DyspepsiaPhase 4NCT06241183
Famotidine and Antacids for Treatment of Dyspepsia
A Phase 4 study testing Intravenous Famotidine and Oral Maalox/ Mylanta in people with Dyspepsia and GERD, run by Stony Brook University at 1 site in United States.
Trial summary
The aim of this study is to compare intravenous famotidine, an H2 receptor antagonist, and Maalox/ Mylanta, an oral antacid, in treatment of dyspepsia in the emergency department. The goal of this study is to reduce patients' pain based on the verbal numerical pain scale. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspepsia, GERD, Acid Reflux
- What is being tested?
- Intravenous Famotidine and Oral Maalox/ Mylanta
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2023to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Subject Age ≥ 18 years of age
- Patient diagnosed with dyspepsia
- Present at the ED with upper abdominal pain score of at least 3
Who cannot join
- Hypersensitivity to an ingredient in Maalox/ Mylanta or Famotidine
- Moderate to Severe Renal Insufficiency (precaution)
- Kidney Failure
- Pregnant or Nursing
- Verbal pain score less than 3
- Inability to tolerate oral medications
- Bowel Obstruction
- Proton pump inhibitor within 2 hours of study treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University Hospital
Stony Brook, New York, 11794
Andrea Gowie
Adam Singer, MD
About this study
Official title: Comparing Intravenous Famotidine and Oral Antacids in the Treatment of Dyspepsia in the Emergency Department
The aim of this study is to compare intravenous famotidine, an H2 receptor antagonist, and Maalox/ Mylanta, an oral antacid, in treatment of dyspepsia in the emergency department. The goal of this study is to reduce patients' pain based on the verbal numerical pain scale. The anticipated outcome is for pain levels in both groups to decrease. It is expected that antacids will improve symptoms more quickly and to a greater degree within an hour of taking medication based on the results of similar studies.
Read the detailed description
This study will be conducted in the Emergency Department at Stony Brook University Hospital. Investigators intend to enroll approximately 80 patients who present to the emergency department with dyspepsia symptoms. The patients will be randomized to one of two groups: one group will receive 20 mg of intravenous famotidine and the other will receive 30 ml of oral Maalox/ Mylanta. The verbal numeric pain score (VNP) will be used to measure pain at 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after administration of the study drug. Pain severity assessments will be performed by an investigator blinded to study treatment. Data will also be collected regarding demographic, clinical information, patient satisfaction and the need for rescue medications in each of the two study groups at the end of the 60-minute study period. At the end of the study period, the patients may be treated with additional analgesia at the discretion of their ED provider.
- Conditions
- Dyspepsia, GERD, Acid Reflux
- Being tested
- Intravenous Famotidine, Oral Maalox/ Mylanta
- Keywords
- dyspepsia, GERD, Acid Reflux, H2 receptor antagonist, antacid, Maalox, Mylanta, Famotidine
- Medical subject headings
- Dyspepsia, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous FamotidineDrug
Also called H2 Receptor Antagonist
Patients in this group will receive 20mg IV Famotidine.
Oral Maalox/ MylantaDrug
Also called Antacid
Patients in this group will receive 30 ml Maalox/ Mylanta.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Famotidine | Active comparator | Patients in this group will receive 20 mg of intravenous famotidine. Receives: Drug: Intravenous Famotidine |
| Oral Maalox | Active comparator | Patients in the group will receive 30 ml of oral Maalox/ Mylanta. Receives: Drug: Oral Maalox/ Mylanta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Numerical Pain Score
Patients will be asked to rate their pain on a scale of 0 to 10 with 0 indicating no pain and 10 indicating the worst pain imaginable every 15 minutes for 60 minutes.
Measured: at 1 hour
Secondary outcomes (2)
Need for Rescue Medications
Investigators will assess frequency of need for rescue medications between groups.
Measured: at 1 hour
Satisfaction with Assigned Medication
Investigators will gather data regarding patient satisfaction with their assigned treatment using a 5 item likert scale from very dissatisfied (1), dissatisfied (2) neither satisfied nor dissatisfied (3), satisfied (4) and very satisfied (5). The outcome will be measured as the percentages of patients choosing very satisfied or satisfied with their assigned medications.
