory markers (C-reactive protein) from baseline to end of the study.(At Visit 1 / Day 1 and)
- Changes in Vital Signs from baseline to end of the study.(At Visit 1 / Day 1,)