DyspepsiaPhase 4NCT03635372
A Comparison of Effectiveness of Oral Sucrolfate, Alginate and Hydrotalcide in Dispeptic Pain Treatment
A Phase 4 study testing Alginate, Sucralfate and Hydrotalcite in people with Dyspepsia, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Dyspepsia is a very common but non-specific complaint that may indicate a group of symptoms that can be attributed to the upper gastrointestinal system, such as epigastric discomfort, abdominal bloating or fullness, stomach upset and nausea or vomiting that may be associated with food. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Alginate, Sucralfate and Hydrotalcite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2017to 25 Nov 2017
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Stomach pain, swelling or dispeptic complaints.
- Men and women between the ages of 18-60.
- Patients with VAS> 5.
Who cannot join
- Pregnancy and lactation.
- Sucralfate, alginate, hydrotalcite allergy.
- Emergency service arrives with acute psychiatric symptoms.
- Gastrointestinal system bleedings.
- Chronic renal failure, liver cirrhosis, structural and functional heart disease.
- Gastric malignancy and terminal illness.
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- Patients suspected of having a different problem such as ileus, biliary colic,
- pancreatitis, hepatitis.
- Patients who refuse to participate in the study.
- Those who can not use VAS.
- Presence of ischemic findings on the arrival ECG.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Effectiveness of Oral Sucrolfate, Alginate and Hydrotalcide in Dispeptic Pain Treatment: Randomized Trial
Dyspepsia is a very common but non-specific complaint that may indicate a group of symptoms that can be attributed to the upper gastrointestinal system, such as epigastric discomfort, abdominal bloating or fullness, stomach upset and nausea or vomiting that may be associated with food.
This study aimed to improve treatment management of patients with complaints of dyspeptic pain and emergency services, and to compare treatment efficacy of oral sucralfate, alginate and hydrotalcite, which are widely used in our country. Literature According to our research, our study is the first study to compare different antacids in our study of emergency serviste dyspepsia.
Read the detailed description
This study was performed prospectively, randomly, controlled, double-blind to compare the efficacy of oral sucralfate, alginate and hydrotalcite in patients presenting with emergency department dyspeptic complaints at Pamukkale University Medical Faculty Hospital Emergency Medicine Department.
Patients who were referred to the emergency department with stomach ache or dyspeptic complaints were taken to the study. Treatment medicines were applied according to the randomization scheme of the study patients.
This study was carried out in Pamukkale University Faculty of Medicine Emergency Medicine Department during 8 months between 01.03.2016 and 30.10.2016. Approximately 98,000 adult patients / year in the emergency department have a research assistant and / or faculty member who will check the research as a 24-hour primer. This study included 300 cases between 18 and 60 years of age who were admitted to our emergency department with dispeptic complaints, agreed to participate in the study, informed consent, and met inclusion criteria. The criteria for receiving and not receiving work were specified at the beginning of the study.
When appropriate patients were admitted to the study, the patient was taken to the emergency monitoring monitor and monitored once the written consent was obtained. Patients were assigned to one of the study groups according to the study number, according to the randomization scheme prepared by a non-emergency service computer. The numbers for the previously numbered workgroups were kept in unmarked envelopes and the envelope was opened by the study nurse to prepare the study medicine. The study medicines were prepared by an independent person who did not participate in the study or by the responsible work nurse who was at the helpline and was given to the patient by the other nurse. For each group, the drugs prepared in a 10 cc syringe were wrapped around the syringe with a color patch that did not show any similarity. When the medication was given to the patient, the patient's nose was closed and the drug smell was not taken. Patients were observed for 30 minutes in the emergency department and 30-minute VAS (Visual Analog Scale) score 5 and above were given to the patient for rescue treatment.
The information and data of the patients were collected by questionnaire. In the first part of the questionnaire, patients' demographic information address, telephone numbers, medical backgrounds, medications and vital findings were recorded. Detailed physical examinations of all patients were evaluated by emergency physician. Patients diagnosed with dyspepsia other than dyspepsia such as acute coronary syndrome, pancreatitis, cholecystitis, acute abdomen, ileus, malignancy and gastroenteritis were excluded as a result of history and physical examination. Patients who did not give their consent to participate were also excluded from the study. The patient with unexplained dyspepsia was directed to the gastroenterology polyclinic for endoscopy with necessary information. After discharge, patients were asked whether they had recurring epigastric pain within 24 hours.
