Effect of CYP2C9*3 Polymorphism on Ibuprofen in Pakistani Population

Sponsor
Riphah International University (Other)
Overall Status
Completed
CT.gov ID
NCT05983042
Collaborator
(none)
200
1
8.9
22.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Ibuprofen

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effect of CYP2C9*3 rs 1057910 Polymorphism on the Efficacy and Tolerability of Ibuprofen After Molar Tooth Extraction in Pakistani Population
Actual Study Start Date :
Nov 1, 2022
Actual Primary Completion Date :
Jul 31, 2023
Actual Study Completion Date :
Jul 31, 2023

Outcome Measures

Primary Outcome Measures

  1. To evaluate the genetic variabilities in the clinical efficacy of ibuprofen after molar tooth extraction using a visual analog scale VAS [three days]

    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).

Secondary Outcome Measures

  1. To evaluate the genetic variabilities in the tolerability of ibuprofen after molar tooth extraction using the General Assessment of Side Effects GASE scale. [three days]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ammarah Amjad Rawalpindi Punjab Pakistan 46000

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Ammarah Amjad, BDS, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05983042
Other Study ID Numbers:
  • Riphah/IIMC/IRC/22/2072
First Posted:
Aug 9, 2023
Last Update Posted:
Aug 9, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2023