Advertisement

Topics

Efficacy and Safety Clinical Trial of the Combination of Acetylsalicylic Acid, Sodium Bicarbonate and Citric Acid, Produced by Geolab Pharmaceutical Industries Ltd., Compared to Acetylsalicylic Acid (Aspirin ® - Bayer) in Patients With Episodic Tension-t

2014-08-27 03:18:02 | BioPortfolio

Summary

This study aims is to evaluate, two hours after a single administration, the rate of sustained response produced by the association Geolab consisting of acetylsalicylic acid, sodium bicarbonate and anhydrous citric acid - oral powder, with the active comparator acetylsalicylic acid (Aspirin ® -- Bayer) - a simple tablet for the treatment of acute pain in patients with mild to moderate CTTE, using for both the visual analog scale pain - VAS.

Description

The secondary objectives of the study are to evaluate:

- Modification of gastric pH after administration of drugs by measuring with gastroesophageal pH Monitor, comparing the results between the groups;

- The incidence of administration of rescue medications, through the accounts of patients and researchers, comparing the results between the groups;

- The percentage of improvement in time 30, 60, 90 and 120 minutes after administration, using the visual analog scale (VAS), comparing the results between the groups;

- Evaluate the gastric symptoms before and after treatment by clinical investigation of patients, comparing the results between the groups;

- Evaluate the change in associated symptoms (photophobia, phonophobia, nausea, vomiting), using 4-point scale (0 - absent 1 - mild 2 - moderate 3 - severe), comparing the results between the groups;

- Assess the quantitative and qualitative parameters related to adverse reactions, comparing the results between the groups.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Treatment of Episodic Tension Headache

Intervention

Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965), Aspirin - Bayer

Location

Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos
SP
Brazil
13270000

Status

Not yet recruiting

Source

L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:02-0400

Clinical Trials [2020 Associated Clinical Trials listed on BioPortfolio]

Effects of Oral Sodium Bicarbonate Supplementation in Haemodialysis Patients (BicHD)

The purpose of the study is to investigate whether oral sodium bicarbonate supplementation to ensure a constant bicarbonate profile in haemodialysis patients will primarily lower predialys...

A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(COMPLETED)

Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will h...

Arterial pH and N-Balances in APD

This study will test the hypothesis that by slightly lowering the acidity of blood (or increasing the pH), dialysis patients utilize protein and amino acids more efficiently.

A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy

The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects undergoing col...

The Efficiency and Safety of Sodium Bicarbonate on Uric Acid in Patients With Asymptomatic Hyperuricemia or Gout

This study evaluate the serum uric acid lowering effect of sodium bicarbonate as well as its safety in patients with asymptomatic hyperuricemia or gout. Half of the participants will recei...

PubMed Articles [17824 Associated PubMed Articles listed on BioPortfolio]

Potential of using sodium bicarbonate as external carbon source to cultivate microalga in non-sterile condition.

In this study, a saline-alkaline tolerant microalgal strain was isolated and identified as Chlorella sp. LPF. This strain was able to grow at pH values up to 10 and at salinities up to 5%, and tolerat...

Acetylsalicylic acid decreases clotting in combination with enoxaparin during haemodialysis in vitro.

Anticoagulation is a cornerstone in haemodialysis (HD) therapy to avoid clotting of blood when it comes into contact with the dialysis membrane. Although heparins are usually administered as anticoagu...

Sodium bicarbonate cotransporter NBCe2 gene variants increase sodium and bicarbonate transport in human renal proximal tubule cells.

Salt sensitivity of blood pressure affects >30% of the hypertensive and >15% of the normotensive population. Variants of the electrogenic sodium bicarbonate cotransporter NBCe2 gene, SLC4A5, are assoc...

Dosage forms and doses of acetylsalicylic acid: significance for clinical practice.

The article presents a review of pharmacokinetics and pharmacodynamics of different acetylsalicylic acid (ASA) dosage forms. The review showed that efficacy and safety of ASA are determined by its sys...

The Effect of pH on Citric Acid Cough Challenge: A Randomised Control Trial in Chronic Cough and Healthy Volunteers.

Citric acid has been used for over six decades to induce cough; however the mechanism of its pro-tussive effect is still not fully understood. We assessed the response to inhalation of citric acid at ...

Medical and Biotech [MESH] Definitions

Bicarbonate transporters that move BICARBONATE IONS in exchange of CHLORIDE IONS or SODIUM IONS across membranes. They regulate acid-base HOMEOSTASIS, cell volume and intracellular pH. Members include CHLORIDE-BICARBONATE ANTIPORTERS (SLC4A1, 2, 3, and 9); SODIUM-COUPLED BICARBONATE TRANSPORTERS (SLC4A4 and 5, 7, 8 and 10); and a sodium borate cotransporter (SLC4A11 protein).

Proteins that cotransport sodium ions and bicarbonate ions across cellular membranes.

A key intermediate in metabolism. It is an acid compound found in citrus fruits. The salts of citric acid (citrates) can be used as anticoagulants due to their calcium chelating ability.

An antitubercular agent often administered in association with ISONIAZID. The sodium salt of the drug is better tolerated than the free acid.

Membrane proteins that allow the exchange of chloride ions for bicarbonate ions across the cellular membrane. The action of specific antiporters in this class serve important functions such as allowing the efficient exchange of bicarbonate across red blood cell membranes as they passage through capillaries and the reabsorption of bicarbonate ions by the kidney.

More From BioPortfolio on "Efficacy and Safety Clinical Trial of the Combination of Acetylsalicylic Acid, Sodium Bicarbonate and Citric Acid, Produced by Geolab Pharmaceutical Industries Ltd., Compared to Acetylsalicylic Acid (Aspirin ® - Bayer) in Patients With Episodic Tension-t"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...


Searches Linking to this Trial