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CTRI Number  CTRI/2015/01/005361 [Registered on: 06/01/2015] Trial Registered Prospectively
Last Modified On: 21/05/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Efficacy, Safety and Tolerability of Fixed Dose Combination of Cephalexin Extended Release (375 mg) and Clavulanate Potassium (125 mg) Tablets with Cephalexin Extended Release (375 mg) Tablets in the Treatment of Uncomplicated Skin and Soft Tissue Infection 
Scientific Title of Study   Comparative Efficacy, Safety and Tolerability of Fixed Dose Combination of Cephalexin Extended Release (375 mg) and Clavulanate Potassium (125 mg) Tablets with Cephalexin Extended Release (375 mg) Tablets in the Treatment of Uncomplicated Skin and Soft Tissue Infection 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
R2013007, version 1 dated 03.02.2014  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Monika Obrah 
Designation  Project Leader 
Affiliation  Sun Pharmaceutical Industries Ltd 
Address  77-B, Sector-18, IFFCO Road, Udyog Vihar Industrial Area Gurgaon – Haryana

Gurgaon
HARYANA
122015
India 
Phone  01244194115  
Fax  01244107000  
Email  monika.obrah@sunpharma.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Upasana Pal 
Designation  Medical Monitor 
Affiliation  Sun Pharmaceutical Industries Ltd 
Address  77-B, Sector-18, IFFCO Road, Udyog Vihar Industrial Area Gurgaon – Haryana

Gurgaon
HARYANA
122012
India 
Phone  01244194217  
Fax  01244107000  
Email  dr.upasana.pal@rsunpharma.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Upasana Pal 
Designation  Medical Monitor 
Affiliation  Sun Pharmaceutical Industries Ltd 
Address  77-B, Sector-18, IFFCO Road, Udyog Vihar Industrial Area Gurgaon – Haryana

Gurgaon
HARYANA
122012
India 
Phone  01244194217  
Fax  01244107000  
Email  dr.upasana.pal@sunpharma.com  
 
Source of Monetary or Material Support
Modification(s)  
Sun Pharmaceutical Industries Ltd. 
 
Primary Sponsor
Modification(s)  
Name  Sun Pharmaceutical Industires Ltd 
Address  MACR, Ranbaxy Research Laboratories, Ltd, Plot No.77-B, Sector-18, IFFCO Road, Gurgaon, Haryana  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 17  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Snehal Sachin Patil  Aster Aadhar Hospital  R.S. No. 628 ‘B’ Ward, Near Shastri Nagar, KMT Workshop, Kolhapur
Kolhapur
MAHARASHTRA 		 0231-6622555

drsnehal.aacr@gmail.com 
Dr Kamlesh K Khandelwal  Bhatia Hospital Medical Research Society  Tardeo Road, Grant Road (W) Mumbai
Mumbai
MAHARASHTRA 		 022-66660630

agrawal.sgarima@gmail.com 
Dr Montu Deka  Down Town Hospital, G S Road,   Down Town Hospital, G S Road, Guwahati – 781006
Kamrup
ASSAM 		 91-9435033901
0361-233067
drmontu_deka@yahoo.com 
Dr M Ramulu   Gandhi Hospital Musheerabad  Department of General Surgery 6th Floor, Gandhi Hospital Musheerabad Secunderabad 500003 Andhra Pradesh
Hyderabad
ANDHRA PRADESH 		 91-8942-279033

r_manchikatla@rediffmail.com 
Dr Abhishek De  Institute of Post-Graduate Medical Education and Research (IPGMER)  Dept of Dermatology Institute of Post-Graduate Medical Education and Research (IPGMER) SSKM Hospital 224, Acharya Jagadish Chandra Bose Road, Kolkata
Kolkata
WEST BENGAL 		 9903275551

dr_abhishek_de@yahoo.co.in 
Dr Guru Prasad  King George Hospital  Department of Dermatology King George Hospital Mahartanipeta Visakhapatnam
Visakhapatnam
ANDHRA PRADESH 		 9848022615

gppatnala@yahoo.co.in 
Dr Shiva Kumar Patil  Kle Society’s Hospital And Medical Research Centre  Dept Of Dermatology Kle Society’s Hospital And Medical Research Centre, Nehru Nagar Belgaum
Belgaum
KARNATAKA 		 9844512315

shivakumarkpatil@gmail.com 
Dr Arun Agarwal  Marwari Hospital & Research Centre, SJ Road, Athgaon,  Marwari Hospital & Research Centre, SJ Road, Athgaon, Guwahati – 781008
Kamrup
ASSAM 		 09864058133

