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

April 13, 2020 updated by: Takeda

National, Multicentre, Observational, Non-Interventional Prospective Study of Dexlansoprazole MR in GERD Patients in the Russian Federation

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline (Visit 1) in GERDq Score on Dexilant Treatment Among GERD Participants at Month 1 (Visit 3)
Time Frame: Baseline (Visit 1), 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Baseline (Visit 1), Month 1 (Visit 3) and Month 2 (Visit 4)
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) 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)
Time Frame: Baseline (Visit 1), Month 1 (Visit 3) and Month 2 (Visit 4)
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) 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)
Time Frame: Baseline (Visit 1), Month 1 (Visit 3) and Month 2 (Visit 4)
Participants collected GERD-associated symptoms of daytime regurgitation, dysphagia, stomach pain, in daily symptom diary. Daytime episodes are defined as those that occurred after arising in the morning until retiring in the evening. The severity score was calculated was based on a 5-point Likert scale ranging from 0 (no symptom) to 4 (very severe symptom); higher scores indicated greater disease activity.
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)
Time Frame: Baseline (Visit 1), Month 1 (Visit 3) and Month 2 (Visit 4)
Participants collected GERD-associated symptoms of night time regurgitation, dysphagia, stomach pain, in daily symptom diary. Night time episodes are defined as those that occurred during the night while sleeping or trying to sleep. The severity score was calculated was based on a 5-point Likert scale ranging from 0 (no symptom) to 4 (very severe symptom); Higher scores indicated greater disease activity.
Baseline (Visit 1), Month 1 (Visit 3) and Month 2 (Visit 4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MACS-2019-102840
  • U1111-1247-2413 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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