Clinical trial NCT04311541: A Study of Dexlansoprazole Modified Release (MR) in Gastroesophageal Reflux Disease (GERD) Participants in the Russian Federation
Official title: National, Multicentre, Observational, Non-Interventional Prospective Study of Dexlansoprazole MR in GERD Patients in the Russian Federation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gastroesophageal Reflux Disease
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2020-03-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in Russian federation diagnosed with GERD will be enrolled in this study.

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 enroll approximately 1500 participants. Due to non-interventional design of the study, the decision about GERD treatment strategy for the participant is taken by attending treating physician. All participants will be enrolled in one observational group: dexlansoprazole.

Prospective data will be collected for a period of 2 months. The frequency of the visits will be assigned by each physician according to their routine practice.

The multi-center trial will be conducted in Russia. The overall duration of study will be approximately 2 months.

Eligibility criteria: Inclusion Criteria:

1. Male and female participants 18 or older years of age by the time of enrolment.
2. 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.
3. Participants diagnosed with GERD less than (\<) 3 years prior to study entry, with or without treatment with other GERD medications.
4. 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.
5. The physician decides to prescribe Dexilant:

   * as monotherapy or
   * as a part of combined therapy
6. Written informed consent, signed before the participation in the study begins.

Exclusion Criteria:

1. Contraindications for proton-pump inhibitors (PPIs) of respective approved local packaging leaflets.
2. Existence of upper gastrointestinal bleeding.
3. History of surgery on esophagus, stomach or duodenum.
4. 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.
5. Malignant disease of any kind any system or organ within 5 years, except completely recovered skin cancer.
6. Needs in antibiotics due to severe infection.
7. Alanine transaminase (ALT) or Aspartate aminotransferase (AST) \>=Upper limit of normal range\*3.
8. Current, previous (within the last one year) or planned (for the next one year) participation in interventional clinical trial.
9. Presenting of mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
10. Any other condition, which on the opinion of the investigator may interfere the participant's participation in the study.

Primary outcomes:
measure: Change From Baseline (Visit 1) in GERDq Score on Dexilant Treatment Among GERD Participants at Month 1 (Visit 3)
timeFrame: Baseline (Visit 1), Month 1 (Visit 3)
Secondary outcomes:
measure: Change From Baseline (Visit 1) in Each of the 6 Questions in GERDq on Dexilant Treatment Among the GERD Participants at Months 1 (Visit 3) and 2 (Visit 4)
timeFrame: Baseline (Visit 1), Month 1 (Visit 3) and Month 2 (Visit 4)
measure: Change From Baseline (Visit 1) in GERDq Score on Dexilant Treatment Among GERD Participants at Months 1 (Visit 3) and 2 (Visit 4)
timeFrame: Baseline (Visit 1), Month 1 (Visit 3) and Month 2 (Visit 4)
measure: Changes From Baseline (Visit 1) in Daytime Severity GERD Symptoms by Likert Scale on Dexilant Treatment Among GERD Participants at Months 1 (Visit 3) and 2 (Visit 4)
timeFrame: Baseline (Visit 1), Month 1 (Visit 3) and Month 2 (Visit 4)
measure: Changes From Baseline (Visit 1) in Nocturnal Severity GERD Symptoms by Likert Scale on Dexilant Treatment Among GERD Participants at Months 1 (Visit 3) and 2 (Visit 4)
timeFrame: Baseline (Visit 1), Month 1 (Visit 3) and Month 2 (Visit 4)
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: