COMPARISON OF EFFICACY OF DIFFERENT DRUG COMBINATIONS IN ACUTE SCIATICA

NCT05626140 | Completed Phase 3

• 1 other identifier: PIMS-05-002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare different combinations of diclofenac with diclofenac monotherapy in acute sciatica. The main questions it aims to answer are:

• Does the combination of diclofenac plus codeine better than diclofenac monotherapy for treating severe pain of sciatica
• Does the combination of diclofenac plus lacosamide better than diclofenac monotherapy for treating severe pain of sciatica Participants will be asked to mark their pain intensity on a visual analog scale and fill oswestry disabilit index questionnaire,treatments they'll be given includes either
• Diclofenac monotherapy
• Diclofenac plus codeine
• Diclofenac plus lacosamide

Conditions

Sciatica Acute; Sciatica

Keywords

Acute Sciatica, Codeine, Diclofenac, Efficacy, Lacosamide

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  Severity of leg pain or lower back pain associated with acute sciatica to be assessed using the visual analog scale VAS to determine if the mean pain scores decreased during the course of the medication. VAS is a commonly used pain score in interventinal studies and evaluating pain intensity related with musculoskeletal disorders or post opertive types of pain. For this , the patient is asked to mark a line anywhere on a 10 cm line with 0 taken on the left edge. The mark drawn on the line corresponds to the intensity pf pain experienced by the patient at the time of the pain assessment

  Patients were asked to mark a line and record their pain scores at baseline and day 5, day 10 and day 15

Secondary Outcomes (1)

• Functional Disbability

  ODI was measured at baseline and days 5,10, and 15 and patients were asked to fill the questionnaire on the respective days

Other Outcomes (1)

• Use of Rescue Analgesia

  The use of rescue medication was determined on the final day of outcome i.e. Day 15

Study Arms (3)

Diclofenac plus placebo

PLACEBO COMPARATOR

Oral tablet diclofeanc sodium 50 mg was given with tab folic acid 5 mg as placebo ,12 hourly for 15 days

Drug: Diclofenac Sodium

Diclofenac plus codeine

ACTIVE COMPARATOR

Oral tablet diclofeanc sodium 50 mg was given with tab codeinephosphate 30 mg ,12 hourly for 15 days

Drug: Codeine Phosphate; Drug: Diclofenac Sodium

Diclofenac plus lacosamide

EXPERIMENTAL

Oral tablet diclofeanc sodium 50 mg was given with tab lacosamide 50 mg as placebo ,12 hourly for 15 days

Drug: Lacosamide 50 MG Oral Tablet [Vimpat]; Drug: Diclofenac Sodium

Interventions

Lacosamide 50 MG Oral Tablet [Vimpat] DRUG

Oral tablet lacosamide is a 3rd generation anti convulsant drug. it is given in a dose of 50 mg 12 hourly for 15 days. It has a longer half life than the other two drugs in comparison and fewer drug interactions as it doesnot interact with the hepatic cytochrome enzymes.hence it is seen to have better pharmacokinetics and pharmacodynamics than the other drugs in study

Also known as: Lacolap 50 mg, Vimpat 50 mg, Lalap 50 mg

Diclofenac plus lacosamide

Codeine Phosphate DRUG

Oral Codeine Phophate is an opioid with centrally acting pain alleviating mechanisms, shorter half life and metabolized to morphine in he body which is its active metabolite

Diclofenac plus codeine

Diclofenac Sodium DRUG

Diclofenac sodium is a Cox 2 inhibitor non steroidal anti inflammatory drug with a half life of only 1.2 hrs but a longer action of duration due to its property to get distributed to synovial fluids. metabolized to hydroxy diclofenac and excreted via urine and bile both.

Also known as: Artifen 50 mg, Dicloran 50 mg

Diclofenac plus codeine; Diclofenac plus lacosamide; Diclofenac plus placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with acute sciatica with or without lower back pain
• years of age reporting acute pain due to sciatica

You may not qualify if:

• Pregnant or breastfeeding mothers.
• History of asthma or allergy to anti-inflammatory drugs.
• Mentally handicapped or terminally ill patients.
• Age less than 18 years or above 70 years
• Patients with herniated, sequestrated, or prolapsed discs waiting for surgery.
• Patient having an active ulcer (gastric or duodenal) or bleeding from the stomach or bowel.
• Patients already taking an anti-depressant medication, a medication for neuropathic pain, an anticonvulsant, or a sedative and unable to cease the medication

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead
• Riphah International University: collaborator

Study Sites (1)

Mehreen Mirza

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Sciatica

Interventions

Lacosamide; Tablets; Codeine; Diclofenac; dicloran

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Dosage Forms; Pharmaceutical Preparations; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Phenylacetates; Acids, Carbocyclic

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Trainee/ Prinicipal Investigator

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: September 28, 2021
• Primary Completion: May 31, 2022
• Study Completion: July 31, 2022
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)