PainPIS-PaBNCT06235320
Paracetamol Effect on Prostaglandins and Blood Pressure
An observational study of Pain, run by Charite University, Berlin, Germany.
Trial summary
This research program aims to investigate the influence of paracetamol on blood pressure and the cyclooxygenase (COX) - prostaglandine (PG) pathway in patients with pain. Through an observational pilot study, we will use advanced LC/ESI-MS/MS methodology to analyze the COX-OG pathway in plasma and urine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- routine clinical treatment of pain with paracetamol or ibuprofen
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Sep 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The first cohort consists of patients of the headache consultation at Charité Campus Mitte, where data is collected both within and outside of clinical routine, whereby the medical care of the respective patients takes place in the usual routine. The second cohort consists of patients attending oral surgery consultations at the Institute of Dentistry, Oral and Maxillofacial Surgery, for whom data is also collected both within and outside of clinical routine, whereby the medical care of the respective patients takes place in the usual routine.
Who may be able to join
- Headache and orosurgical patients treated at the respective charite outpatient clinic.
- Age 18 years or older
- Able to consent
- Patients with migraine type headache treated with paracetamol or ibuprofen within the last 12 hours or not treated with paracetamol or ibuprofen within the last 48 hours
- Patients treated with with paracetamol or ibuprofen undergoing orosurgery for wisedome tooth extraction
Who cannot join
- Pregnancy
- Arterial hypertension
- Use of beta blockers
- Use of COX inhibitors other than paracetamol or ibuprofen, including low-dose acetylsalicylic acid
- Stable prophylactic therapy of migraine for less than 3 weeks
- Use of tryptans in the last two days (Frovatriptane in the last 6 days)
- Oral surgery patients using paracetamol or ibuprofen in the last 24 hours
- Known allergy to paracetamol or ibuprofen
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Paracetamol Impact Study: Prostaglandin Synthesis and Blood Pressure Effects (PIS-PaB)
This research program aims to investigate the influence of paracetamol on blood pressure and the cyclooxygenase (COX) - prostaglandine (PG) pathway in patients with pain. Through an observational pilot study, we will use advanced LC/ESI-MS/MS methodology to analyze the COX-OG pathway in plasma and urine. The study will assess the effects of paracetamol compared to ibuprofen, considering different types of pain. The primary focus is to understand the changes in blood pressure and the COX-PG pathway upon initiation or discontinuation of paracetamol, with safety analysis as a secondary consideration.
- Conditions
- Pain
- Being tested
- routine clinical treatment of pain with paracetamol or ibuprofen
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine clinical treatment of pain with paracetamol or ibuprofenOther
No intervention beside clinical routine management
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol group | Not described Receives: Other: routine clinical treatment of pain with paracetamol or ibuprofen | |
| Ibuprofen group | Not described Receives: Other: routine clinical treatment of pain with paracetamol or ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostanoid levels
A comprehensive lipidomic analysis measuring the levels of prostanoids in plasma and spot urine samples using liquid chromatography tandem mass spectrometry (LC/ESI-MS/MS) technology in all participants.
Measured: just before treatment and 24 hours after treatment with paracetamol or ibuprofen
Secondary outcomes (1)
Blood pressure
Automated office and ambulatory blood pressure measurement
Measured: just before treatment and 24 hours after treatment with paracetamol or ibuprofen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engi Algharably, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235320
- Sponsor's protocol ID
- PIS-PaB
- Acronym
- PIS-PaB
- Status last verified
- Feb 2024
- First submitted
- 18 Jan 2024
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual patient data
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracetamol Impact Study: Prostaglandin Synthesis and Blood Pressure Effects (PIS-PaB)
- ClinicalTrials.gov ID
- NCT06235320
- Acronym / sponsor ID
- PIS-PaB / PIS-PaB
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 31 Jan 2024 (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.
This research program aims to investigate the influence of paracetamol on blood pressure and the cyclooxygenase (COX) - prostaglandine (PG) pathway in patients with pain. Through an observational pilot study, we will use advanced LC/ESI-MS/MS methodology to analyze the COX-OG pathway in plasma and urine. The study will assess the effects of paracetamol compared to ibuprofen, considering different types of pain. The primary focus is to understand the changes in blood pressure and the COX-PG pathway upon initiation or discontinuation of paracetamol, with safety analysis as a secondary consideration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol group | – | Other: routine clinical treatment of pain with paracetamol or ibuprofen |
| Ibuprofen group | – | Other: routine clinical treatment of pain with paracetamol or ibuprofen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The first cohort consists of patients of the headache consultation at Charité Campus Mitte, where data is collected both within and outside of clinical routine, whereby the medical care of the respective patients takes place in the usual routine. The second cohort consists of patients attending oral surgery consultations at the Institute of Dentistry, Oral and Maxillofacial Surgery, for whom data is also collected both within and outside of clinical routine, whereby the medical care of the respective patients takes place in the usual routine.
Key inclusion criteria (5 listed)
- Headache and orosurgical patients treated at the respective charite outpatient clinic.
- Age 18 years or older
- Able to consent
- Patients with migraine type headache treated with paracetamol or ibuprofen within the last 12 hours or not treated with paracetamol or ibuprofen within the last 48 hours
- Patients treated with with paracetamol or ibuprofen undergoing orosurgery for wisedome tooth extraction
Key exclusion criteria (8 listed)
- Pregnancy
- Arterial hypertension
- Use of beta blockers
- Use of COX inhibitors other than paracetamol or ibuprofen, including low-dose acetylsalicylic acid
- Stable prophylactic therapy of migraine for less than 3 weeks
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 |
|---|---|---|
| routine clinical treatment of pain with paracetamol or ibuprofenNo intervention beside clinical routine management | Other | Ibuprofen group, Paracetamol group |
Primary outcome
Prostanoid levels
Time frame: just before treatment and 24 hours after treatment with paracetamol or ibuprofen
A comprehensive lipidomic analysis measuring the levels of prostanoids in plasma and spot urine samples using liquid chromatography tandem mass spectrometry (LC/ESI-MS/MS) technology in all participants.
1 secondary outcome
Blood pressure
Time frame: just before treatment and 24 hours after treatment with paracetamol or ibuprofen
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: No. No plan to share individual patient data
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Charite University, Berlin, Germany.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Engi Algharably, PhD (030/ 450 525 221, engi.algharably@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostanoid levels (time frame: just before treatment and 24 hours after treatment with paracetamol or ibuprofen). 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 26 Feb 2025.