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EVALUATION OF THE RELATIONSHIP BETWEEN EFFERVESCENT PARACETAMOL AND BLOOD PRESSURE. CLINICAL TRIAL. (Paracetamol)

Primary Purpose

Hypertension, Chronic Disease of Musculoskeletal System

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Non- effervescent Paracetamol kern

Effervescent paracetamol termalgin

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients included in the study must meet the following criteria:
be hypertensive patients over 18 years
with degenerative joint disease
which regularly need analgesic treatment. They must submit BP in the consultation lower than 150 and 95 mmHg or lower than 135 and 85 mmHg if they have associated cardiovascular disease (stroke, coronary heart disease, peripheral arterial disease) or diabetes mellitus.

They can't receive pharmacological antihypertensive treatment, or this must be stable and unchanged in the last month.

In relation to degenerative joint disease, they should have a degree of mild to moderate pain, with a score between 1 and 4 on a visual analog scale (VAS)

Exclusion Criteria:

Patients with allergy, intolerance or contraindication to paracetamol or tramadol will be excluded, as those who have taken nonsteroidal antiinflammatory drugs (NSAIDs) orally or parenterally in the last week, or have a high degree of pain (VAS> 4) or poorly controlled hypertension (office BP> 150/95 mmHg or daytime ambulatory mean BP > 140/90 mmHg).

Patients with heart failure due to systolic and / or diastolic dysfunction will also be excluded, those who have suffered a cardiovascular event (myocardial infarction, unstable angina or stroke of any type) in the last 6 months, presenting sleep apnea or any form of secondary hypertension, elevated transaminases (higher than 3 times normal value), or a glomerular filtration rate <30 ml/min, over a maximum period of three months before starting the study; patients with dementia or judicial disability, with alcoholism or other addictions; pregnant patients; patients treated with oral anticoagulants or subcutaneous heparin. Patients in which changes are foreseen in usual dose drugs with effects on BP throughout the study (alpha blockers, tricyclic antidepressants, beta blockers in eye drops, sympathomimetic vasoconstrictor, other effervescent agents, hormonal contraceptives, NSAIDs, corticosteroids, anabolic, erythropoietin, cyclosporine) or those who will initiate major changes in lifestyles (onset or increase physical exercise, dietary changes); those who do not give their informed consent and that in the opinion of the investigator, have poor adherence or may become lost to follow-up.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Non-effervescent tablets

Effervescent Paracetamol

Arm Description

Comparing the effect of two different formulations of paracetamol (effervescent or non-effervescent tablets) in the blood pressure of hypertensive patients after 3 weeks treatment . The washing time between the two periods is approximately 1 week (minimum 3 days).

Outcomes

Primary Outcome Measures

value of BP measured by ABPM

The primary endpoint is the change in mean daytime, night-time (sleep) and 24-hour systolic BP, measured by ABPM, from baseline at 3 weeks of treatment in both periods.

Secondary Outcome Measures

Full Information

NCT ID

NCT02514538

First Posted

July 31, 2015

Last Updated

July 31, 2015

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

1. Study Identification

Unique Protocol Identification Number

NCT02514538

Brief Title

EVALUATION OF THE RELATIONSHIP BETWEEN EFFERVESCENT PARACETAMOL AND BLOOD PRESSURE. CLINICAL TRIAL.

Acronym

Paracetamol

Official Title

EVALUATION OF THE RELATIONSHIP BETWEEN EFFERVESCENT PARACETAMOL AND BLOOD PRESSURE. CLINICAL TRIAL.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Unknown status

Study Start Date

February 2012 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Paracetamol's solubility is achieved by adding to the excipient sodium salts, either as bicarbonate, carbonate or citrate. As the relationship between salt and hypertension is well known, due to the sodium content it has raised a hypothesis that may interfere with the control of that risk factor. Therefore, the objective of this study is to evaluate the effect on blood pressure of effervescent paracetamol compared to non-effervescent, in hypertensive patients. This is a multicenter, randomized, controlled, crossover, open, phase IV clinical trial, which compares the effect of two different formulations of paracetamol (effervescent or non-effervescent tablets) in the blood pressure of hypertensive patients after 3 weeks treatment (coded EUDRACT 2010-023485-53). The washing time between the two periods is approximately 1 week (minimum 3 days)

