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CTRI Number  CTRI/2018/02/012211 [Registered on: 28/02/2018] Trial Registered Retrospectively
Last Modified On: 11/05/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical trial to check safety and efficacy of Diclofenac Rectal Solution containing Diclofenac Sodium 50mg/squirt. 
Scientific Title of Study   AN OPEN-LABEL, RANDOMIZED, COMPARATIVE, MULTICENTRIC, PARALLEL GROUP, PHASE-III STUDY TO COMPARE THE EFFICACY AND SAFETY OF TWO SQUIRTS OF DICLOFENAC RECTAL SOLUTION WITH APPLICATOR (DICLOFENAC SODIUM 50 mg/squirt) OF LINCOLN PHARMACEUTICALS LTD, INDIA WITH JONAC SUPPOSITORY (DICLOFENAC SODIUM 100 mg) OF GERMAN REMEDIES (CADILA HEALTHCARE LTD.) IN PATIENTS WITH POST-OPERATIVE PAIN 
Trial Acronym  - 
Secondary IDs if Any  
Secondary ID  Identifier 
STPL/CT/DCGI/004/2015-Version3.0 Dated 25June2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajnish Patel 
Designation  M S General Surgery 
Affiliation  B.J Medical college and Civil Hospital 
Address  Department of General Surgery B.J Medical college and Civil Hospital Asarwa Ahmedabad
32 Asmita Society Maninagar East
Ahmadabad
GUJARAT
380008
India 
Phone  07922680074  
Fax  07922683067  
Email  drrajnishpatel@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Kapil Pandya 
Designation  Technical Director 
Affiliation  Synergist Therapeutic Pvt Ltd 
Address  G/704 Titanium City Center 100 Feet Anandnagar Road Near Sachin Tower Satellite Ahmedabad
G/704 Titanium City Center 100 Feet Anandnagar Road Near Sachin Tower Satellite Ahmedabad
Ahmadabad
GUJARAT
380015
India 
Phone  91-79-4005-0983  
Fax  91-79-4005-0983  
Email  kapil@synergistservices.com  
 
Details of Contact Person
Public Query  
Name  Mr Kapil Pandya 
Designation  Technical Director 
Affiliation  Synergist Therapeutic Pvt Ltd 
Address  G/704 Titanium City Center 100 Feet Anandnagar Road Near Sachin Tower Satellite Ahmedabad
G/704 Titanium City Center 100 Feet Anandnagar Road Near Sachin Tower Satellite Ahmedabad
Ahmadabad
GUJARAT
380015
India 
Phone  91-79-4005-0983  
Fax  91-79-4005-0983  
Email  kapil@synergistservices.com  
 
Source of Monetary or Material Support  
Lincoln Pharmaceuticals Ltd Lincoln Pharmaceuticals Ltd Trimul Estate Khatraj Tal Kalol Dist Gandhinagar Gujarat 
 
Primary Sponsor  
Name  Lincoln Pharmaceuticals Ltd 
Address  Lincoln Pharmaceuticals Ltd Trimul Estate Khatraj Tal Kalol Dist Gandhinagar Gujarat 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tushar Subhdarshan Mishra  AIIMS Bhubaneswar   AIIMS Bhubaneswar Department of surgery AIIMS Bhubaneswar Sijua Patrapada Odisha
Khordha
ORISSA 		 06742476789
06742472215
doctushar@gmail.com 
Dr Rajnish R Patel  Civil Hospital  Room no-102 B J Medical College and Civil Hospital Ahmedabad west
Ahmadabad
GUJARAT 		 79-2272-0605

drrajnishpatel@hotmail.com 
Dr B S Ramesh  DR B R Ambedkar Medical College  DR B R Ambedkar Medical College Department of general surgery Kadugondanahalli, Bangalore
Bangalore
KARNATAKA 		 9845472444
07922683067
colonelbsr@gmail.com 
Dr Sandeep Tiwari  King George’s Medical University  King George’s Medical University Department of Surgery , Lucknow 226003
Lucknow
UTTAR PRADESH 		 05222257540
915222257539
sandeep_neelu@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
B.J Medical college and Civil Hospital  Approved 
Dr.B.R.Ambedkar Medical College  Approved 
IEC-AIIMS  Approved 
King Georges Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  For relieving post operative pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  JONAC SUPPOSITORY (DICLOFENAC SODIUM 100 mg)  One squirts(solutionof 100mg of JONAC suppository 
Intervention  Rectal Solution with applicator(Diclofenac sodium 50mg/squirt)  two squirts(solution) of (Diclofenac sodium 50mg/squirt) 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.patients undergoing elective day open surgery i.e. Hernia or Standard Appendectomy
2.Patients undergoing surgical operation with SPINAL anesthesia
3.Patients who have signed and dated their written informed consent prior to initiation of study. 
 
