Clinical trial to check safety and efficacy of Diclofenac Rectal Solution containing Diclofenac Sodium 50mg/squirt.
- Conditions
- For relieving post operative pain
- Registration Number
- CTRI/2018/02/012211
- Lead Sponsor
- Lincoln Pharmaceuticals Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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
Trial Locations
- Locations (4)
AIIMS Bhubaneswar
🇮🇳Khordha, ORISSA, India
Civil Hospital
🇮🇳Ahmadabad, GUJARAT, India
DR B R Ambedkar Medical College
🇮🇳Bangalore, KARNATAKA, India
King George’s Medical University
🇮🇳Lucknow, UTTAR PRADESH, India
AIIMS Bhubaneswar🇮🇳Khordha, ORISSA, IndiaDr Tushar Subhdarshan MishraPrincipal investigator06742476789doctushar@gmail.com