arunaga@hotmail.com 
Dr Yogesh S Marfatia  Medical College & SSG Hospital  Department of Skin and VD, OPD # 1, Medical College & SSG Hospital, Vadodara
Vadodara
GUJARAT 		 9825917442
2652421056
ym11256@yahoo.com 
Dr Rajeev Agarwal  MV Hospital and Research Center  314/30, Mirza Mandi, Chowk, Lucknow
Lucknow
UTTAR PRADESH 		 9838587895
0522-4016051
drrajeeva1@rediffmail.com 
Dr Dipak Umrigar  New Civil Hospital and Govt Medical College Surat  OPD No 1 New Civil Hospital and Govt Medical College Surat Majura Gate Surat
Surat
GUJARAT 		 09925785758

polyumrigar@yahoo.com 
Dr Siddhartha Sankar Das  Peerless Hospital and Research Center Limited  Peerless Hospitex Hospital and Research Center Limited, 360, Panchasayar, Kolkata
Kolkata
WEST BENGAL 		 33-24622394
33-24620692
siddharthadasin@yahoo.co.in 
Dr Rejinold D Lam  Prime Hospital  Plot # 4, Mytrivihar Building, Mytrivanam Back Side, Hyderabad
Hyderabad
ANDHRA PRADESH 		 9618620712

reginold.lam@gmail.com 
Dr VVV Satyanarayana  Rajiv Gandhi Institute of Medical Sciences & RIMS Govt General Hospital  Dept of Dermatology, Rajiv Gandhi Institute of Medical Sciences & RIMS Govt General Hospital, Srikakulam 532001 Andhra Pradesh
Hyderabad
ANDHRA PRADESH 		 9963744345

rimsresearch@gmail.com 
Dr Rajesh Dutt Mehta  S P Medical College & AG of Hospitals  Department of Skin and VD S P Medical College & AG of Hospitals Bikaner 334003 Rajasthan
Bikaner
RAJASTHAN 		 151-2226300

mehtarddr@yahoo.co.in 
Dr Shyamal Balki  Shree Hospital & Critical Care Centre   Om Nagar Opp. Tajshree Building, Sakkardara Square, Nagpur
Nagpur
MAHARASHTRA 		 0712-2705904

kushwahasanjay20@gmail.com 
Dr Suneel Chandrakant Vartak  Sujata Birla Hospital and Medical Research center  Consultant Dermatologist Sujata Birla Hospital and Medical Research center Opposite Bytco College Nashik Road Nashik
Nashik
MAHARASHTRA 		 9373901829
253-2461324
suneel.vartak@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 16  
Name of Committee  Approval Status 
Aster Adhar Ethics Committee  Approved 
Ethics Committee Down Town Hospital  Approved 
Ethics Committee Marwari Hospital  Approved 
Ethics Committee S.P. Medical College and AG of Hospitals, HRM Cardiovasuclar Science and Research  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee on Human Research Medical College Baroda  Approved 
Institutional Ethics Committee, Gandhi Medical College  Approved 
IPGME&R Research Oversight Committee  Approved 
medical research society ethics committee  Approved 
Peerless Hospitex Hospital and Research Center Ltd  Approved 
Shree Hospital Ethics Committee  Approved 
Yash Society Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Uncomplicated Skin and Soft Tissue Infections,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cephalexin Extended Release (375 mg)  Treatment with 1 tablet twice daily for 10 days 
Intervention  Fixed Dose combination of Cephalexin Extended Release (375 mg) and Clavulante Potassium (125 mg)  Treatment with 1 tablet twice daily for 10 days 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Subjects of either sex, aged 12 to 75 years (both inclusive) who have given written informed consent/assent including audio visual recording of consent procedure to participate in the study. An additional written informed consent will be obtained from parent/legally acceptable representative (as applicable) in case assent is taken from subjects aged <18 years.
2. Subjects with diagnosis of uncomplicated skin and soft tissue infections (uSSTI) and culturable microbiological specimen, with an onset of infection ≤ 7 days requiring antibiotic therapy. Acceptable clinical diagnoses of uSSTIs include: simple abscess, impetigo, furunculosis, carbuncles, cellulitis (area <10 cm2), erysipelas, folliculitis, paronychia, superficial wound infections (traumatic, post-surgical) etc.
Note: Microbiological specimens shall be obtained by aspiration of anabscess or swabbing of a draining lesion, prior to the initiation of therapy.
3. Subjects with at least three or more of the following local signs and symptoms of uSSTI accompanied with or without systemic features of infection such as pain/tenderness, purulent drainage/discharge, erythema with or without induration, swelling, fluctuance, heat/localized warmth, regional lymph node swelling or tenderness and/or extension of redness.

