Gastroesophageal Reflux DiseaseINTEGRONCT04311541
A Study of Dexlansoprazole Modified Release (MR) in Gastroesophageal Reflux Disease (GERD) Participants in the Russian Federation
An observational study of Gastroesophageal Reflux Disease, run by Takeda.
Trial summary
The primary purpose of the study is to evaluate effect of Dexilant treatment among GERD participants in the Russian Federation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2020to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants in Russian federation diagnosed with GERD will be enrolled in this study.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
About this study
Official title: 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.
Read the 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
- Keywords
- Drug Therapy
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline (Visit 1), Month 1 (Visit 3) and Month 2 (Visit 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start15 Mar 2020 (estimated)
- Primary completion15 Jun 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Why it stopped: Business Decision; No Safety Or Efficacy Concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311541
- Sponsor's protocol ID
- MACS-2019-102840
- Other IDs
- U1111-1247-2413
- Acronym
- INTEGRO
- Status last verified
- Apr 2020
- First submitted
- 13 Mar 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Multicentre, Observational, Non-Interventional Prospective Study of Dexlansoprazole MR in GERD Patients in the Russian Federation
- ClinicalTrials.gov ID
- NCT04311541
- Acronym / sponsor ID
- INTEGRO / MACS-2019-102840
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Business Decision; No Safety Or Efficacy Concerns
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2020 (estimated)
- Primary completion
- 15 Jun 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in Russian federation diagnosed with GERD will be enrolled in this study.
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
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)
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)
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)
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease, run by Takeda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.