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1 Clinical Trial Details (PDF Generation Date :- Sun, 17 Mar :11:08 GMT) CTRI Number CTRI/2010/091/ [Registered on: 11/08/2010] - Last Modified On 14/03/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Single Arm Trial A clinical trial to study the effects of FDC of Cephalexin Extended Release and Clavulanate Potassium Tablets in patients with upper respiratory tract infections. "Efficacy, Safety and Tolerability of Fixed Dose Cbination of Cephalexin Extended Release and Clavulanate Potassium Tablets in the Treatment of Upper Respiratory Tract Infections" Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) RCEPCL Designation Affiliation Protocol Number Details of Principal Investigator Amit Nasa Project Leader Phone Fax Designation Affiliation Project Leader, Ranbaxy Laboratories Ltd. Plot No.77-B, Sector-18, IFFCO Road Gurgaon HARYANA amit.nasa@ranbaxy.c Details Contact Person (Scientific Query) Sanjay K Sharma Associate Director Phone Fax Designation Affiliation Medical Monitor, Ranbaxy Laboratories Ltd. Plot No.77-B, Sector-18, IFFCO Road Gurgaon HARYANA ashish.dhabre@ranbaxy.c Details Contact Person (Public Query) Amit Nasa Project Leader Project Leader, Ranbaxy Laboratories Ltd Plot No.77-B, Sector-18, IFFCO Road Gurgaon HARYANA page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax Source of Monetary or Material Support > Ranbaxy Laboratories Ltd., Plot No. 77-B, Sector 18, Gurgaon , Haryana Type of Sponsor Nil List of Countries of Principal Investigator Dr. Anand Patel Primary Sponsor Details MACR,, Ltd, Plot No. 77-B, Sector-18, IFFCO Road, Gurgaon , Haryana Pharmaceutical industry-global Nil of Site Site Phone/Fax/ Anand Multispeciality Hospital Anand Multispeciality Hospital,Sundervan Cplex, B Tower, B/H. I.T.I Vadodara GUJARAT Dr. Akash Lataru Balki Chest Care Hospital Chest Care Hospital,Sakkardhara SQ, Umred Road Nagpur Dr. Mukesh Jain Dr. Mukesh Jain Clinic Dr. Mukesh Jain Clinic,70/70, Madhyam Marg, Mansarovar Jaipur RAJASTHAN Dr. Sonia K Dalal Kalyan Polyclinic Kalyan Polyclinic, , Shree Hari Corner,RC Dutt road, Alkapuri Vadodara GUJARAT Dr. Puneet Rijhwani Mahatma Gandhi Medical College & Hospital Mahatma Gandhi Medical College & Hospital,Sitapura Tonk Road Jaipur RAJASTHAN Dr. Aniket Joshi OM Clinic OM Clinic, 1 Niratinath soc,mukund Nagar Pune Dr. Yogesh Kadam Poona Diabetes Center Office No. 8, 1st Floor, Bharat Arcade,Gen. Thimmaya (0265) anandmultispecialityhos pitals@yahoo.c akash_balki@yahoo.co m drmukesh13@yahoo.co m (0265) drsoniadalal@hotmail.c puneet284@rediffmail.c (020) acj @yahoo.c (020) drprayogk@rediffmail.c page 2 / 6

3 Details of Ethics Cmittee Dr. Sandeep Saboo Dr. Manish Kumar Jain Saboo Hospital and Research Center Shwaas Center, Navkar Hospital Road Pune Saboo Hospital and Research Center, /27, Begum Bazar Hyderabad ANDHRA PRADESH G-11, Shubham Apartment,,Central Spine, Vidhyadharnaga r Jaipur RAJASTHAN Dr. Sunil Singhvi Singhvi Clinic Singhvi Clinic, No.127,Mint Street, Sowcarpet Chennai TAMIL NADU Dr. Vivek Gupta Suretech Hospital and Research Centre Suretech Hospital and Research Centre,R.P. Banerjee Marg, Dhantoli Nagpur ffmail.c , nil ail.c (044) of Cmittee Approval Status Date of Approval Is Independent Ethics Cmittee? Chennai Ethical Cmittee, Chennai (for Dr Sunil Singhvi) Ethics cmittee of Biniwale clinic, Pune (for Dr Aniket Joshi) Ethics cmittee of Biniwale clinic, Pune (for Dr Yogesh Kadam) G. G. Memorial Ethical Cmittee For Human Research, Jaipur Approved 17/11/2010 Yes Approved 31/05/2010 Yes Approved 31/05/2010 Yes Approved 21/04/2010 No Institutional Ethics Cmittee, Mahatama Gandhi Medical College and Hospital, Jaipur Approved 20/09/2010 No Maanav Health Foundation Independent Ethics Cmittee, vadodara (for Dr Anand Patel) Maanav Health Foundation Independent Ethics Cmittee, Vadodara (for Dr Sonia Dalal) Midcity Independent Ethics Cmittee, Nagpur (for Dr Akash Approved 27/05/2010 Yes Approved 27/05/2010 Yes Approved 06/06/2010 Yes page 3 / 6

