A randomized, open labeled, observational study to evaluate the intensity and duration of pain at the injection site and safety upon intramuscular administration of Diclotal AQÂ® [Diclofenac sodium 75 mg/mL solution for injection (manufactured by Akums Drugs and Pharmaceuticals Ltd., India)] and Dynapar AQÂ® [Diclofenac sodium 75 mg/mL solution for injection (manufactured by Troikaa Pharmaceuticals Ltd., India)] in patients with arthritisâ??

Akums Drugs and Pharmaceuticals0 个研究点目标入组 12 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1 Patients already diagnosed with arthritis (Rheumatoid arthritis or Osteoarthritis), at least 6 months before to screening.
•2 Patients (male and female) having arthritis pain with VAS score up to 7 (mild to moderate pain).
•3 Patients with Health Assessment Questionnaire Disability Index (HAQ-DI) score between 0-2 for each question.
•4 Patients who are able to and willing to provide written informed consent.
•5 Cooperative and understanding skills.
•6 Patients willing and assessed to be able to participate in all aspects of the core study, including administration of intramuscular injection in the gluteal region, completion of evaluations, and compliance with protocol requirements.

•1 Hypersensitivity to the drugs components or other drug from same class.
•2 Patient unable to refrain from alcohol, psychoactive drugs, and sedatives including sleeping preparations (e.g. benzodiazepines) for the duration of their participation in the study
•3 Patient with history of drug of abuse.
•4 Patients at risk for respiratory depression, patients with increased intracranial pressure or head injury, suffering from severe headache
•5 Patients recently faced any viral or bacterial infection.
•6 Patients have received any biological disease modifying anti rheumatic drugs (eg. Methotrexate, Cyclosporine etc.)
•7 Any psychiatric diseases (including major depression), epilepsy, blood disorders like porphyria.
•8 Patients under treatment for chronic allergy.
•9 Clinical evidence of immunosuppression.
•10 Having participated in other clinical trial less than one year prior to screening.

发起方

Akums Drugs and Pharmaceuticals