Note:
Microbiological specimens (i.e. pus aspirate, swabs from the site of infection) will be collected from all subjects at the time of screening for culture and antibacterial susceptibility testing as per the Hospital/Clinic protocol or practice. Subjects with resistant isolate(s) to study medication or those who are found to be culture negative showing clinical improvement to study drug will be allowed to continue in the study at the discretion of the investigator. Subjects with persistence or worsening of signs and symptoms or appearance of new signs and symptoms associated with skin lesions after at least six doses of treatment will be withdrawn from the study and considered as treatment failures. Their further treatment will be at the discretion of the investigator. The investigator may withdraw a subject at any time during the course of the study if the same is in the best interest of the subject.
Acceptable causative pathogens for uSSTI include: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Klebsiella pneumoniae, Proteus mirabilis, Escherichia coli, Moraxella (Branhamella) catarrhalis and Haemophilus influenzae 
 
ExclusionCriteria 
Details  1. Subjects with history of hypersensitivity to cephalexin, other cephalosporins, penicillins or other beta-lactam class of antibiotics, clavulanate potassium or any of the excipients of study formulation.
excipients-Microcrystalline cellulose, Sodium starch glycolate, colloidal anhydrous silica, magnesium stearate, hypromellose, hydroxypropyl cellulose, Talc, PEG 400, titanium dioxide, indigo Carmine and colloidal anhydrous silica.
2. Subjects requiring hospitalization or parenteral antibiotic treatment.
3. Subjects with complicated acute bacterial skin and skin structure infections (ABSSSI) as judged by the investigator or with chronic or underlying skin condition at the site of infection (e.g., a secondarily infected atopic dermatitis, eczema, acne vulgaris or burn wounds ) or infections involving prosthetic materials (e.g., catheter tunnel infections, orthopedic instruments).
4. Subjects who have received antibiotic treatment for ≥ 24 hours during the 72 hours period prior to enrollment in the study (unless treatment failure was documented).
5. Subjects with concomitant condition requiring non-study antibacterial therapy.
6. Subjects with involvement of perianal area, facial cellulitis or cellulitisassociated with animal or human bite (except insect bite).
7. Subjects with skin and soft tissue infection with suspected or proven contiguous bone, nail bed or scalp involvement.
8. Subjects on chronic immunosuppressive therapy, including use of high dose corticosteroids (≥40 mg prednisolone daily or equivalent), or history of acquired immunodeficiency syndrome (AIDS).
9. Subjects with a history of clinically significant diseases (such as uncontrolled metabolic disorders, cancer etc.) or disorders (other than the disease in consideration) that in the opinion of the investigator may (i) put the subject at risk because of participation in the study (ii) interfere with the study evaluations or (iii) cause concern regarding subject’s ability to participate in the study.
10. Pregnant or breast feeding women or women of child-bearing potential not using medically acceptable methods of contraception or women with positive urine pregnancy test (UPT) at screening.
11. Subjects unwilling or unable to comply with the study procedures.
12. Subjects who have participated in another investigational study in the previous 3 months prior to enrollment in this study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Clinical Outcome  Test of cure visit (7-14 days after end of treatment) 
 
Secondary Outcome  
Outcome  TimePoints 
Microbiological Outcome  Test of cure visit (7-14 days after end of treatment) 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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 3 
Date of First Enrollment (India)   15/01/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NAP 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This will be a randomized, double-blind, double-dummy, comparative, active-controlled, parallel-group multicentric study of 10 days treatment duration followed by a ’Test of Cure’ visit (7-14 days post therapy) with an objective to compare the efficacy, safety and tolerability of FDC of Cephalexin Extended Release (375 mg) anc Clavulante Potassium (125 mg) Tablets with Cephalexin Extended Release (375 mg) Tablets in the Treatment of Uncomplicated Skin and Soft Tissue Infections.

The study will be conducted at 15-17 centres spread over the different geographical locations of India. Adequate number of subjects will be enrolled in equal proportion to have 148 evaluable subjects.The priamry objective of the study is to compare the efficacy of FDC of Cephalexin Extended Release (375 mg) anc Clavulante Potassium (125 mg) Tablets with Cephalexin Extended Release (375 mg) Tablets with respect to clincial outcome (Clinical Cure, clinical improvement or clnical failure) at ’Test of Cure’ visit (7-14 days post therapy) in patients aged 12 to 75 years (both inclusive) with uncomplicated skin and soft tissue infections. The secondary objective of the study are to compare the safety and tolerability of FDC of Cephalexin Extended Release (375 mg) anc Clavulante Potassium (125 mg) Tablets with Cephalexin Extended Release (375 mg) Tablets in the Treatment of Uncomplicated Skin and Soft Tissue Infections.

 

 
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