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临床试验/CTRI/2020/12/029771
CTRI/2020/12/029771已完成1 期

An open label, multicenter, randomized, parallel, single-dose, comparative bioavailability study of Triamcinolone Hexacetonide Injectable Suspension USP 20 mg/ml of Abbott Healthcare Private Limited, India (Test) and Triamcinolone Hexacetonide 20 mg/ml suspension for injection of Intrapharm Laboratories Ltd, UK (Reference) in patients with knee osteoarthritis. - THA BA study

Abbott Healthcare Pvt Ltd0 个研究点目标入组 44 人开始时间: 待定最近更新:
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试验速览

阶段
1 期
状态
已完成
入组人数
44
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Ba/be

入排标准

入选标准

  • •1. Participant must sign an ICF to participate in the study indicating that he / she understands the purpose of, and procedures required for the study as described in this protocol and is willing to and will be able to adhere to requirement of the protocol.
  • •2. Participant must be >=40 years of age inclusive, at the time of signing the informed consent.
  • •3. Participants having Body mass index (BMI) <=40 Kg/m2.
  • •4. Symptoms associated with OA of the knee for >=6 months prior to Screening (patient reported is acceptable).
  • •5. The Participant has documented radiographic evidence of OA of grade 3 only according to Kellgren-Lawrence criteria(1), using radiographs performed within 03 months of screening date.
  • •6. Patients with knee OA requiring intraarticular corticosteroids in a dose of 20 mg/ ml for acute management of symptoms as per investigators.
  • •7. Index knee pain for >15 days over the last month (as reported by the patient).
  • •8. If bilateral OA existed, pain in the contralateral knee was less than pain in the index knee, as reported by the patient.
  • •9. Investigator confirms that participant will not require, and participant confirm willingness to abstain from use of the following protocol-restricted medications during the study:
  • •a. Intravenous (IV), Intramuscular (IM), oral, inhaled, intranasal or topical corticosteroids
  • •b. IA corticosteroids in any joint
  • •c. IA viscosupplementation (hyaluronic acid) in index knee
  • •d. Any investigational drug or device
  • •e. Immunomodulators, immunosuppressives, or chemotherapeutic agents
  • •f. Live or live attenuated vaccines
  • •10. Participants must be ambulatory and must be medically/clinically stable on the basis of physical examination, medical history, vital signs, chest x ray PA view, 12 lead ECG and clinical laboratory parameters performed at screening visit. Any abnormalities or deviation from normal, must be consistent with the underlying illness in the study population and judged by investigator to be not clinically significant. This determination must be recorded in the participants source documents and initialed by the investigator.
  • •11. A woman of childbearing potential must have a negative highly sensitive serum (Beta-human chorionic gonadotropin [Beta-hCG]) at screening
  • •12. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
  • •a. Is not a woman of childbearing potential (WOCBP)
  • •b. Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency when used consistently and correctly, as described in Section 9.7 during the study period and for a period of at least 90 days after the EOS visit and agrees not to donate eggs (ova, oocytes) for thepurpose of reproduction during the study and for a period of at least 90 days after the EOS visit. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
  • •c. A WOCBP must have a negative highly sensitive serum pregnancy test within 7 days before the first dose of study intervention.
  • •d. The investigator is responsible for review of medical history, menstrual history, and recent sexual ac

排除标准

  • •1. Any condition that could possibly confound the patientâ??s assessment of index knee pain in judgment of the investigator (i.e., ipsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassification, pain in any other area of the lower extremities or back that is equal to or greater than the index knee pain)
  • •2. Fibromyalgia, Reiterâ??s syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease.
  • •3. History of infection in the index knee.
  • •4. Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening.
  • •5. Unstable joint (such as a torn anterior cruciate ligament) within 12 months of Screening.
  • •6. Uncontrolled diabetes as indicated by a hemoglobin A1c (HbA1c) of > 7.5%.
  • •7. Known hypersensitivity to any form of triamcinolone or its excipients.
  • •8. Intra-articular corticosteroids in any joint within 6 months prior to screening.
  • •9. Intra-articular visco-supplementation (hyaluronic acid) in the index knee within 6 months from screening.
  • •10. Any other investigational drug or device within 6 months from screening.
  • •11. Planned/anticipated surgery of the index knee or any other surgery that would require use of a restricted medication during the study period.
  • •12. Prior arthroscopic or open surgery of the index knee within 12 months of Screening.
  • •13. Any infection requiring intravenous antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening.
  • •14. History of osteomyelitis.
  • •15. Known or clinically suspected infection with human immunodeficiency virus (HIV), hepatitis B or C viruses.
  • •16. Any clinically significant ECG abnormality as judged by the Investigator.
  • •17. Patients requiring or likely to require chronic treatment with corticosteroids during the study period based on patient medical history.

研究者

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