Clinical trial to check safety and efficacy of Diclofenac Rectal Solution containing Diclofenac Sodium 50mg/squirt.

Phase 3

Completed

• Conditions: Health Condition 1: null- For relieving post operative pain

• Registration Number: CTRI/2018/02/012211
• Lead Sponsor: incoln Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-04-05
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

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.

Exclusion Criteria

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