Treatment of Episodic Tension HeadachePhase 2/3NCT01012349
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.
A Phase 2/3 study testing Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965) and Aspirin - Bayer in people with Treatment of Episodic Tension Headache, run by Azidus Brasil at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment of Episodic Tension Headache
- What is being tested?
- Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965) and Aspirin - Bayer
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2011to Aug 2011
- Phase
- Phase 2/3
- 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
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, 13270000
Alexandre Frederico, Physician, 55 19 3829-3822, dr.alexandre@alclinica.com.br
About this study
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.
Read the 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.
- Conditions
- Treatment of Episodic Tension Headache
- Being tested
- Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965), Aspirin - Bayer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965)Drug
1 tablet in an episody of headache
Aspirin - BayerDrug
1 tablet in an episody of headache (Aspirin 500mg)
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Administration of GeoLab Association (acetylsalicylic acid, sodium bicarbonate and citric acid) Receives: Drug: Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965) |
| Comparator | Active comparator | Acetylsalicylic acid - (Aspirin - Bayer) Receives: Drug: Aspirin - Bayer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is the rate of sustained response (percentage of subjects who have no pain) two hours after the drug administration.
Measured: 0, 30, 60, 90 and 120 minutes
Secondary outcomes (1)
• 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
Measured: 30, 60, 90 and 120 minutes after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startFeb 2011
- Primary completionMay 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Episodic Tension HeadacheStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012349
- Sponsor's protocol ID
- AASGEO0809
- Other IDs
- Version 2
- Status last verified
- Oct 2010
- First submitted
- 12 Nov 2009
- Last updated
- 28 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01012349
- Acronym / sponsor ID
- AASGEO0809
- Conditions
- Treatment of Episodic Tension Headache
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- May 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 13 Nov 2009 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965)Administration of GeoLab Association (acetylsalicylic acid, sodium bicarbonate and citric acid) |
| Comparator | Active comparator | Drug: Aspirin - BayerAcetylsalicylic acid - (Aspirin - Bayer) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- Headache, migraine
- Chronic Tension-Type Headache (CTTH)
- Altered mental status
- Vital signs changed
- established or suspected pregnancy and lactation
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 |
|---|---|---|
| Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965)1 tablet in an episody of headache | Drug | Test |
| Aspirin - Bayer1 tablet in an episody of headache (Aspirin 500mg) | Drug | Comparator |
Primary outcome
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
1 secondary outcome
• 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965) and Aspirin - Bayer in people with Treatment of Episodic Tension Headache, run by Azidus Brasil at 1 site in Brazil.
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 3 inclusion and 12 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 28 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact alexandre Frederico, physician (55 19 3829-3822, dr.alexandre@alclinica.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2011.