A Phase 4 interventional study of Talcid (Hydrotalcite, BAY4516H) and Famotidine in Heartburn, sponsored by Bayer. Completed at 5 sites in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-12-25.
Sponsored by Bayer · Phase 4, Interventional, and Treatment
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.
99 studies on the registry are indexed under Heartburn; 10 are open to participants now.
This study's enrollment of 559 is above the median of 100 across 80 interventional studies indexed under Heartburn.
Browse Heartburn studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Famotidine, 3rd heartburn episode Placebo
Drug: Talcid (Hydrotalcite, BAY4516H) · Drug: Famotidine · Drug: Placebo
1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Placebo, 3rd heartburn episode Famotidine
Drug: Talcid (Hydrotalcite, BAY4516H) · Drug: Famotidine · Drug: Placebo
1st heartburn episode Intervention Famotidine, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Placebo
Drug: Talcid (Hydrotalcite, BAY4516H) · Drug: Famotidine · Drug: Placebo
1st heartburn episode Intervention Famotidine, 2nd heartburn episode Placebo, 3rd heartburn episode Hydrotalcid
Drug: Talcid (Hydrotalcite, BAY4516H) · Drug: Famotidine · Drug: Placebo
1st heartburn episode Intervention Placebo, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Famotidine
Drug: Talcid (Hydrotalcite, BAY4516H) · Drug: Famotidine · Drug: Placebo
1st heartburn episode Intervention Placebo, 2nd heartburn episode Famotidine, 3rd heartburn episode Hydrotalcid
Drug: Talcid (Hydrotalcite, BAY4516H) · Drug: Famotidine · Drug: Placebo
2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine
2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg
2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine
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.
Time frame: up to 60 minutes
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.
Time frame: 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.
Time frame: up to 3 h
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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