NSAID-induced GastropathyPhase 4BiGARDNCT02788123
A Study To Assess The Efficacy And Safety Of Bismuth Tripotassium Dicitrate (De-Nol) In Combination With Pantoprazole And Pantoprazole Monotherapy In Treatment Of Subjects With Nonsteroidal Anti-Inflammatory Drugs (NSAID)-Induced Gastropathy
A Phase 4 study testing bismuth tripotassium dicitrate and pantoprazole in people with NSAID-induced Gastropathy, run by Astellas Pharma Europe B.V. at 5 sites in Russia.
Trial summary
The main purpose of this study is to evaluate clinical efficacy of bismuth tripotassium dicitrate (De-Nol) in combination with pantoprazole versus pantoprazole monotherapy in subjects with NSAID-induced gastropathy in 14±2 days of treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSAID-induced Gastropathy
- What is being tested?
- bismuth tripotassium dicitrate and pantoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 5 sitesRussia
- Study dates
- 3 Mar 2017to 13 Jun 2017
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Verified diagnosis of NSAID-induced gastropathy:
- Presence of gastric ulcer(s) and/or erosions (modified Lanza score greater than or equal to 5) based on EGDS findings at screening and;
- NSAIDs administration within 7 days before screening.
- Negative pregnancy test at screening and at Visit 1 (for females only using test strip to detect chorionic gonadotropin in urine),
- Subjects' consent to use a reliable contraception method starting from screening throughout the whole study and for 1 week after its termination.
Who cannot join
- Severe complications of NSAID-gastropathy (bleedings, perforations, etc.)
- The subjects requiring concomitant therapy using the drugs specified in "Forbidden concomitant therapy".
- Ulcerative esophagitis grade C and higher according to Los-Angeles classification.
- Expressed hepatic and renal impairment.
- Any esophageal and gastric surgery that can make subject ineligible for study participation.
- Abuse of psychoactive substances including alcohol which may interfere with the subject's participation and fulfillment of all the protocol requirements.
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- Participation in other clinical studies within 30 days prior to Screening Visit.
- Administration of bismuth products less than 2 months prior to screening.
- Administration of PPIs or histamine Н2-receptor antagonists less than 2 weeks prior to screening.
- Hypersensitivity to any of the components of the study drugs or contraindications to them.
- Pregnancy and lactation.
- Inability to perform follow-up EGDS after 2 and/or 4 weeks of the study.
- Any condition or concomitant disease and laboratory parameter abnormalities which renders the subject ineligible for the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Russia5 sites
Site RU70001
Moscow
Site RU70008
Saint Petersburg
Site RU70012
Saint Petersburg
Site RU70006
Volgograd
Site RU70013
Volgograd
About this study
Official title: Phase IV, Multicenter, Open Label, Randomized Study in Parallel Groups To Assess The Efficacy And Safety Of Bismuth Tripotassium Dicitrate (De-Nol®) In Combination With Pantoprazole And Pantoprazole Monotherapy In Treatment Of Patients With NSAID Induced Gastropathy
The main purpose of this study is to evaluate clinical efficacy of bismuth tripotassium dicitrate (De-Nol) in combination with pantoprazole versus pantoprazole monotherapy in subjects with NSAID-induced gastropathy in 14±2 days of treatment.
