Condition: GERD (Gastroesophageal Reflux Disease) · Sponsor: Cinclus Pharma Holding AB
The goal of this clinical trial is to find out how well linaprazan glurate can heal erosive esophagitis (EE) caused by gastroesophageal reflux disease (GERD), compared to lansoprazole, a commonly used medication. Researchers will also evaluate whether linaprazan glurate: * Reduces heartburn symptoms more effectively than lansoprazole * Is safe and well tolerated, based on physical exams, blood tests, and vital signs (heart rate, blood pressure, temperature, and breathing rate) * Causes any side effects during treatment * Has different effects depending on how much of the drug is in the blood * Works differently depending on participants' genes Participants must be between 18 to 80 years old and have EE due to GERD confirmed by an endoscopy. Participants cannot join if they have an active Helicobacter pylori (HP) infection or were treated for HP in the past 6 weeks or have taken antibiotics or bismuth-containing drugs in the past 6 weeks. The study is a randomized, double-blind, active comparator-controlled trial lasting up to 4 months. Randomized means that participants are assigned by chance (like flipping a coin) to one of the treatment groups and double-blind means neither the participants nor the study team will know which treatment is given. Participants will be placed into one of three groups (about 167 people in each group): * Linaprazan glurate 50 mg twice a day * Linaprazan glurate 50 mg once a day * Lansoprazole 30 mg once a day Everyone will take 2 tablets and…
This description comes directly from the study's public registry record.
Rikard Reneland, MD, PhD · +46 70 300 40 88 · rikard.reneland@cincluspharma.com
Kajsa Larsson, MD, PhD · +46 70 675 01 28 · kajsa.larsson@cincluspharma.com
Always discuss trial participation with your own doctor first.
| Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski - 2003" OOD | Dupnitsa, Dupnitsa, Bulgaria | Not Yet Recruiting |
| Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD | Gorna Oryahovitsa, Gorna Oryahovitsa, Bulgaria | Recruiting |
| Diagnosis - Consulting Centre 1 | Sliven, Sliven, Bulgaria | Not Yet Recruiting |
| Medical Center "Orange" | Sofia, Sofia City Province, Bulgaria | Not Yet Recruiting |
| Multiprofile Hospital for Active Treatment - "Vita" | Sofia, Sofia City Province, Bulgaria | Not Yet Recruiting |
| Diagnostic and Consulting Center Alexandrovska | Sofia, Sofia City Province, Bulgaria | Recruiting |
| Diagnostic Consultative Center - Focus-5 | Sofia, Sofia City Province, Bulgaria | Not Yet Recruiting |
| Medical Center Hera | Sofia, Sofia City Province, Bulgaria | Recruiting |
| University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL" | Sofia, Sofia City Province, Bulgaria | Not Yet Recruiting |
| University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov | Sofia, Sofia City Province, Bulgaria | Not Yet Recruiting |
| 20th Diagnostic Consultancy Center | Sofia, Sofia City Province, Bulgaria | Recruiting |
| Medical Center Hera | Kyustendil, Bulgaria | Not Yet Recruiting |
+ 63 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07037875