- Conditions
- Dyspepsia
- Being tested
- Alginate, Sucralfate, Hydrotalcite
- Keywords
- Dyspepsia, Emergency Department, Antacid, Viscous Lidocaine
- Medical subject headings
- Dyspepsia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlginateDrug
Also called Gaviscon Lipuid
10 cc of Alginate peroral
SucralfateDrug
Also called Antepsin Suspension
10 cc of Sucralfate peroral
HydrotalciteDrug
Also called Talcid Suspension
10 cc of Hydrotalcite peroral
| Study group | Role | What they receive |
|---|---|---|
| Alginate | Experimental | 10 cc of Alginate peroral Receives: Drug: Alginate |
| Sucralfate | Experimental | 10 cc of Sucralfate peroral Receives: Drug: Sucralfate |
| Hydrotalcite | Experimental | 10 cc of Hydrotalcite peroral Receives: Drug: Hydrotalcite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of Gastric Pain
Compare relief of dispeptic complaint with using VAS (Visual Analog Scale) in 3 groups of alginate, sucralfate and hydrotalcite patients. Patients' pain scores were recorded using 0-100 mm VAS (Visual Analog Scale) to score the degree of dyspeptic complaints. VAS; It is composed of a measured horizontal or vertical line and often carries definitions of "no symptoms" on one end and "severe symptoms" on the other end. The patient is told to mark a point on the line according to the severity of the symptom. The location of the marker allows the severity of the symptom to be measured. The VAS markings on the evaluation forms prepared for the study before and during the procedure were made by the patient himself and regardless of the previous sign. Patients with VAS> 50 were treated. Patients were observed for 60 minutes in the emergency department and 60-minute VAS (Visual Analog Scale) score above 50 were given to the patient for rescue treatment.
Measured: Change from baseline in dispeptic complaint VAS scores at 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start20 Jun 2017
- Primary completion22 Oct 2017
- Study completion25 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bulent Erdur, Pamukkale University
- Investigators
- Gulgun Battal, MD, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635372
- Sponsor's protocol ID
- 2016TPF001
- Status last verified
- Aug 2018
- First submitted
- 15 Aug 2018
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Effectiveness of Oral Sucrolfate, Alginate and Hydrotalcide in Dispeptic Pain Treatment: Randomized Trial
- ClinicalTrials.gov ID
- NCT03635372
- Acronym / sponsor ID
- 2016TPF001
- Conditions
- Dyspepsia
- Keywords
- Dyspepsia, Emergency Department, Antacid, Viscous Lidocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 22 Oct 2017 (actual)
- Study completion
- 25 Nov 2017 (actual)
- First posted
- 17 Aug 2018 (actual)
- 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.
Dyspepsia is a very common but non-specific complaint that may indicate a group of symptoms that can be attributed to the upper gastrointestinal system, such as epigastric discomfort, abdominal bloating or fullness, stomach upset and nausea or vomiting that may be associated with food.
This study aimed to improve treatment management of patients with complaints of dyspeptic pain and emergency services, and to compare treatment efficacy of oral sucralfate, alginate and hydrotalcite, which are widely used in our country. Literature According to our research, our study is the first study to compare different antacids in our study of emergency serviste dyspepsia.
Detailed description
This study was performed prospectively, randomly, controlled, double-blind to compare the efficacy of oral sucralfate, alginate and hydrotalcite in patients presenting with emergency department dyspeptic complaints at Pamukkale University Medical Faculty Hospital Emergency Medicine Department.
Patients who were referred to the emergency department with stomach ache or dyspeptic complaints were taken to the study. Treatment medicines were applied according to the randomization scheme of the study patients.
This study was carried out in Pamukkale University Faculty of Medicine Emergency Medicine Department during 8 months between 01.03.2016 and 30.10.2016. Approximately 98,000 adult patients / year in the emergency department have a research assistant and / or faculty member who will check the research as a 24-hour primer. This study included 300 cases between 18 and 60 years of age who were admitted to our emergency department with dispeptic complaints, agreed to participate in the study, informed consent, and met inclusion criteria. The criteria for receiving and not receiving work were specified at the beginning of the study.