Read the detailed description
This study has a screening period (up to 3±2 days duration). Randomization will be held in each stratum (H. pylori-positive and H. pylori-negative) on the Visit 1. Treatment period will consist of 2 visits: Visit 2 (up to 14±2 days after Visit 1) in subjects with completely healed ulcer(s) and erosions after control esophagogastroduodenoscopy (EGDS) and Visit 3 (up to 28±2 days after Visit 1) in subjects with not healed ulcers and erosions after control EGDS on Visit 2. The period of follow-up safety assessments will last 1 week after the end of the study treatment
- Conditions
- NSAID-induced Gastropathy
- Being tested
- bismuth tripotassium dicitrate, pantoprazole
- Keywords
- De-Nol, NSAID-induced gastropathy, Pantoprazole, Bismuth tripotassium dicitrate, Russia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bismuth tripotassium dicitrateDrug
Also called De-Nol
oral
pantoprazoleDrug
Also called Controloc
oral
| Study group | Role | What they receive |
|---|---|---|
| bismuth tripotassium dicitrate and pantoprazole | Experimental | Participants will receive bismuth tripotassium dicitrate (twice daily) and pantoprazole (once daily) as single tablets Receives: Drug: bismuth tripotassium dicitrate; Drug: pantoprazole |
| pantoprazole | Active comparator | Participants will receive pantoprazole (once daily) as single tablet Receives: Drug: pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects in each group reaching complete healing of NSAID-induced gastropathy at week 2 of therapy
Modified Lanza score 0-2 (inclusively) shall be considered as healing. The modified Lanza scale is utilized to grade the degree of gastritis
Measured: Week 2
Secondary outcomes (25)
Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-negative subjects in each treatment group at week 2
Modified Lanza scale 0-2 scores (inclusively) shall be considered as complete healing
Measured: Week 2
Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-positive subjects in each treatment group at week 2
Modified Lanza scale 0-2 scores (inclusively) shall be considered as complete healing
Measured: Week 2
Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-negative subjects in each treatment group at week 4
Subjects reached complete healing of NSAID-induced gastric ulcers and erosions by Visit 2 shall also be analyzed
Measured: Week 4
Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-positive subjects in each treatment group at week 4
Subjects reached complete healing of NSAID-induced gastric ulcers and erosions by Visit 2 shall also be analyzed
Measured: Week 4
Proportion of subjects reaching complete healing of NSAID-induced gastropathy in subjects with NSAID-induced gastropathy with modified Lanza scale greater than or equal to 5 and <7 at screening in each treatment group at week 2
The modified Lanza scale is utilized to grade the degree of gastritis. Modified Lanza scale 0-2 scores (inclusively) shall be considered as complete healing
Measured: Week 2
Proportion of subjects reaching complete healing of NSAID-induced gastropathy in subjects with NSAID-induced gastropathy with modified Lanza scale =7 at screening in each treatment group at week 2
The modified Lanza scale is utilized to grade the degree of gastritis. Modified Lanza scale 0-2 scores (inclusively) shall be considered as complete healing
Measured: Week 2
Proportion of subjects reaching complete healing of NSAID-induced gastropathy in subjects with NSAID-induced gastropathy with modified Lanza scale greater than or equal to 5 and <7 at screening in each treatment group at week 4
The modified Lanza scale is utilized to grade the degree of gastritis. Modified Lanza scale 0-2 scores (inclusively) shall be considered as complete healing. Subjects reached complete healing of NSAID-induced gastric ulcers and erosions by Visit 2 shall also be analyzed
Measured: Week 4
Proportion of subjects reaching complete healing of NSAID-induced gastropathy in subjects with NSAID-induced gastropathy with modified Lanza scale =7 at screening in each treatment group at week 4
The modified Lanza scale is utilized to grade the degree of gastritis. Modified Lanza scale 0-2 scores (inclusively) shall be considered as complete healing. Subjects reached complete healing of NSAID-induced gastric ulcers and erosions by Visit 2 shall also be analyzed
Measured: Week 4
Proportion of subjects reaching complete healing of NSAID-induced gastropathy in each treatment group at week 4
Subjects reached complete healing of NSAID-induced gastric ulcers and erosions by Visit 2 shall also be analyzed
Measured: Week 4
Changes in modified Lanza as compared to visit 1 (baseline) in H.pylori-negative subjects in each treatment group
The modified Lanza scale is utilized to grade the degree of gastritis
Measured: Baseline, week 2 and week 4
Changes in modified Lanza as compared to visit 1 (baseline) in H.pylori-positive subjects in each treatment group
The modified Lanza scale is utilized to grade the degree of gastritis
Measured: Baseline, week 2 and week 4
Changes in modified Lanza as compared to Visit 1 (baseline) in subjects with NSAID-induced gastropathy with modified Lanza scale greater than or equal to 5 and <7 at screening in each treatment group
