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

NCT04311541 | Withdrawn

• 2 other identifiers: MACS-2019-102840U1111-1247-2413
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary purpose of the study is to evaluate effect of Dexilant treatment among GERD participants in the Russian Federation.

Conditions

Gastroesophageal Reflux Disease

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (Visit 1) in GERDq Score on Dexilant Treatment Among GERD Participants at Month 1 (Visit 3)

  GERDq is a self-completed participant questionnaire that is used to assess the frequency of following symptoms: heartburn, regurgitation, stomach pain, nausea, sleep disturbance and use of additional medication due to heartburn/regurgitation. Symptom frequency will be assessed for the week passed using following answers: 0 days, 1 day, 2-3 days, and 4-7 days. Each answer will be assigned a score from 0 to 3 (heartburn, regurgitation, sleep disturbance and use of additional medication due to heartburn/regurgitation) or from 3 to 0 (stomach pain, nausea). Total score will be calculated as a sum of 6 individual scores. GERDq score was calculated as sum of these scores, giving a total score ranging from 0 to 18. When GERDq greater than or equal to (\>=)8, the participants could be symptom based diagnosed as GERD. Total score of 0 to 2 points=0 percent (%) likelihood of GERD; 3 to 7 points=50% likelihood of GERD; 8 to 10 points=79% likelihood of GERD; 11 to 18 points=89% likelihood of GERD.

  Baseline (Visit 1), Month 1 (Visit 3)

Secondary Outcomes (4)

• 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)

  Baseline (Visit 1), Month 1 (Visit 3) and Month 2 (Visit 4)

• Change From Baseline (Visit 1) in GERDq Score on Dexilant Treatment Among GERD Participants at Months 1 (Visit 3) and 2 (Visit 4)

  Baseline (Visit 1), Month 1 (Visit 3) and Month 2 (Visit 4)

• 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)

  Baseline (Visit 1), Month 1 (Visit 3) and Month 2 (Visit 4)

• 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)

  Baseline (Visit 1), Month 1 (Visit 3) and Month 2 (Visit 4)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants in Russian federation diagnosed with GERD will be enrolled in this study.

You may qualify if:

• Male and female participants 18 or older years of age by the time of enrolment.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 17, 2020
• Study Start: March 15, 2020
• Primary Completion: June 15, 2021
• Study Completion: January 31, 2022
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share