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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 (BiGARD)

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ClinicalTrials.gov Identifier: NCT02788123
Recruitment Status : Terminated (Internal reassessment of the medicinal product development strategy by Sponsor)
First Posted : June 2, 2016
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )

Brief 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.

Condition or disease Intervention/treatment Phase
NSAID-induced Gastropathy Drug: bismuth tripotassium dicitrate Drug: pantoprazole Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 3, 2017
Actual Primary Completion Date : May 29, 2017
Actual Study Completion Date : June 13, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: bismuth tripotassium dicitrate and pantoprazole
Participants will receive bismuth tripotassium dicitrate (twice daily) and pantoprazole (once daily) as single tablets
Drug: bismuth tripotassium dicitrate
oral
Other Name: De-Nol

Drug: pantoprazole
oral
Other Name: Controloc

Active Comparator: pantoprazole
Participants will receive pantoprazole (once daily) as single tablet
Drug: pantoprazole
oral
Other Name: Controloc




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    Modified Lanza scale 0-2 scores (inclusively) shall be considered as complete healing

  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 ]
    Modified Lanza scale 0-2 scores (inclusively) shall be considered as complete healing

  3. 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 ]
    Subjects reached complete healing of NSAID-induced gastric ulcers and erosions by Visit 2 shall also be analyzed

  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 ]
    Subjects reached complete healing of NSAID-induced gastric ulcers and erosions by Visit 2 shall also be analyzed

  5. 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 ]
    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

  6. 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 ]
    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

  7. 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 ]
    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

  8. 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 ]
    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

  9. Proportion of subjects reaching complete healing of NSAID-induced gastropathy in each treatment group at week 4 [ Time Frame: Week 4 ]
    Subjects reached complete healing of NSAID-induced gastric ulcers and erosions by Visit 2 shall also be analyzed

  10. 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 ]
    The modified Lanza scale is utilized to grade the degree of gastritis

  11. 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 ]
    The modified Lanza scale is utilized to grade the degree of gastritis

  12. 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 ]
    The modified Lanza scale is utilized to grade the degree of gastritis

  13. 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 ]
    The modified Lanza scale is utilized to grade the degree of gastritis

  14. Changes in modified Lanza as compared to visit 1 (baseline) in each treatment group [ Time Frame: Baseline, week 2 and week 4 ]
    The modified Lanza scale is utilized to grade the degree of gastritis

  15. 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 ]
    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

  16. 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 ]
    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

  17. 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 ]
    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

  18. 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 ]
    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

  19. Changes in GSRS as compared to visit 1 (baseline) in each treatment group [ Time Frame: Baseline, week 2 and week 4 ]
    The GSRS contains a list of questions on subject's well-being within the period from subject's last visit to study site

  20. Safety assessed by nature, frequency and severity of Adverse Events (AEs) [ Time Frame: Up to day 35 ]
    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

  21. Safety assessed by nature, frequency and severity of Serious Adverse Events (SAEs) [ Time Frame: Up to day 35 ]
    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

  22. Number of participants with Physical Exam abnormalities and/or adverse events related to treatment [ Time Frame: Up to day 35 ]
    Number of participants with potentially clinically significant physical exam values

  23. Number of participants with vital signs abnormalities and/or adverse events related to treatment [ Time Frame: Up to day 35 ]
    Number of participants with potentially clinically significant vital sign values

  24. Safety assessed through esophagogastroduodenoscopy [ Time Frame: Up to day 35 ]
    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

  25. Number of participants with laboratory value abnormalities and/or adverse events related to treatment [ Time Frame: Up to day 35 ]
    Number of participants with potentially clinically significant laboratory values



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02788123


Locations
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Russian Federation
Site RU70001
Moscow, Russian Federation
Site RU70008
Saint-Petersburg, Russian Federation
Site RU70012
Saint-Petersburg, Russian Federation
Site RU70006
Volgograd, Russian Federation
Site RU70013
Volgograd, Russian Federation
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
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Study Director: Medical Monitor Astellas Pharma Russian affiliate

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Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT02788123     History of Changes
Other Study ID Numbers: 3593-MA-3026-RU
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
De-Nol
NSAID-induced gastropathy
Pantoprazole
Bismuth tripotassium dicitrate
Russia

Additional relevant MeSH terms:
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Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pantoprazole
Bismuth tripotassium dicitrate
Bismuth
Anti-Inflammatory Agents, Non-Steroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antacids
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Infective Agents