A Study of Dexlansoprazole Modified Release (MR) in Gastroesophageal Reflux Disease (GERD) Participants in the Russian Federation

NCT ID: NCT04311541

Last Updated: 2020-04-14

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-15
• Study Completion Date: 2022-01-31

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.

Conditions

Gastroesophageal Reflux Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Dexlansoprazole

Participants diagnosed with GERD and initiated treatment with dexlansoprazole MR therapy will be observed prospectively at 150 sites in Russian federation for a period of 2 months.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

Other Identifiers

U1111-1247-2413

Identifier Type: REGISTRY

Identifier Source: secondary_id

MACS-2019-102840

Identifier Type: -

Identifier Source: org_study_id