Clinical Trial Details (PDF Generation Date :- Tue, 15 Jan 2019 01:50:48 GMT) CTRI Number Last Modified On 27/08/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/09/002004 [Registered on: 14/09/2011] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Multiple Arm Trial To Study Safety and Efficacy of GRANEXIN GEL plus Standard of Care as compared to standard of Care alone in reducing scar formation in wounds following laparoscopic surgery A Phase II, Prospective, Randomized, Double blind, Within-Subject Control, Multi-Center Study to Determine the Safety and Efficacy of GRANEXIN GEL in Reducing Scar Formation in Surgical Incisional Wounds following Laparoscopic Surgery Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) 2011-LSS-001 Designation Affiliation Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Email Designation Affiliation Details Contact Person (Scientific Query) Dr Atul Gupta Medical Monitor Max Neeman International Phone 91-9717287654 Fax 91-11-41001945 Email Designation Affiliation Max Neeman International Ltd. MaX House, 1st Floor 1, Dr Jha Marg, Okhla - III New Delhi - 110 020 South DELHI 110 020 Atul.Gupta@neemanasia.com Details Contact Person (Public Query) Dr Jayashri Krishnan Associate Director-Monitoring Phone 91-9952910703 Max Neeman Medical International,No. 11 A,TNGO Colony, I Street, Nanganallur Chennai TAMIL NADU 600061 page 1 / 6
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax Email Jayashri.Krishnan@neemanasia.com Source of Monetary or Material Support > FirstString Research, Inc. 475-A East Bay Steet Charleston, SC 29403 Primary Sponsor Details FirstString Research Inc 475-A East Bay Steet Charleston, SC 29403 Type of Sponsor NIL List of Countries of Principal Investigator Pharmaceutical industry-global NIL of Site Site Phone/Fax/Email Dr Meenakshi Sharma Paras Hospitals Paras Hospitals, Department of General and Laproscopic surgery, Room No.37, Ground Floor C-1 Block,Sushant Lok, Phase-I,Sec-43, Gurgaon, Haryana-122002 Gurgaon HARYANA Dr G Venkat Rao DrNirmal Chopra Dr J S Rajkumar Asian Institute of Gastroenterology Dr.Chopra Super Specality Hospital Life Line Mutispeciality Hospital Asian Institute of Gastroenterology, Department of Gastroenterlogy and Minimal Invasive surgery 6-3-661,Somajiguda, Hyderabad. Hyderabad ANDHRA PRADESH Surgeon Gynecologist Dr.Chopra Super Specality Hospital,Gurdhuwar Road,Sadar Bazar,Agra-UP Agra UTTAR PRADESH Life Line Mutispeciality Hospital, Department of Surgical Gastro Enterelogy, Ground Floor, No 5/639, Rajiv Gandhi Salai (OMR) Perungudi, Chennai 600 096. Chennai 600 096 Chennai TAMIL NADU 91-9810794347 91-124-4585572 doctor_sharma@hotmai l.com 91-40-23378888 91-40-23324255 drraogv@sify.com 91-9359488842 drgmprasad@gmail.co m 91-9840599666 91-44-42803004 rjkmr_js@yahoo.co.in Dr Jayashree Poona Hospital & Poona Hospital & 91-9823090505 page 2 / 6
Details of Ethics Committee Shankarrao Todkar Research Centre Research Centre, Deaprtment of Laproscopic Surgery and Bariatric Surgery 27 Sadshiv Peth,Pune 411030 Pune MAHARASHTRA Dr Prashant Vithalrao Rahate Dr A Ravi Rahte Surgical Hospital & ICU Sri RamaChandra Medical Center Rahte Surgical Hospital & ICU, Department of General Laproscopic Surgery 517,Kolba swami square Old mangalwari, central avenue Nagpur 440008, Maharastra, Nagpur MAHARASHTRA Sri RamaChandra Medical Center, D2 Secod Floor, Department of Gastro Enterology, Chennai-600116,Tamil Nadu Chennai TAMIL NADU 91-20-24338477 jayatodkar@hotmail.co m 91-9822464068 91-712-6536080 prashantrahate84@yah oo.com 91-44-24768637 91-44-45928678 draravi2k@yahoo.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Committee Asian Institute of Gastroenterology 6-3-661,Somajiguda, Hyderabad Committee Dr.Chopra Super Specality Hospital,Gurdhuwar Road,Sadar Bazar,Agra-UP Approved 05/08/2011 No Approved 08/11/2011 No Committee Life Line Mutispeciality Hospital No 5/639, Rajiv Gandhi Salai (OMR) Perungudi, Chennai 600 096 Approved 12/07/2011 No Committee Paras Hospitals C-1 Block, Sushant Lok, Phase-I, Sec-43, Gurgaon, Haryana-122002 Committee Poona Hospital & Research Centre 27 Sadshiv Peth, Pune 411030 Approved 14/05/2011 No Approved 03/06/2011 No page 3 / 6
Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Committee Rahte Surgical Hospital & ICU 517, Kolba Swami square, Central Avenue, Nagpur -08 Committee Sri RamaChandra Medical Cente Chennai-600116,Tamil Nadu, Status Approved 29/04/2011 Yes Approved 08/08/2011 No Date Approved/Obtained 29/08/2011 Health Type Patients Condition Scar Formation in Surgical Incisional Wounds following Laparoscopic Surgery Type Details Intervention GRANEXIN GEL Study treatment incisional site: GRANEXIN GEL is a low molecular weight gap junction (ACT-1) peptide formulated in 1.25% Hydroxyethylcellulose gel for topical applications for the management of wounds. 100?M concentration of GRANEXIN GEL will be applied at Day 1 and Day 2 along with standard of care achieved with Tegaderm. GRANEXIN GEL will be applied over the muscle before suturing and over the incision site after suturing. Incision will be covered completely with occlusive dressing after suturing. Comparator Agent Age From Age To Gender Details Control Incisional site: Standard of Care would be occlusive dressing achieved with Tegaderm 18.00 Year(s) 99.00 Year(s) Both Inclusion Criteria 1. Male or female aged 18 years and older. Control Incisional site: Standard of Care would be occlusive dressing achieved with Tegaderm 2a. Female subjects must be post-menopausal or surgically sterilized. or 2b. Female subjects of childbearing potential must have negative pregnancy test at screening, and agrees to use hormonal contraceptive or intra-uterine device or diaphragm with spermicide or condom with spermicide or abstinence throughout the study. 3. Subjects undergoing Laparoscopic procedures with at least two 10 mm long full-thickness surgical incisions. page 4 / 6
4. Signed informed consent form. Exclusion Criteria Exclusion Criteria Details 1. Subjects with a history of skin irritation or infection in the past 6 months in the intended area of incision.2. Subjects with a history of keloids.3. Known conditions of collagen vascular diseases.4. Subjects with clinically significant medical conditions as determined by the Investigator, which would impair wound healing including renal, hepatic, hematologic, neurologic or immune disease. Examples include but are not limited to: a. Renal insufficiency as an estimated GFR, which is 30 ml/min/1.7m2. b. Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range. c. Hepatic insufficiency defined as total bilirubin 2 mg/dl or serum albumin 25 g/l. d. HbA1c 9.0%. e. Hemoglobin 10 g/dl in males and 9 g/dl in females. f. Hematocrit 0.30. g. Platelet count 100,000. 5. Presence of an active systemic or local cancer or tumor of any kind (with the exception of nonmelanoma skin cancer).6. Current treatment with systemic corticosteroids (15 mg/day), or immunosuppressive agents.7. Previous or current radiation therapy or likelihood to receive this therapy during study participation.8. Pregnant or nursing subjects.9. Known prior inability or unavailability to complete required study visits during study participation.10. A psychiatric condition (e.g., suicidal ideation) or chronic alcohol or drug abuse problem, determined from the subjects medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance.11. Use of any investigational drug or therapy within the 28 days prior to screening.12. Any other factor, which may, in the opinion of the Investigator, compromise participation and follow-up in this study. Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized Participant and Investigator Blinded Primary Outcome Outcome Timepoints Reduction in scarring as assessed using the Vancouver Scar Scoring Scale from week 2 to end of study at month 9 Secondary Outcome Outcome Timepoints Target Sample Size Reduction in scarring using the Patient and Observer Scar Assessment Scale. Reduction in scarring as assessed using the Vancouver Scar Scoring Scale. Investigators wound assessment using the Global Assessment scale Investigators assessment of healing rate and incidence of infections. Incidence of treatment related adverse events. Total Sample Size=92 Sample Size from =92 from week 2 to month 1, 3, 6 and 9 from week 2 to month 1, 3 and 6 from baseline to week 2, month 1, month 3, month 6 and month 9 from day 3 till study exit through out the study. page 5 / 6
Powered by TCPDF (www.tcpdf.org) PDF of Trial Phase of Trial Phase 2 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 08/10/2011 No Date Specified Years=1 Months=0 Days=0 Not Applicable Completed none as yet This Phase II, prospective study is designed as a multicenter, double blind, within-subject control study in which subjects undergoing laparoscopic surgery will be randomly allocated to receive concentration GRANEXIN GEL plus Standard of Care (SoC) as compared to Standard of Care alone following the surgery. 100?M concentration of GRANEXIN GEL will be applied at Day 1 and Day 2 along with standard of care. The outcome of this study would be Reduction in scarring from week 2 to end of study at month 9 as assessed using the Vancouver Scar Scoring Scale, Patient and Observer Scar Assessment Scale, Investigator s wound assessment using the Global Assessment scale from baseline to week 2, month 1, month 3, month 6 and month 9 and Investigator s wound assessment using the Global Assessment scale from baseline to week 2, month 1, month 3, month 6 and month 9. page 6 / 6