Healthy VolunteersNCT05983042
Effect of CYP2C9*3 Polymorphism on Ibuprofen in Pakistani Population
An observational study of Healthy Volunteers, run by Riphah International University at 1 site in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Ibuprofen 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2022to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Individuals who were advised for molar tooth extractions based on orthodontic, periodontal, and endodontic indications
Who may be able to join
- Pakistani individuals
- Absence of systemic diseases
- Extractions required based on orthodontic, periodontal, and endodontic indications
Who cannot join
- history of bleeding or gastrointestinal ulcers
- allergic to ibuprofen or other NSAIDs.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of CYP2C9*3 rs 1057910 Polymorphism on the Efficacy and Tolerability of Ibuprofen After Molar Tooth Extraction 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.
Read the detailed description
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.
- Conditions
- Healthy Volunteers
- Being tested
- Ibuprofen 400 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 400 mgDrug
Ibuprofen 400 mg TDS
PlaceboDrug
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Ibuprofen 400mg TDS Receives: Drug: Ibuprofen 400 mg | |
| Placebo | Tab Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: three days
Secondary outcomes (1)
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.
Measured: three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Nov 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ammarah Amjad, BDS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983042
- Sponsor's protocol ID
- Riphah/IIMC/IRC/22/2072
- Status last verified
- Jun 2026
- First submitted
- 1 Aug 2023
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CYP2C9*3 rs 1057910 Polymorphism on the Efficacy and Tolerability of Ibuprofen After Molar Tooth Extraction in Pakistani Population
- ClinicalTrials.gov ID
- NCT05983042
- Acronym / sponsor ID
- Riphah/IIMC/IRC/22/2072
- Conditions
- Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | – | Drug: Ibuprofen 400 mgIbuprofen 400mg TDS |
| Placebo | – | Drug: PlaceboTab Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Individuals who were advised for molar tooth extractions based on orthodontic, periodontal, and endodontic indications
Key inclusion criteria (3 listed)
- Pakistani individuals
- Absence of systemic diseases
- Extractions required based on orthodontic, periodontal, and endodontic indications
Key exclusion criteria (3 listed)
- history of bleeding or gastrointestinal ulcers
- allergic to ibuprofen or other NSAIDs.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen 400 mgIbuprofen 400 mg TDS | Drug | Ibuprofen |
| PlaceboPlacebo tablet | Drug | Placebo |
Primary outcome
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).
1 secondary outcome
General Assessment of Side Effects scale
Time frame: three days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ammarah Amjad, BDS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.