4 Regulatory Clearance Status fr DCGI Health Condition / Problems Studied Intervention / Cparator Agent Inclusion Criteria Balki) Midcity Independent Ethics Cmittee, Nagpur (for Dr Vivek Gupta) Saboo Hospital & Research Center,Independent Ethics cmittee, Hyderabad (for Dr Sandeep Saboo) Swasthya Kalyan Ethics Cmittee, Jaipur (for Dr Mukesh Jain) Status Approved 06/06/2010 Yes Approved 26/06/2010 Yes Approved 14/04/2010 Yes Date Approved/Obtained 08/04/2010 Health Type Patients Condition Upper Respiratory Tract Infections Type Details Intervention FDC of Cephalexin extended release and clavulanic potassium Cparator Agent nil nil Age Fr Age To Gender Details Year(s) Year(s) Both Inclusion Criteria Cephalexin ER 375mg and clavulanate potassium 125 mg tablets orally, twice daily for 10 days Subjects of either sex aged more then or equal to 12 years and weighing more then or equal to 40 kg suffering fr upper respiratory tract infection (with onset of infection less then 7 days) with diagnosis of acute pharyngitis and/or tonsillitis. Diagnosis will be made on the basis of clinical and microbiological criteria Clinical criteria Clinical diagnosis will be based on following signs and sympts: sore and scratchy throat and/or pain on swallowing along with any two of following: Tonsillar and/or pharyngeal exudates, tonsillar and/or pharyngeal erythema, fever [temp. more then or equal to 38C/ & more then or equal to 100.4F (or history of fever treated with antipyretics)], uvular edema, tender cervical adenopathy. Microbiological criteria A positive pre-treatment throat swab culture defined as identification of at least one of the following respiratory pathogens: Streptococcus pyogenes, Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella (Branhamella) catarrhalis, Staphylococcus aureus. Note: Treatment will be initiated before the results of throat swab culture are available. However,when these results bece available (within 3-5 days of enrollment), suitability of subject for inclusion will be reviewed. Subjects with sterile culture or culture not positive for respiratory pathogens as defined above will be withdrawn fr the study. Subjects showing clinical improvement with isolate (s) resistant to study medication will be allowed to continue at the page 4 / 6

5 Exclusion Criteria Method of Generating Rand Sequence Method of Concealment Blinding/Masking Details discretion of the investigator. Subjects who have persistence or worsening of signs and sympts or appearance of new signs and sympts after 3 days of treatment will be withdrawn fr the study Exclusion Criteria 1.Subjects with history of hypersensitivity to cephalexin, other cephalosporins, penicillins, clavulanate potassium or other betalactam class of antibiotics or any of the excipients* of study formulation 2.Subjects requiring hospitalization or parenteral antibiotic treatment 3.Subjects who have received antibiotic treatment for >/= 24 hours during the 72 hours prior to enrollment in the study (unless treatment failure was documented) 4.Infection of the deep tissues of the upper respiratory tract (e.g. epiglottitis, retropharyngeal or buccal cellulitis or abscess of the retropharynx/ tonsil or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (e.g. sinusitis, otitis media or orbital/periorbital cellulitis) 5.Subjects with a concitant infection that needs an additional anti-microbial agent or which in the opinion of the investigator could preclude evaluation of response to study medication 6.Subjects with renal failure who are on hemodialysis, peritoneal dialysis, plasmapheresis or hemoperfusion 7.Subjects who are unable to take oral medication 8.Subjects with clinically significant cardiovascular, hematological (including subjects with bleeding diathesis, on anticoagulant therapy or with vitamin K deficiency), renal, hepatic, endocrinal, pulmonary, urogenital, gastrointestinal, progressive neurological illness (including subjects with history of epilepsy) or psychiatric illness or any other medical condition that might put the subject at greater risk during study participation 9.Pregnant or breast feeding wen or wen of child-bearing potential not using medically acceptable methods of contraception or wen with positive urine pregnancy test (UPT) at screening 10.Subjects with history of drug or alcohol abuse 11.Subjects unwilling or unable to cply with the study procedures 12.Subjects who have participated in another investigational study in the previous 3 months prior to enrollment in this study 13.Subjects on chronic immunosuppressive therapy or diagnosis of acquired immunodeficiency syndre (AIDS) or hepatitis 14.Subjects with SGOT/AST or SGPT/ALT >3.0 times upper limit of normal (ULN) or alkaline phosphatase >2.0 times ULN or serum bilirubin >1.5 times ULN or TLC <4000/mm3 or creatinine clearance of <30 ml/ min (estimated fr serum creatinine using the Cockcroft-Gault formula**) *Microcrystalline cellulose; sodium starch glycolate; colloidal Anhydrous silica; magnesium stearate; hyprellose; hydroxypropyl cellulose; talc; opadry; polyethylene glycol **Creatinine clearance (CLcr) = 140? age (years) x weight (kg) 72 x serum creatinine (mg/dl) For female subjects: Final value as per above formula should be multiplied by 0.85 Primary Outce Outce Timepoints Investigator assessed clinical outce in clinically evaluable subjects At test-of-cure visit (4-8 days after end of treatment) Secondary Outce Outce Timepoints Microbiological outce in all microbiologically evaluable subjects At test-of-cure visit (4-8 days after end of treatment) page 5 / 6

6 Powered by TCPDF ( Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=100 Sample Size fr =100 27/01/2011 No Date Specified Years=0 Months=6 Days=0 Cpleted This study is an open-label, non-cparative study with an objective to cpare the Efficacy, Safety and Tolerability of Fixed Dose Cbination of Cephalexin Extended Release and Clavulanate Potassium Tablets in the Treatment of Upper Respiratory Tract Infections. The study is to be conducted at 10 centres all over. The primary outce is Investigator assessed clinical outce in clinically evaluable subjects at test-of-cure visit (4-8 days after end of treatment) and secondary outce is Microbiological outce in all microbiologically evaluable subjects at test-of-cure visit (4-8 days after end of treatment). page 6 / 6