Measured: at 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start9 Nov 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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.
- 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
- Parallel groups
- Model description
- Subjects are divided into two groups and randomly assigned to receive either study drug.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Singer, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241183
- Sponsor's protocol ID
- IRB2023-00188
- Status last verified
- Jun 2026
- First submitted
- 16 Jan 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Intravenous Famotidine and Oral Antacids in the Treatment of Dyspepsia in the Emergency Department
- ClinicalTrials.gov ID
- NCT06241183
- Acronym / sponsor ID
- IRB2023-00188
- Conditions
- Dyspepsia, GERD, Acid Reflux
- Keywords
- dyspepsia, GERD, Acid Reflux, H2 receptor antagonist, antacid, Maalox, Mylanta, Famotidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Feb 2024 (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.
The aim of this study is to compare intravenous famotidine, an H2 receptor antagonist, and Maalox/ Mylanta, an oral antacid, in treatment of dyspepsia in the emergency department. The goal of this study is to reduce patients' pain based on the verbal numerical pain scale. The anticipated outcome is for pain levels in both groups to decrease. It is expected that antacids will improve symptoms more quickly and to a greater degree within an hour of taking medication based on the results of similar studies.
Detailed description
This study will be conducted in the Emergency Department at Stony Brook University Hospital. Investigators intend to enroll approximately 80 patients who present to the emergency department with dyspepsia symptoms. The patients will be randomized to one of two groups: one group will receive 20 mg of intravenous famotidine and the other will receive 30 ml of oral Maalox/ Mylanta. The verbal numeric pain score (VNP) will be used to measure pain at 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after administration of the study drug. Pain severity assessments will be performed by an investigator blinded to study treatment. Data will also be collected regarding demographic, clinical information, patient satisfaction and the need for rescue medications in each of the two study groups at the end of the 60-minute study period. At the end of the study period, the patients may be treated with additional analgesia at the discretion of their ED provider.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects are divided into two groups and randomly assigned to receive either study drug.
| Arm | Type | Receives |
|---|---|---|
| Intravenous Famotidine | Active comparator | Drug: Intravenous FamotidinePatients in this group will receive 20 mg of intravenous famotidine. |
| Oral Maalox | Active comparator | Drug: Oral Maalox/ MylantaPatients in the group will receive 30 ml of oral Maalox/ Mylanta. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject Age ≥ 18 years of age
- Patient diagnosed with dyspepsia
- Present at the ED with upper abdominal pain score of at least 3
Key exclusion criteria (8 listed)
- Hypersensitivity to an ingredient in Maalox/ Mylanta or Famotidine
- Moderate to Severe Renal Insufficiency (precaution)
- Kidney Failure
- Pregnant or Nursing
- Verbal pain score less than 3
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 |
|---|---|---|
| Intravenous FamotidineAlso: H2 Receptor AntagonistPatients in this group will receive 20mg IV Famotidine. | Drug | Intravenous Famotidine |
| Oral Maalox/ MylantaAlso: AntacidPatients in this group will receive 30 ml Maalox/ Mylanta. | Drug | Oral Maalox |
Primary outcome
Verbal Numerical Pain Score
Time frame: at 1 hour
Patients will be asked to rate their pain on a scale of 0 to 10 with 0 indicating no pain and 10 indicating the worst pain imaginable every 15 minutes for 60 minutes.
2 secondary outcomes
Need for Rescue Medications
Time frame: at 1 hour
Satisfaction with Assigned Medication
Time frame: at 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Dyspepsia
Active, not recruitingPhase 1
AutoSTEA for Adults With Functional Dyspepsia
Functional Dyspepsia
Recruiting
Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Functional Dyspepsia
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
RecruitingPhase 4
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Functional Dyspepsia, Probiotics
RecruitingPhase 2
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
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.
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 Intravenous Famotidine and Oral Maalox/ Mylanta in people with Dyspepsia and GERD, run by Stony Brook University at 1 site in United States.
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 8 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: looking for participants now, as of the sponsor's last update on 2 Jun 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam Singer, MD (6314447857, adam.singer@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Numerical Pain Score (time frame: at 1 hour). 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 2 Jun 2026.