Effect of CYP2C9*3 Polymorphism on Ibuprofen in Pakistani Population

Healthy Volunteers Clinical Trial

Official title:

Effect of CYP2C9*3 rs 1057910 Polymorphism on the Efficacy and Tolerability of Ibuprofen After Molar Tooth Extraction in Pakistani Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05983042
• Other study ID #: Riphah/IIMC/IRC/22/2072
• Status: Completed
• Start date: November 1, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this Observational 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.

Description:

The goal of this observational 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Genetic:
• Ibuprofen
Ibuprofen 400mg three times a day for three days

Locations

Country	Name	City	State
Pakistan	Ammarah Amjad	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the genetic variabilities in the clinical efficacy of ibuprofen after molar tooth extraction using a visual analog scale VAS	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).	three days
Secondary	To evaluate the genetic variabilities in the tolerability of ibuprofen after molar tooth extraction using the General Assessment of Side Effects GASE 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.	three days