A Phase 4 interventional study of Lansoprazole/Domperidone and Lansoprazole in GERD, Cardiac Event and Safety Issues, sponsored by Neutec Ar-Ge San ve Tic A.Ş. Withdrawn at 16 sites in Turkey. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-01-05.
Sponsored by Neutec Ar-Ge San ve Tic A.Ş · Phase 4, Interventional, and Screening
The aim of current study is to compare safety and efficacy of lansoprazole/domperidone 30/30 mg sustained release capsules (brand name: Duolans) and lansoprazole 30 mg micropellet capsules (brand name: Lasotab) in GERD patients in terms of cardiac safety.
Exclusion Criteria:
Patient will be administered lansoprazole/domperidone 30/30 mg capsules (brand name: Duolans) half an hour before breakfast for eight weeks according to randomisation scheme.
Combination Product: Lansoprazole/Domperidone
Patient will be administered lansoprazole 30 mg capsules (brand name: Lasotab) half an hour before breakfast for eight weeks according to randomisation scheme.
Drug: Lansoprazole
Experimental
Also known as: Duolans
Active comparator
Also known as: Lasotab
Change in QT and corrected QT (QTc) interval compared to baseline
Time frame: 8 weeks
Change in upper gastrointestinal symptom severity index compared to baseline.
Time frame: 8 weeks
Plan to share: No
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This study is withdrawn, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Neutec Ar-Ge San ve Tic A.Ş