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OpenTrials
Completed

NCT Number: NCT05983042

Effect of CYP2C9*3 Polymorphism on Ibuprofen in Pakistani Population

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ammarah Amjad

Rawalpindi, Punjab Province, 46000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen 400 mg

Drug

Ibuprofen 400 mg TDS

Placebo

Drug

Placebo tablet

Primary outcomes

  1. Visual Analogue Scale

    Time frame: 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 outcomes

  1. General Assessment of Side Effects scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 9, 2023
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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