HypertensionPhase 4ParacetamolNCT02514538
EVALUATION OF THE RELATIONSHIP BETWEEN EFFERVESCENT PARACETAMOL AND BLOOD PRESSURE. CLINICAL TRIAL.
A Phase 4 study testing Non- effervescent Paracetamol kern and Effervescent paracetamol termalgin in people with Hypertension and Chronic Disease of Musculoskeletal System, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Chronic Disease of Musculoskeletal System
- What is being tested?
- Non- effervescent Paracetamol kern and Effervescent paracetamol termalgin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Jul 2015
- Phase
- Phase 4
- 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
Who may be able to join
- 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)
Who cannot join
- 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.
About this study
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)
Read the 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
- Being tested
- Non- effervescent Paracetamol kern, Effervescent paracetamol termalgin
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non- effervescent Paracetamol kernDrug
1g
Effervescent paracetamol termalginDrug
1 g
| Study group | Role | What they receive |
|---|---|---|
| Non-effervescent tablets | Experimental | 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). Receives: Drug: Non- effervescent Paracetamol kern; Drug: Effervescent paracetamol termalgin |
| Effervescent Paracetamol | Active comparator | 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). Receives: Drug: Non- effervescent Paracetamol kern; Drug: Effervescent paracetamol termalgin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startFeb 2012
- Primary completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514538
- Sponsor's protocol ID
- IJG-PAR-2010
- Acronym
- Paracetamol
- Status last verified
- Jul 2015
- First submitted
- 31 Jul 2015
- Last updated
- 3 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26654907
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE RELATIONSHIP BETWEEN EFFERVESCENT PARACETAMOL AND BLOOD PRESSURE. CLINICAL TRIAL.
- ClinicalTrials.gov ID
- NCT02514538
- Acronym / sponsor ID
- Paracetamol / IJG-PAR-2010
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2015 (actual)
- First posted
- 3 Aug 2015 (estimated)
- 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-effervescent tablets | Experimental | Drug: Non- effervescent Paracetamol kern, Drug: Effervescent paracetamol termalginComparing 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). |
| Effervescent Paracetamol | Active comparator | Drug: Non- effervescent Paracetamol kern, Drug: Effervescent paracetamol termalginComparing 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Non- effervescent Paracetamol kern1g | Drug | Effervescent Paracetamol, Non-effervescent tablets |
| Effervescent paracetamol termalgin1 g | Drug | Effervescent Paracetamol, Non-effervescent tablets |
Primary outcome
value of BP measured by ABPM
Time frame: 3 Weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
- Derived from this study: PubMed 26654907Benitez-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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Non- effervescent Paracetamol kern and Effervescent paracetamol termalgin in people with Hypertension and Chronic Disease of Musculoskeletal System, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
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 6 inclusion and 2 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 3 Aug 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
value of BP measured by ABPM (time frame: 3 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02514538, which also lists 1 linked publication.
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 3 Aug 2015.