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-type Headache.
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01012349
First received: November 12, 2009
Last updated: January 27, 2011
Last verified: October 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Treatment of Episodic Tension Headache |
Drug: Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965) Drug: Aspirin - Bayer |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
Primary Outcome Measures:
- The primary efficacy endpoint is the rate of sustained response (percentage of subjects who have no pain) two hours after the drug administration. [ Time Frame: 0, 30, 60, 90 and 120 minutes ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- • Reduction of associated symptoms (photophobia, phonophobia, nausea, vomiting); • Symptoms stomach before and after treatment • Change in gastric pH after administration; • Incidence of administration of rescue medications; • Change in pain [ Time Frame: 30, 60, 90 and 120 minutes after administration ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 152 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Test
Administration of GeoLab Association (acetylsalicylic acid, sodium bicarbonate and citric acid)
|
Drug: Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965)
1 tablet in an episody of headache
|
|
Active Comparator: Comparator
Acetylsalicylic acid - (Aspirin - Bayer)
|
Drug: Aspirin - Bayer
1 tablet in an episody of headache (Aspirin 500mg)
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Agreed to participate in the study expressed by signing the two copies of the informed consent and informed consent (IC) after approved by the IRB;
- Minimum age of 18 years;
- Clinical history of TTH, according to the criteria of the International Classification of Headache of the International Headache Society, in face of crisis.
Exclusion Criteria:
- Headache, migraine
- Chronic Tension-Type Headache (CTTH)
- Altered mental status
- Vital signs changed
- established or suspected pregnancy and lactation
- History of allergy to components of study drugs
- Current treatment with methotrexate
- Current treatment with Antinauseants
- Current treatment with anticoagulants such as heparin or coumarin-derivative
- gastric or duodenal disorders, chronic or recurrent active
- Liver and kidney disease severe
- Use of medications that have drug interactions with AAS
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012349
Contacts
| Contact: alexandre Frederico, physician | 55 19 3829-3822 | dr.alexandre@alclinica.com.br |
Locations
| Brazil | |
| Lal Clinica Pesquisa E Desenvolvimento Ltda | Not yet recruiting |
| Valinhos, SP, Brazil, 13270000 | |
| Contact: Alexandre Frederico, Physician 55 19 3829-3822 dr.alexandre@alclinica.com.br | |
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
More Information
No publications provided
| Responsible Party: | Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda |
| ClinicalTrials.gov Identifier: | NCT01012349 History of Changes |
| Other Study ID Numbers: | AASGEO0809, Version 2 |
| Study First Received: | November 12, 2009 |
| Last Updated: | January 27, 2011 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Additional relevant MeSH terms:
|
Headache Tension-Type Headache Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Aspirin Citric Acid Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013