ExclusionCriteria 
Details  1.Patients with psychiatric or mental diseases, or unable to follow the requests of the protocol including comprehension of VAS procedure
2.Known or suspected hypersensitivity to Diclofenac sodium or tramadol
3.Patient with any condition which in the opinion of the investigator makes the patients unsuitable for inclusion
4.Patients with a history of malignancy, epilepsy, hematological disorders, hepatic or renal insufficiency, peptic ulcer or active GI bleeding, chronic pain, long-term steroid therapy or continuous usage of analgesic drugs, relevant drug allergies or asthma, uncontrolled hypertension, neurologic or psychological disorders, alcohol abuse, opium addict or using any drug that modifies pain perception and inability to tolerate rectal sodium diclofenac are excluded from the study
5.Patients with active or history of recurrent rectal bleeding or hemorrhage.
6.Patients with any inflammatory lesions of rectum or anus
7.Patients with hypervolemia or dehydration from any cause
8.Patients with Severe heart failure
9.Patients with history of haemorrhagic diathesis or confirmed or suspected cerebrovascular bleeding
10.Patients with prolonged operations associated with a risk of haemorrhage
11.The outpatients will be excluded from the study
12.Patients without the ability to comply with the study protocol and complete the study in the judgment of the investigator
13.Pregnant or breast feeding women
14.Females of child bearing potential, not taking adequate contraception
15.Any condition or situation which, in the opinion of the investigator, might pose a risk to the subject or interfere with participation in the study like history of bronchial asthma

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Postoperative pain assessment with VAS(Visual Analogue Scale)score ranges from 0 to 10   Postoperative pain assessment all patients will undergo efficacy measurement over VAS(Visual Analogue Scale)range 0-10 at 0.5,1,1.5,2,6,12 and 24 hours after dosing  
 
Secondary Outcome  
Outcome  TimePoints 
Safety outcome will be measured as spontaneously reported and directly observed Adverse Events(AEs)after administered dose until post treatment follow up  Safety of patients will be evaluated by vital signs (temperature, blood pressure, Pulse rate and respiratory rate) and monitoring adverse events during study period at 0.5,1,1.5,2,6,12 and 24 hours 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   02/08/2017 
Date of Study Completion (India) 05/04/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Proposed study is Open-Label, Randomized, Comparative, Multicentric,Parallel group Phase-III The primary objective of the study was to assess comparative bio-availability of Diclofenac rectal solution 100 mg / 0.4 ml with Jonac suppository 100 mg of Cadila Healthcare in 16 healthy subjects. Based on comparative pharmacokinetic profile, it was concluded that the test formulation of diclofenac rectal solution was available early in the systematic circulation as compared to suppository. Tmax of diclofenac rectal solution was observed to be 0.62 hrs as compared to 1.13c hours of suppository. The overall conclusion was that diclofenac rectal solution is showing faster release profile with little higher Cmax and higher bioavailability. During the study all the study subjects were monitored for safety aspects too. There was no safety concerns observed.

Study Design: Eligible patients as per inclusion and exclusion criteria will be randomly allocated into two groups. Group A (N=50) patients will receive two squirts (Solution) of (Diclofenac sodium 50 mg/squirt). Group B (N=50) patients will receive 100 mg of JONAC Suppository at three hours + 30 minutes of Bupivacaine heavy administration,when analgesic effect of Bupivacaine heavy weans off and patient complaints of pain. The pain score wil be recorded on VAS as a baseline score. If the patient exhibited VAS pain score more than 4 at anytime point, rescue analgesic i.m. tramadol 1-2 mg/kg will be administered as per patient pain severity.Systemic Adverse Reactions and Rescue Medication requirement shall be assessed for both arm.

As this particular drug delivery system of dicofenac (rectal solution with applicator) have not been used anywhere in the world in patients, a Phase-III study is proposed to be conducted on patients undergoing elective surgical procedure to treat post-operative pain and to establish ease and convenience of use of diclofenac rectal solution in clinical practice. The trial also aims to confirm preliminary evidence of Therapeutic Equivalence or superiority with respect to efficacy and safety results in patients as observed during pharmacokinetic study in healthy subjects.

 
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