Effect of CYP2C9*3 Polymorphism on Ibuprofen in Pakistani Population

Riphah International University200 enrolled

Overview

The goal of the study was to identify the effect of CYP2C9 gene polymorphism in the Pakistani population. The main question it aims to answer were: * to evaluate the effect of this genetic polymorphism on the clinical efficacy of Ibuprofen * to evaluate the effect of this genetic polymorphism on the clinical tolerability of Ibuprofen Participants were prescribed Ibuprofen after molar tooth extraction.

The goal of this study was to identify the effect of CYP2C9\*3 gene polymorphism in the Pakistani population, due to the high prevalence of this variant in the Pakistani Population The main question it aims to answer were: * to evaluate the effect of this genetic polymorphism on the clinical efficacy of Ibuprofen * to evaluate the effect of this genetic polymorphism on the clinical tolerability of Ibuprofen Participants were prescribed Ibuprofen after molar tooth extraction. The blood samples of the participants were taken and further genotyping was performed using conventional tetraARMS PCR. The results were visualized by gel electrophoresis.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Healthy Volunteers

Interventions

Ibuprofen 400 mgDRUG

Ibuprofen 400 mg TDS

PlaceboDRUG

Placebo tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pakistani individuals * Absence of systemic diseases * Extractions required based on orthodontic, periodontal, and endodontic indications Exclusion Criteria: * history of bleeding or gastrointestinal ulcers * allergic to ibuprofen or other NSAIDs. * Pregnancy

Locations (1)

Ammarah Amjad

Rawalpindi, Punjab Province, Pakistan

Outcomes

Primary Outcomes

Visual Analogue Scale

A Visual Analogue Scale (VAS) is one of the self-administered pain rating scales, to measure pain intensity. The pain was interpreted as no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).

Time frame: three days

Secondary Outcomes

General Assessment of Side Effects scale

The self-rating scale General Assessment of Side Effects (GASE), is about the most frequent side effects in clinical trials of different drugs. Every symptom (dyspepsia, nausea, diarrhea) had to be answered twice: first, participants had to rate the intensity of this symptom during the last 3 days, and second, if this symptom was present, participants had to rate whether they attribute it to current drug intake.

Time frame: three days

Data from ClinicalTrials.gov

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