The modified Lanza scale is utilized to grade the degree of gastritis
Measured: Baseline, week 2 and week 4
Changes in modified Lanza as compared to Visit 1 (baseline) in subjects with NSAID-induced gastropathy with modified Lanza scale =7 at screening in each treatment group
The modified Lanza scale is utilized to grade the degree of gastritis
Measured: Baseline, week 2 and week 4
Changes in modified Lanza as compared to visit 1 (baseline) in each treatment group
The modified Lanza scale is utilized to grade the degree of gastritis
Measured: Baseline, week 2 and week 4
Changes in GSRS as compared to visit 1 (baseline) in H.pylori-negative subjects in each treatment group
Gastrointestinal Symptom Rating Scale (GSRS). The GSRS contains a list of questions on subject's well-being within the period from subject's last visit to study site
Measured: Baseline, week 2 and week 4
Changes in GSRS as compared to visit 1 (baseline) in H.pylori-positive subjects in each treatment group
Gastrointestinal Symptom Rating Scale (GSRS). The GSRS contains a list of questions on subject's well-being within the period from subject's last visit to study site
Measured: Baseline, week 2 and week 4
Changes in GSRS as compared to Visit 1 (baseline) in subjects with NSAID-induced gastropathy with modified Lanza scale greater than or equal to 5 and <7 at screening in each treatment group
The GSRS contains a list of questions on subject's well-being within the period from subject's last visit to study site. The modified Lanza scale is utilized to grade the degree of gastritis
Measured: Baseline, week 2 and week 4
Changes in GSRS as compared to Visit 1 (baseline) in subjects with NSAID-induced gastropathy with modified Lanza scale =7 at screening in each treatment group
The GSRS contains a list of questions on subject's well-being within the period from subject's last visit to study site. The modified Lanza scale is utilized to grade the degree of gastritis
Measured: Baseline, week 2 and week 4
Changes in GSRS as compared to visit 1 (baseline) in each treatment group
The GSRS contains a list of questions on subject's well-being within the period from subject's last visit to study site
Measured: Baseline, week 2 and week 4
Safety assessed by nature, frequency and severity of Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a subject administered a study drug or has undergone study procedures and which does not necessarily have a causal relationship with this treatment
Measured: Up to day 35
Safety assessed by nature, frequency and severity of Serious Adverse Events (SAEs)
Adverse event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important events
Measured: Up to day 35
Number of participants with Physical Exam abnormalities and/or adverse events related to treatment
Number of participants with potentially clinically significant physical exam values
Measured: Up to day 35
Number of participants with vital signs abnormalities and/or adverse events related to treatment
Number of participants with potentially clinically significant vital sign values
Measured: Up to day 35
Safety assessed through esophagogastroduodenoscopy
Amount of gastric content and its nature (mucus, bile, blood), gastric mucosa condition (edema, hyperemia, erosions, mucosal hemorrages, atrophy, hypertrophy) shall be evaluated during esophagogastroduodenoscopy
Measured: Up to day 35
Number of participants with laboratory value abnormalities and/or adverse events related to treatment
Number of participants with potentially clinically significant laboratory values
Measured: Up to day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study start3 Mar 2017
- Primary completion29 May 2017
- Study completion13 Jun 2017
Why it stopped: Internal reassessment of the medicinal product development strategy by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSAID-induced GastropathyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Astellas Pharma Russian affiliate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788123
- Sponsor's protocol ID
- 3593-MA-3026-RU
- Acronym
- BiGARD
- Status last verified
- Sep 2017
- First submitted
- 27 May 2016
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Multicenter, Open Label, Randomized Study in Parallel Groups To Assess The Efficacy And Safety Of Bismuth Tripotassium Dicitrate (De-Nol®) In Combination With Pantoprazole And Pantoprazole Monotherapy In Treatment Of Patients With NSAID Induced Gastropathy
- ClinicalTrials.gov ID
- NCT02788123
- Acronym / sponsor ID
- BiGARD / 3593-MA-3026-RU
- Conditions
- NSAID-induced Gastropathy
- Keywords
- De-Nol, NSAID-induced gastropathy, Pantoprazole, Bismuth tripotassium dicitrate, Russia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Internal reassessment of the medicinal product development strategy by Sponsor
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 29 May 2017 (actual)
- Study completion
- 13 Jun 2017 (actual)
- First posted
- 2 Jun 2016 (estimated)
- 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 main purpose of this study is to evaluate clinical efficacy of bismuth tripotassium dicitrate (De-Nol) in combination with pantoprazole versus pantoprazole monotherapy in subjects with NSAID-induced gastropathy in 14±2 days of treatment.
