HeartburnPhase 4NCT01928888
Placebo Controlled Phase IV Study to Compare the Efficacy and Safety of a Single Dose of Oral Talcid, a Single Dose of Oral Famotidine and a Single Dose of Placebo in Patients With Acute Heartburn Episodes
A Phase 4 study testing Talcid (Hydrotalcite, BAY4516H) and Famotidine in people with Heartburn, run by Bayer at 5 sites in Germany.
Trial summary
The purpose of this study is to compare the efficacy and safety of a single oral administration of 1000 mg Talcid® (study medication), a single oral administration of 10 mg famotidine and a single oral administration of placebo (comparator without an active substance) in treating the symptoms of acute heartburn… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heartburn
- What is being tested?
- Talcid (Hydrotalcite, BAY4516H) and Famotidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 559 participants
- Where
- 5 sitesGermany
- Study dates
- May 2003to Feb 2004
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between the age of 18 to 65 years
- A minimum of 6 months history of heartburn
- History of relief of heartburn episodes after self-medication (OTC use) within at least 2 hours
- Occurrence of heartburn episodes at least twice a week during the previous two months
- Severity of heartburn episodes at least 5 on an 11-category heartburn severity scale
Who cannot join
- History of 'alarming symptoms' e.g. weight loss, vomiting, dysphagia, anemia, hematemesis or melaena
- History of gastric ulcer or gastroesophageal reflux disease requiring regular or intermittent therapy with H2-antagonists or proton pump inhibitors within the previous year
- History of significant gastrointestinal hemorrhage or gastrointestinal surgery
- Gastrointestinal odynophagia (pain during swallowing)
- History or concurrent known duodenitis, pyloric dysfunction with alkaline reflux, motility disturbances, Heliobacter pylori gastritis, or cholelithiasis
- Pregnant or lactating women, or sexually active women of child-bearing potential unless using effective contraception
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Study site
Ask Central Contact
Study site
Berlin, State of Berlin, 10437
Study site
Dresden, Saxony, 01307
Study site
Frankfurt am Main, Hesse, 60596
Study site
Leipzig, Saxony, 04107
About this study
Official title: A Randomized, Double-blind, Three-fold Cross-over, Multi-center Study to Compare the Efficacy and Safety of a Single Dose of Oral Talcid (1000 mg Hydrotalcite), a Single Dose of Oral Famotidine 10 mg, and a Single Dose of Placebo in Patients With Acute Heartburn Episodes.
The purpose of this study is to compare the efficacy and safety of a single oral administration of 1000 mg Talcid® (study medication), a single oral administration of 10 mg famotidine and a single oral administration of placebo (comparator without an active substance) in treating the symptoms of acute heartburn episodes. The study is designed to collect more efficacy data on Talcid® in patients using self-medication to relief the symptoms of acute heartburn.
- Conditions
- Heartburn
- Being tested
- Talcid (Hydrotalcite, BAY4516H), Famotidine, Placebo
- Keywords
- Acute heartburn episodes
- Medical subject headings
- Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talcid (Hydrotalcite, BAY4516H)Drug
2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine
FamotidineDrug
2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg
PlaceboDrug
2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine
| Study group | Role | What they receive |
|---|---|---|
| Arm HFP | Experimental | 1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Famotidine, 3rd heartburn episode Placebo Receives: Drug: Talcid (Hydrotalcite, BAY4516H); Drug: Famotidine; Drug: Placebo |
| Arm HPF | Experimental | 1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Placebo, 3rd heartburn episode Famotidine Receives: Drug: Talcid (Hydrotalcite, BAY4516H); Drug: Famotidine; Drug: Placebo |
| Arm FHP | Experimental | 1st heartburn episode Intervention Famotidine, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Placebo Receives: Drug: Talcid (Hydrotalcite, BAY4516H); Drug: Famotidine; Drug: Placebo |
| Arm FPH | Experimental | 1st heartburn episode Intervention Famotidine, 2nd heartburn episode Placebo, 3rd heartburn episode Hydrotalcid Receives: Drug: Talcid (Hydrotalcite, BAY4516H); Drug: Famotidine; Drug: Placebo |
| Arm PHF | Experimental | 1st heartburn episode Intervention Placebo, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Famotidine Receives: Drug: Talcid (Hydrotalcite, BAY4516H); Drug: Famotidine; Drug: Placebo |
| Arm PFH | Experimental | 1st heartburn episode Intervention Placebo, 2nd heartburn episode Famotidine, 3rd heartburn episode Hydrotalcid Receives: Drug: Talcid (Hydrotalcite, BAY4516H); Drug: Famotidine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total heartburn relief over 0-60 min
The total heartburn relief is claculated as sum of the heartburn relief scores based on a 5-point verbal rating scale.
Measured: up to 60 minutes
Secondary outcomes (2)
Total heartburn relief 0-30 min after comparison hydrotalcite vs. placebo and vs famotidine
The total heartburn relief is claculated as sum of the heartburn relief scores based on a 5-point verbal rating scale.
Measured: up to 30 min
Total heartburn relief 0-3 h after comparison hydrotalcite vs. placebo and vs famotidine
The total heartburn relief is claculated as sum of the heartburn relief scores based on a 5-point verbal rating scale.