Detailed Description

Inclusion criteria: Patients included in the study must meet the following criteria: be hypertensive patients over 18 years with degenerative joint disease which regularly need analgesic treatment. They must submit BP in the consultation lower than 150 and 95 mmHg or lower than 135 and 85 mmHg if they have associated cardiovascular disease (stroke, coronary heart disease, peripheral arterial disease) or diabetes mellitus. They can't receive pharmacological antihypertensive treatment, or this must be stable and unchanged in the last month. In relation to osteoarticular disease, they should have a degree of mild to moderate pain, with a score between 1 and 4 on a visual analog scale (VAS) Evaluation of results Primary endpoint: The primary endpoint is the change in mean daytime, night-time (sleep) and 24-hour systolic BP, measured by ABPM, from baseline at 3 weeks of treatment in both periods. Secondary endpoints: Changes in systolic BP measured in the clinic at the end of 3-week follow-up respect baseline in both periods. 24-hour, daytime and night-time (sleep) diastolic BP measured by ABPM: change from baseline at 3 weeks of treatment in both periods Changes in diastolic BP measured in the clinic at the end of 3-week follow-up respect baseline in both periods. Percentage of patients maintaining clinical BP under 140 and 90 mmHg at the end of each period Degree of pain assessed by visual analog scale Consumption of rescue medication Therapeutic compliance

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Chronic Disease of Musculoskeletal System

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Non-effervescent tablets

Arm Type

Experimental

Arm Description

Arm Title

Effervescent Paracetamol

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Non- effervescent Paracetamol kern

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Effervescent paracetamol termalgin

Intervention Description

1 g

Primary Outcome Measure Information:

Title

value of BP measured by ABPM

Description

The primary endpoint is the change in mean daytime, night-time (sleep) and 24-hour systolic BP, measured by ABPM, from baseline at 3 weeks of treatment in both periods.

Time Frame

3 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients included in the study must meet the following criteria: be hypertensive patients over 18 years with degenerative joint disease which regularly need analgesic treatment. They must submit BP in the consultation lower than 150 and 95 mmHg or lower than 135 and 85 mmHg if they have associated cardiovascular disease (stroke, coronary heart disease, peripheral arterial disease) or diabetes mellitus. They can't receive pharmacological antihypertensive treatment, or this must be stable and unchanged in the last month. In relation to degenerative joint disease, they should have a degree of mild to moderate pain, with a score between 1 and 4 on a visual analog scale (VAS) Exclusion Criteria: Patients with allergy, intolerance or contraindication to paracetamol or tramadol will be excluded, as those who have taken nonsteroidal antiinflammatory drugs (NSAIDs) orally or parenterally in the last week, or have a high degree of pain (VAS> 4) or poorly controlled hypertension (office BP> 150/95 mmHg or daytime ambulatory mean BP > 140/90 mmHg). Patients with heart failure due to systolic and / or diastolic dysfunction will also be excluded, those who have suffered a cardiovascular event (myocardial infarction, unstable angina or stroke of any type) in the last 6 months, presenting sleep apnea or any form of secondary hypertension, elevated transaminases (higher than 3 times normal value), or a glomerular filtration rate <30 ml/min, over a maximum period of three months before starting the study; patients with dementia or judicial disability, with alcoholism or other addictions; pregnant patients; patients treated with oral anticoagulants or subcutaneous heparin. Patients in which changes are foreseen in usual dose drugs with effects on BP throughout the study (alpha blockers, tricyclic antidepressants, beta blockers in eye drops, sympathomimetic vasoconstrictor, other effervescent agents, hormonal contraceptives, NSAIDs, corticosteroids, anabolic, erythropoietin, cyclosporine) or those who will initiate major changes in lifestyles (onset or increase physical exercise, dietary changes); those who do not give their informed consent and that in the opinion of the investigator, have poor adherence or may become lost to follow-up.

12. IPD Sharing Statement

Citations:

PubMed Identifier

26654907

Citation

Benitez-Camps M, Vinyoles-Bargallo E, Rebagliato-Nadal O, Morros-Pedros R, Pera-Pujadas H, Dalfo-Baque A, Lopez-Pavon I, Roca-Sanchez C, Coma-Carbo RM, De La Figuera Von Wichmann M, Mengual-Martinez L, Yuste-Marco C, Teixido-Colet M, Pepio i Vilaubi JM, Ciurana-Tost R, Pou-Vila R, Vila-Coll MA, Bordas-Julve JM, Aragones-Fores R, Pelegrina-Rodriguez FJ, Agudo-Ugena J, Blanco-Mata C, de la Iglesia Berrojalbiz J, Burgos-Alonso N, Gomez-Fernandez MC. Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial. BMC Cardiovasc Disord. 2015 Dec 10;15:167. doi: 10.1186/s12872-015-0161-7.

Results Reference

derived

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EVALUATION OF THE RELATIONSHIP BETWEEN EFFERVESCENT PARACETAMOL AND BLOOD PRESSURE. CLINICAL TRIAL.

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