Paracetamol Effect on Prostaglandins and Blood Pressure | NCT06235320

Studies
Paracetamol Effect on Prostaglandins and Blood Pressure

NCT06235320

Sponsor

Charite University, Berlin, Germany

Status

Not yet recruiting

Last Update Posted

Feb 26, 2025Actual

Enrollment

72Estimated

Phase

Not provided

Conditions

Pain

Interventions

routine clinical treatment of pain with paracetamol or ibuprofen

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2025Estimated

Primary Completion Date

Mar 1, 2026Estimated

Completion Date

Sep 1, 2026Estimated

First Submitted Date

Jan 18, 2024

First Submission Date that Met QC Criteria

Jan 30, 2024

First Posted Date

Jan 31, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2025

Last Update Posted Date

Feb 26, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Paracetamol group			Other: routine clinical treatment of pain with paracetamol or ibuprofen
Ibuprofen group			Other: routine clinical treatment of pain with paracetamol or ibuprofen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
routine clinical treatment of pain with paracetamol or ibuprofen	Other	No intervention beside clinical routine management	Ibuprofen group Paracetamol group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	just before treatment and 24 hours after treatment with paracetamol or ibuprofen

Secondary Outcomes

Measure	Description	Time Frame
Blood pressure	Automated office and ambulatory blood pressure measurement	just before treatment and 24 hours after treatment with paracetamol or ibuprofen

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Engi Algharably, PhD	Contact	030/ 450 525 221		engi.algharably@charite.de

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan to share individual patient data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000082	Acetaminophen
D007052	Ibuprofen

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814