Detailed description
This study has a screening period (up to 3±2 days duration). Randomization will be held in each stratum (H. pylori-positive and H. pylori-negative) on the Visit 1. Treatment period will consist of 2 visits: Visit 2 (up to 14±2 days after Visit 1) in subjects with completely healed ulcer(s) and erosions after control esophagogastroduodenoscopy (EGDS) and Visit 3 (up to 28±2 days after Visit 1) in subjects with not healed ulcers and erosions after control EGDS on Visit 2. The period of follow-up safety assessments will last 1 week after the end of the study treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bismuth tripotassium dicitrate and pantoprazole | Experimental | Drug: bismuth tripotassium dicitrate, Drug: pantoprazoleParticipants will receive bismuth tripotassium dicitrate (twice daily) and pantoprazole (once daily) as single tablets |
| pantoprazole | Active comparator | Drug: pantoprazoleParticipants will receive pantoprazole (once daily) as single tablet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Verified diagnosis of NSAID-induced gastropathy:
- Negative pregnancy test at screening and at Visit 1 (for females only using test strip to detect chorionic gonadotropin in urine),
- Subjects' consent to use a reliable contraception method starting from screening throughout the whole study and for 1 week after its termination.
Key exclusion criteria (13 listed)
- Severe complications of NSAID-gastropathy (bleedings, perforations, etc.)
- The subjects requiring concomitant therapy using the drugs specified in "Forbidden concomitant therapy".
- Ulcerative esophagitis grade C and higher according to Los-Angeles classification.
- Expressed hepatic and renal impairment.
- Any esophageal and gastric surgery that can make subject ineligible for study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bismuth tripotassium dicitrateAlso: De-Noloral | Drug | bismuth tripotassium dicitrate and pantoprazole |
| pantoprazoleAlso: Controlocoral | Drug | bismuth tripotassium dicitrate and pantoprazole, pantoprazole |
Primary outcome
Proportion of subjects in each group reaching complete healing of NSAID-induced gastropathy at week 2 of therapy
Time frame: Week 2
Modified Lanza score 0-2 (inclusively) shall be considered as healing. The modified Lanza scale is utilized to grade the degree of gastritis
25 secondary outcomes
Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-negative subjects in each treatment group at week 2
Time frame: Week 2
Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-positive subjects in each treatment group at week 2
Time frame: Week 2
Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-negative subjects in each treatment group at week 4
Time frame: Week 4
Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-positive subjects in each treatment group at week 4
Time frame: Week 4
Proportion of subjects reaching complete healing of NSAID-induced gastropathy in subjects with NSAID-induced gastropathy with modified Lanza scale greater than or equal to 5 and <7 at screening in each treatment group at week 2
Time frame: Week 2
Proportion of subjects reaching complete healing of NSAID-induced gastropathy in subjects with NSAID-induced gastropathy with modified Lanza scale =7 at screening in each treatment group at week 2
Time frame: Week 2
Proportion of subjects reaching complete healing of NSAID-induced gastropathy in subjects with NSAID-induced gastropathy with modified Lanza scale greater than or equal to 5 and <7 at screening in each treatment group at week 4
Time frame: Week 4
Proportion of subjects reaching complete healing of NSAID-induced gastropathy in subjects with NSAID-induced gastropathy with modified Lanza scale =7 at screening in each treatment group at week 4
Time frame: Week 4
Proportion of subjects reaching complete healing of NSAID-induced gastropathy in each treatment group at week 4
Time frame: Week 4
Changes in modified Lanza as compared to visit 1 (baseline) in H.pylori-negative subjects in each treatment group
Time frame: Baseline, week 2 and week 4
Changes in modified Lanza as compared to visit 1 (baseline) in H.pylori-positive subjects in each treatment group
Time frame: Baseline, week 2 and week 4
Changes in modified Lanza as compared to Visit 1 (baseline) in subjects with NSAID-induced gastropathy with modified Lanza scale greater than or equal to 5 and <7 at screening in each treatment group
Time frame: Baseline, week 2 and week 4
Changes in modified Lanza as compared to Visit 1 (baseline) in subjects with NSAID-induced gastropathy with modified Lanza scale =7 at screening in each treatment group
Time frame: Baseline, week 2 and week 4
Changes in modified Lanza as compared to visit 1 (baseline) in each treatment group
Time frame: Baseline, week 2 and week 4
Changes in GSRS as compared to visit 1 (baseline) in H.pylori-negative subjects in each treatment group
Time frame: Baseline, week 2 and week 4
Changes in GSRS as compared to visit 1 (baseline) in H.pylori-positive subjects in each treatment group
Time frame: Baseline, week 2 and week 4
Changes in GSRS as compared to Visit 1 (baseline) in subjects with NSAID-induced gastropathy with modified Lanza scale greater than or equal to 5 and <7 at screening in each treatment group
Time frame: Baseline, week 2 and week 4
Changes in GSRS as compared to Visit 1 (baseline) in subjects with NSAID-induced gastropathy with modified Lanza scale =7 at screening in each treatment group
Time frame: Baseline, week 2 and week 4
Changes in GSRS as compared to visit 1 (baseline) in each treatment group
Time frame: Baseline, week 2 and week 4
Safety assessed by nature, frequency and severity of Adverse Events (AEs)
Time frame: Up to day 35
Safety assessed by nature, frequency and severity of Serious Adverse Events (SAEs)
Time frame: Up to day 35
Number of participants with Physical Exam abnormalities and/or adverse events related to treatment
Time frame: Up to day 35
Number of participants with vital signs abnormalities and/or adverse events related to treatment
Time frame: Up to day 35
Safety assessed through esophagogastroduodenoscopy
Time frame: Up to day 35
Number of participants with laboratory value abnormalities and/or adverse events related to treatment
Time frame: Up to day 35
Results and safety
The study was stopped early (reason given: Internal reassessment of the medicinal product development strategy by Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
- Individual participant dataSharing planned: Undecided
Related trials for NSAID-induced Gastropathy
Not yet recruitingObservational study
Fexuclue for Prevention of NSAIDs-Induced Peptic Ulcer in Real-World Practice
Peptic Ulcer, NSAID-Induced Peptic Ulcer
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 Monitor study director
Astellas Pharma Russian affiliate
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bismuth tripotassium dicitrate and pantoprazole in people with NSAID-induced Gastropathy, run by Astellas Pharma Europe B.V. at 5 sites in Russia.
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 5 inclusion and 13 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: stopped early, as of the sponsor's last update on 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Internal reassessment of the medicinal product development strategy by Sponsor). Results are not available in the source record.
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?
Proportion of subjects in each group reaching complete healing of NSAID-induced gastropathy at week 2 of therapy (time frame: Week 2). 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 21 Sep 2017.