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CTRI Number  CTRI/2009/091/000492 [Registered on: 29/07/2009]
Last Modified On: 22/02/2013
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study
Modification(s)  		  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study
Modification(s)  		 A Clinical trial study to evaluate the blood concentration and safety of single and multiple Diclofenac Sodium topical patches following single-day and multiple-day application  
Scientific Title of Study
Modification(s)  		 A Randomized Study Evaluating the Systemic Pharmacokinetics and Safety of Single and Multiple Diclofenac Sodium Topical Patches Following Single-day and Multiple-day Application  
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
DCF-007  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Anil K 
Designation   
Affiliation   
Address  Clinigene House, Tower I, Semicon Park, Electronic City, Phase II, Hosur Road, Bangalore

Bangalore
KARNATAKA
560 100
India 
Phone  08028082771  
Fax  08028082722  
Email  Anil.Dr@clinigeneintl.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Shrinivas Savale 
Designation   
Affiliation   
Address  Clinigene International Limited, Tower I, Semicon Park, Electronic City, Phase II, Hosur Road, Bangalore

Bangalore
KARNATAKA
560 100
India 
Phone  08028082739  
Fax  08028082722  
Email  Shrinivas.Savale@clinigeneintl.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Siddangouda Patil 
Designation   
Affiliation   
Address  Clinigene International Limited, Clinigene House,Tower I, Semicon Park, Electronic City, Phase II, Hosur Road, Bangalore

Bangalore
KARNATAKA
560 100
India 
Phone  08028082818  
Fax  08028082722  
Email  Siddangouda.patil@clinigeneintl.com  
 
Source of Monetary or Material Support
Modification(s)  
Cerimon Pharmaceuticals, Inc. 
 
Primary Sponsor
Modification(s)  
Name  Cerimon Pharmaceuticals Inc 
Address  Cerimon Pharmaceuticals, Inc. 701 Gateway Boulevard, Suite 100, South San Francisco CA 94080 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
Nil   
 
Countries of Recruitment
Modification(s)  		   India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anil K  Human Pharmacology Unit, Clinigene International Limited  Clinigene House, Tower I, Semicon Park,,Electronic City, Phase II, Hosur Road,Bangalore-560100
Bangalore
KARNATAKA 		 08028082771
08028082722
Anil.Dr@clinigeneintl.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
I.E.C. Consultants  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Study will be conducted in Healthy male/female volunteers 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Diclofenac sodium patches  15 mg using one 7x10 cm 15 mg patch 30 mg using two 7x10 cm 15 mg patch 60 mg using four 7x10 cm 15 mg patch 30 mg using one 10x14 cm 30 mg patch 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Healthy male or female volunteers aged 18 - 75 years

2. Provide written informed consent to
participate in all aspects of the study

3. Have a negative urine pregnancy test result, prior to study entry, for all female subjects of childbearing potential

4. Use an effective birth control method and a willingness to continue birth control during the study and for 2 weeks following the study, for female subjects of childbearing potential
 
 
ExclusionCriteria 
Details  1. A history of intolerance or hypersensitivity to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) 2. A history of hypersensitivity to Diclofenac or Diclofenac-containing products 3. A history of asthma within 1 year of study entry 4. A history of peptic ulcer within 1 year of study entry, any history of gastrointestinal bleeding or coagulation disorder (with the exception of bleeding due to internal or external hemorrhoids) 5. Current smoker or history of smoking within 6 months of study entry 6. Clinically significant active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular disease 7. Clinically significant abnormal clinical laboratory test results during screening period 8. Positive test result for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV) 9. Allergy to adhesives (e.g. adhesive tape) 10. Topical lotions, creams or gels applied to the application site within 7 days prior to randomization 11. Active skin disease involving the back (general area where patch(es) will be applied) 12. Excessive hair, abrasion, irritation, bruising, scarring or other damage to the skin of the back area 13. Any medications including prescription, over-the-counter and herbal products within 30 days prior to dosing. If any medication has been used infrequently during this window, the sponsor will be contacted to determine eligibility. 14. Positive urine drug screen for any drug of abuse (including but not limited to amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines) 15. Positive alcohol breath test. Subjects will be instructed to refrain from alcohol use for at least 48 hours prior to screening, and during confinement/dosing period and follow-up period. 16. Treatment with an investigational drug or device within 30 days before study entry 17. Treatment with an investigational biologic within 6 months before study entry 18. Blood donation within 30 days of enrollment 19. Any ECG abnormalities unless approved by the Medical Monitor 20. Pregnant or breast-feeding females  
 
Method of Generating Random Sequence
Modification(s)  		 Permuted block randomization, variable 
Method of Concealment
Modification(s)  		 Centralized 
Blinding/Masking
Modification(s)  		 Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Safety: To assess and compare the systemic and topical safety and tolerability of the topical patch formulation application.  4 days 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size
Modification(s)  		 Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial
Modification(s)  		 Phase 1 
Date of First Enrollment (India)
Modification(s)  		 07/09/2009 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  		 Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 Primary Objectives Pharmacokinetics: (1) to assess the pharmacokinetics of a diclofenac sodium topical patch with a once daily application of either one, two or four diclofenac sodium 7x10 cm, (15 mg) topical patches (total of 15, 30 or 60 mg of the sodium salt) as well as one 10x14 cm (30 mg) of the sodium salt for 4 consecutive days. Safety: to assess the systemic and topical safety and tolerability of the topical patch formulations administered once daily for 4 days consecutive. 
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