Status:
WITHDRAWN
A Study of Dexlansoprazole Modified Release (MR) in Gastroesophageal Reflux Disease (GERD) Participants in the Russian Federation
Lead Sponsor:
Takeda
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18+ years
Brief Summary
The primary purpose of the study is to evaluate effect of Dexilant treatment among GERD participants in the Russian Federation.
Detailed Description
This is an observational, prospective non-interventional study of participants with GERD. This study will evaluate the effect of dexlansoprazole treatment among participants with GERD. The study will...
Eligibility Criteria
Inclusion
- Male and female participants 18 or older years of age by the time of enrolment.
- Confirmed GERD diagnosis (Non-Erosive Reflux Disease (NERD) or Erosive Reflux Diseases (ERD)) on the base of typical clinical features (symptoms), upper endoscopy within last 12 months prior to inclusion and/or GERDq.
- Participants diagnosed with GERD less than (\<) 3 years prior to study entry, with or without treatment with other GERD medications.
- Participants without concomitant gastrointestinal (GI) conditions of the gastrointestinal tract and with concomitant GI conditions of the gastrointestinal tract as well as other organ systems concomitant conditions.
- The physician decides to prescribe Dexilant:
- as monotherapy or
- as a part of combined therapy
- Written informed consent, signed before the participation in the study begins.
Exclusion
- Contraindications for proton-pump inhibitors (PPIs) of respective approved local packaging leaflets.
- Existence of upper gastrointestinal bleeding.
- History of surgery on esophagus, stomach or duodenum.
- Primary esophageal motility disease, achalasia, scleroderma, esophageal / pyloric stricture, primary esophageal spasm, infectious or inflammatory bowel disease, severe malabsorption, severe chronic heart failure, serve cardiovascular disease, renal failure, chronic obstructive pulmonary disease (COPD), asthma, liver cirrhosis.
- Malignant disease of any kind any system or organ within 5 years, except completely recovered skin cancer.
- Needs in antibiotics due to severe infection.
- Alanine transaminase (ALT) or Aspartate aminotransferase (AST) \>=Upper limit of normal range\*3.
- Current, previous (within the last one year) or planned (for the next one year) participation in interventional clinical trial.
- Presenting of mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Any other condition, which on the opinion of the investigator may interfere the participant's participation in the study.
Key Trial Info
Start Date :
March 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04311541
Start Date
March 15 2020
End Date
January 31 2022
Last Update
April 14 2020
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