When appropriate patients were admitted to the study, the patient was taken to the emergency monitoring monitor and monitored once the written consent was obtained. Patients were assigned to one of the study groups according to the study number, according to the randomization scheme prepared by a non-emergency service computer. The numbers for the previously numbered workgroups were kept in unmarked envelopes and the envelope was opened by the study nurse to prepare the study medicine. The study medicines were prepared by an independent person who did not participate in the study or by the responsible work nurse who was at the helpline and was given to the patient by the other nurse. For each group, the drugs prepared in a 10 cc syringe were wrapped around the syringe with a color patch that did not show any similarity. When the medication was given to the patient, the patient's nose was closed and the drug smell was not taken. Patients were observed for 30 minutes in the emergency department and 30-minute VAS (Visual Analog Scale) score 5 and above were given to the patient for rescue treatment.
The information and data of the patients were collected by questionnaire. In the first part of the questionnaire, patients' demographic information address, telephone numbers, medical backgrounds, medications and vital findings were recorded. Detailed physical examinations of all patients were evaluated by emergency physician. Patients diagnosed with dyspepsia other than dyspepsia such as acute coronary syndrome, pancreatitis, cholecystitis, acute abdomen, ileus, malignancy and gastroenteritis were excluded as a result of history and physical examination. Patients who did not give their consent to participate were also excluded from the study. The patient with unexplained dyspepsia was directed to the gastroenterology polyclinic for endoscopy with necessary information. After discharge, patients were asked whether they had recurring epigastric pain within 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alginate | Experimental | Drug: Alginate10 cc of Alginate peroral |
| Sucralfate | Experimental | Drug: Sucralfate10 cc of Sucralfate peroral |
| Hydrotalcite | Experimental | Drug: Hydrotalcite10 cc of Hydrotalcite peroral |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Stomach pain, swelling or dispeptic complaints.
- Men and women between the ages of 18-60.
- Patients with VAS> 5.
Key exclusion criteria (11 listed)
- Pregnancy and lactation.
- Sucralfate, alginate, hydrotalcite allergy.
- Emergency service arrives with acute psychiatric symptoms.
- Gastrointestinal system bleedings.
- Chronic renal failure, liver cirrhosis, structural and functional heart disease.
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 |
|---|---|---|
| AlginateAlso: Gaviscon Lipuid10 cc of Alginate peroral | Drug | Alginate |
| SucralfateAlso: Antepsin Suspension10 cc of Sucralfate peroral | Drug | Sucralfate |
| HydrotalciteAlso: Talcid Suspension10 cc of Hydrotalcite peroral | Drug | Hydrotalcite |
Primary outcome
Relief of Gastric Pain
Time frame: Change from baseline in dispeptic complaint VAS scores at 60 minutes
Compare relief of dispeptic complaint with using VAS (Visual Analog Scale) in 3 groups of alginate, sucralfate and hydrotalcite patients. Patients' pain scores were recorded using 0-100 mm VAS (Visual Analog Scale) to score the degree of dyspeptic complaints. VAS; It is composed of a measured horizontal or vertical line and often carries definitions of "no symptoms" on one end and "severe symptoms" on the other end. The patient is told to mark a point on the line according to the severity of the symptom. The location of the marker allows the severity of the symptom to be measured. The VAS markings on the evaluation forms prepared for the study before and during the procedure were made by the patient himself and regardless of the previous sign. Patients with VAS> 50 were treated. Patients were observed for 60 minutes in the emergency department and 60-minute VAS (Visual Analog Scale) score above 50 were given to the patient for rescue treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Gulgun Battal, MD principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alginate, Sucralfate and Hydrotalcite in people with Dyspepsia, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 11 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: finished, as of the sponsor's last update on 31 Aug 2018. 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 Turkey (Türkiye). 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relief of Gastric Pain (time frame: Change from baseline in dispeptic complaint VAS scores at 60 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 31 Aug 2018.