Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm HFP | Experimental | 1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Famotidine, 3rd heartburn episode Placebo |
|
| Arm HPF | Experimental | 1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Placebo, 3rd heartburn episode Famotidine |
|
| Arm FHP | Experimental | 1st heartburn episode Intervention Famotidine, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Placebo |
|
| Arm FPH | Experimental | 1st heartburn episode Intervention Famotidine, 2nd heartburn episode Placebo, 3rd heartburn episode Hydrotalcid |
|
| Arm PHF | Experimental | 1st heartburn episode Intervention Placebo, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Famotidine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talcid (Hydrotalcite, BAY4516H) | Drug | 2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 30 min |
| Total heartburn relief 0-3 h after comparison hydrotalcite vs. placebo and vs famotidine |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frankfurt am Main | Hesse | 60596 | Germany | |||
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Arm PFH | Experimental | 1st heartburn episode Intervention Placebo, 2nd heartburn episode Famotidine, 3rd heartburn episode Hydrotalcid |
|
| Famotidine | Drug | 2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg |
|
| Placebo | Drug | 2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine |
|
The total heartburn relief is claculated as sum of the heartburn relief scores based on a 5-point verbal rating scale. |
| up to 3 h |
| Dresden |
| Saxony |
| 01307 |
| Germany |
| Leipzig | Saxony | 04107 | Germany |
| Berlin | State of Berlin | 10437 | Germany |
| Ask Central Contact | Germany |
| ID | Term |
|---|---|
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C010467 | hydrotalcite |
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided