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CTRI Trial Data

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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Tue, 28 Sep 2021 17:27:10 GMT) CTRI Number CTRI/2009/091/000741 [Registered on: 16/09/2009] - Last Modified On Post Graduate Thesis Type of Trial Type of Study Study Design Single Arm Trial Public Title of Study A phase II a clinical trial for a novel molecule (LL 3858) developed by Lupin Limited which has the potential of treating the Pulmonary tuberculosis patients effectively. Scientific Title of A Phase IIa, Open Label Study to Determine the Early Bactericidal,Extended Early Bactericidal Study Activity and Pharmacokinetic Study of LL 3858 of Lupin Limited for the Treatment of Newly Diagnosed Sputum Smear-Positive Pulmonary Tuberculosis. Secondary IDs if Any Secondary ID Identifier LRP/CTP/022/3858/II/01 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr.Nirmal Kumar Jain Trial Coordinator (multi-center study) Designation Affiliation Address Professor and Head,Department of Chest Diseases and TB, SMS Medical College, Superintendent,Hospital for Chest Diseases and TB Jaipur RAJASTHAN 302016 India Phone +911412281001 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr. Rajesh Kumawat Query) Designation Affiliation Address Lupin Limited, Lupin Research Park,46 A/47A, Nande Village, Mulshi Taluka Pune MAHARASHTRA 411042 India Phone +91-20-66749400 Fax +91-20-66749458 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr.Anil Avhad Designation Affiliation Address Lupin Limited (Lupin Research Park) 46A/47A,nande Village,Mulshi Taluka Pune MAHARASHTRA 411042 India page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Phone +91-20-66749424 Fax +91-20-66749560 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Council of Scientific & Industrial Research (CSIR),India,under NMITLI programme > Lupin Limited(Research Park),46A/47A, Nande Village, Mulshi-Taluka,Pune-411042,Maharashtra(India) Primary Sponsor Primary Sponsor Details Name Lupin Limited(Research Park),46A/47A, Nande Village, Mulshi-Taluka,Pune-411042,Maharashtra(India) Address Type of Sponsor Details of Secondary Name Address Sponsor Nil Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr.N K Jain Hospital for Chest Subashnagar,Shastrina +911412281001 Diseases and TB gar,-302016 Jaipur [email protected] RAJASTHAN Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? ETHICS COMMITTEE Approved No Date Specified Not Available (EC) SMS MEDICAL COLLEGE & ATTACHED HOSPITALS,Jaipur Regulatory Clearance Status Date Status from DCGI Approved/Obtained No Date Specified Health Condition / Health Type Condition Problems Studied Newly Diagnosed Sputum Smear Positive Pulmonary Tuberculosis. Intervention / Type Name Details Comparator Agent Intervention Oral Tablets Of LL 3858 400mg of LL 3858 OD for 5 days Comparator Agent Nil Nil Inclusion Criteria Inclusion Criteria Age From Age To Gender Details 1Newly diagnosed, previously untreated patients with pulmonary tuberculosis who have atleast 2 sputum smear positive by fluorescent microscopy. 2 Male patients of 18 to 55 years of age. 3 Body weight of 35-60 kg. 4 Willing to stay in the hospital during the study. 5 Willing to sign Informed Consent. Exclusion Criteria Exclusion Criteria Details 1 Clinical evidence of Tuberculosis of the Central Nervous System or page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in other extra pulmonary forms of tuberculosis (However patients with concomitant lymphnode tuberculosis can be enrolled) 2 Female patients. 3 Concurrent nontuberculous pneumonia. 4 Presence of QTc prolongation (greater than 450 msec) on the baseline ECG 5 Having other serious complicating diseases,for e.g. diabetes mellitus, hypertension, peptic ulcer disease, epilepsy & leprosy. 6 Those unable to produce an adequate volume of sputum (5ml or more in 16 hours). 7 Patients who are too ill to tolerate a seven days delay in standard therapy. 8 Evidence of abnormal hepatic & renal function. -Serum bilirubin > 1.2 mg/dl - AST and ALT are > 2 times the upper limit of normal -AST or ALT is > 4 times the upper limit of normal -Blood urea or serum creatinine above the upper limit of normal (43 and 1.3 mg/dl respectively) 9 Patients with raised Creatinine Phosphokinase levels (>200 U/L). 10 Patients positive for disease markers of Hepatitis B virus, Hepatitis C virus 11 Alcohol or drug dependence/abuse 12 HIV positive Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints To evaluate safety and fall in log10 colony Sputum samples(16 hour collection) will be forming units (CFU) of Mycobacterium collected before 1st, 3rd, 4th dose and on Day 6 tuberculosis per ml sputum per day viz.0-2 days (EBA study) and 2-5 days (Extended EBA) Secondary Outcome Outcome Timepoints To determine the Pharmacokinetic profile of Serial blood samples (2 ml) will be collected at 400mg of LL 3858 predose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours after 1st and 5th dose administration. Blood sample will also be collected on Day 7 (48 hours after last dose) and on Day 8 (72-hours after last dose). Urine Pk 0 to 12 and 12 to 24 hours after first and fifth dose Target Sample Size Total Sample Size=40 Sample Size from India= Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial Phase 2 Date of First No Date Specified Enrollment (India) Date of First 02/12/2009 Enrollment (Global) Estimated Duration of Years=0 Trial Months=6 Days=0 Recruitment Status of Completed Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary This study is a Single Arm open label study and will be conducted at one center to Determine the Early Bactericidal,Extended Early Bactericidal Activity and Pharmacokinetic Study of 400 mg of LL 3858 for the Treatment of Newly Diagnosed Sputum Smear-Positive Pulmonary Tuberculosis. Approximately 40 patients will be enrolled so as to have 20 analyzable patients The patients will be admitted for 7 days. The IP Tablet (400mg of LL 3858) will be administered orally once daily for 5 page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in days on empty stomach. The patients will be shifted to the standard ATT from day 7 onwards. Patients receiving the study drug will be evaluated by sputum examination. The primary outcome measures will be to evaluate safety and fall in log10 colony forming units (CFU) of Mycobacterium tuberculosis per ml sputum per day viz.0-2 days (EBA study) and 2-5 days (Extended EBA) The secondary outcome will be to determine the Pharmacokinetic profile of 400mg of LL 3858. page 4 / 4 Powered by TCPDF (www.tcpdf.org).
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