Measured: up to 3 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startMay 2003
- Primary completionFeb 2004
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeartburnStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 559 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928888
- Sponsor's protocol ID
- 11201
- Status last verified
- Dec 2014
- First submitted
- 20 Aug 2013
- Last updated
- 25 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Three-fold Cross-over, Multi-center Study to Compare the Efficacy and Safety of a Single Dose of Oral Talcid (1000 mg Hydrotalcite), a Single Dose of Oral Famotidine 10 mg, and a Single Dose of Placebo in Patients With Acute Heartburn Episodes.
- ClinicalTrials.gov ID
- NCT01928888
- Acronym / sponsor ID
- 11201
- Conditions
- Heartburn
- Keywords
- Acute heartburn episodes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 559 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 27 Aug 2013 (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.
The purpose of this study is to compare the efficacy and safety of a single oral administration of 1000 mg Talcid® (study medication), a single oral administration of 10 mg famotidine and a single oral administration of placebo (comparator without an active substance) in treating the symptoms of acute heartburn episodes. The study is designed to collect more efficacy data on Talcid® in patients using self-medication to relief the symptoms of acute heartburn.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm HFP | Experimental | Drug: Talcid (Hydrotalcite, BAY4516H), Drug: Famotidine, Drug: Placebo1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Famotidine, 3rd heartburn episode Placebo |
| Arm HPF | Experimental | Drug: Talcid (Hydrotalcite, BAY4516H), Drug: Famotidine, Drug: Placebo1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Placebo, 3rd heartburn episode Famotidine |
| Arm FHP | Experimental | Drug: Talcid (Hydrotalcite, BAY4516H), Drug: Famotidine, Drug: Placebo1st heartburn episode Intervention Famotidine, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Placebo |
| Arm FPH | Experimental | Drug: Talcid (Hydrotalcite, BAY4516H), Drug: Famotidine, Drug: Placebo1st heartburn episode Intervention Famotidine, 2nd heartburn episode Placebo, 3rd heartburn episode Hydrotalcid |
| Arm PHF | Experimental | Drug: Talcid (Hydrotalcite, BAY4516H), Drug: Famotidine, Drug: Placebo1st heartburn episode Intervention Placebo, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Famotidine |
| Arm PFH | Experimental | Drug: Talcid (Hydrotalcite, BAY4516H), Drug: Famotidine, Drug: Placebo1st heartburn episode Intervention Placebo, 2nd heartburn episode Famotidine, 3rd heartburn episode Hydrotalcid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female between the age of 18 to 65 years
- A minimum of 6 months history of heartburn
- History of relief of heartburn episodes after self-medication (OTC use) within at least 2 hours
- Occurrence of heartburn episodes at least twice a week during the previous two months
- Severity of heartburn episodes at least 5 on an 11-category heartburn severity scale
Key exclusion criteria (6 listed)
- History of 'alarming symptoms' e.g. weight loss, vomiting, dysphagia, anemia, hematemesis or melaena
- History of gastric ulcer or gastroesophageal reflux disease requiring regular or intermittent therapy with H2-antagonists or proton pump inhibitors within the previous year
- History of significant gastrointestinal hemorrhage or gastrointestinal surgery
- Gastrointestinal odynophagia (pain during swallowing)
- History or concurrent known duodenitis, pyloric dysfunction with alkaline reflux, motility disturbances, Heliobacter pylori gastritis, or cholelithiasis
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 |
|---|---|---|
| Talcid (Hydrotalcite, BAY4516H)2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine | Drug | Arm FHP, Arm FPH, Arm HFP, Arm HPF, Arm PFH, Arm PHF |
| Famotidine2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg | Drug | Arm FHP, Arm FPH, Arm HFP, Arm HPF, Arm PFH, Arm PHF |
| Placebo2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine | Drug | Arm FHP, Arm FPH, Arm HFP, Arm HPF, Arm PFH, Arm PHF |
Primary outcome
Total heartburn relief over 0-60 min
Time frame: up to 60 minutes
The total heartburn relief is claculated as sum of the heartburn relief scores based on a 5-point verbal rating scale.
2 secondary outcomes
Total heartburn relief 0-30 min after comparison hydrotalcite vs. placebo and vs famotidine
Time frame: up to 30 min
Total heartburn relief 0-3 h after comparison hydrotalcite vs. placebo and vs famotidine
Time frame: up to 3 h
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 25 Dec 2014.
Related trials for Heartburn
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
Symptomatic Non-erosive Gastroesophageal Reflux Disease
Active, not recruitingPhase 3
Domperidone in Treating Patients With Gastrointestinal Disorders
Digestive System Disorder, Dyspepsia
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn
Enrolling by invitationObservational study
The Johns Hopkins Heartburn Center Registry
Gastroesophageal Reflux Disease, Barrett Esophagus
Not yet recruiting
Antireflux Surgery Without Preoperative Esophageal Manometry
GERD, Hiatal Hernia
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.
Bayer Study Director study director
Bayer
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Talcid (Hydrotalcite, BAY4516H) and Famotidine in people with Heartburn, run by Bayer at 5 sites in Germany.
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 5 inclusion and 6 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 25 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. 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?
Total heartburn relief over 0-60 min (time frame: up to 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 25 Dec 2014.