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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. )

Tracking Information
First Submitted Date  ICMJE May 27, 2016
First Posted Date  ICMJE June 2, 2016
Last Update Posted Date September 21, 2017
Actual Study Start Date  ICMJE March 3, 2017
Actual Primary Completion Date May 29, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 27, 2016)
  • Number of patients achieving complete healing of NSAID-induced gastropathy [ Time Frame: Week 2 ]
    Healing is defined as the absence of ulcers and erosions
  • Percentage of patients achieving complete healing of NSAID-induced gastropathy [ Time Frame: Week 2 ]
    Healing is defined as the absence of ulcers and erosions
Change History Complete list of historical versions of study NCT02788123 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2016)
  • Number of patients achieving complete healing of NSAID-induced gastropathy in H.pylori-negative patient category in each treatment group at week 2 [ Time Frame: Week 2 ]
    Healing is defined as the absence of ulcers and erosions
  • Percentage of patients achieving complete healing of NSAID-induced gastropathy in H.pylori-negative patient category in each treatment group at week 2 [ Time Frame: Week 2 ]
    Healing is defined as the absence of ulcers and erosions
  • Number of patients achieving complete healing of NSAID-induced gastropathy in H.pylori-positive patient category in each treatment group at week 2 [ Time Frame: Week 2 ]
    Healing is defined as the absence of ulcers and erosions
  • Percentage of patients achieving complete healing of NSAID-induced gastropathy in H.pylori-positive patient category in each treatment group at week 2 [ Time Frame: Week 2 ]
    Healing is defined as the absence of ulcers and erosions
  • Number of patients achieving complete healing of NSAID-induced gastropathy in H.pylori-negative patient category in each treatment group at week 4 [ Time Frame: Week 4 ]
    Healing is defined as the absence of ulcers and erosions
  • Percentage of patients achieving complete healing of NSAID-induced gastropathy in H.pylori-negative patient category in each treatment group at week 4 [ Time Frame: Week 4 ]
    Healing is defined as the absence of ulcers and erosions
  • Number of patients achieving complete healing of NSAID-induced gastropathy in H.pylori-positive patient category in each treatment group at week 4 [ Time Frame: Week 4 ]
    Healing is defined as the absence of ulcers and erosions
  • Percentage of patients achieving complete healing of NSAID-induced gastropathy in H.pylori-positive patient category in each treatment group at week 4 [ Time Frame: Week 4 ]
    Healing is defined as the absence of ulcers and erosions
  • Number of patients achieving complete healing of NSAID-induced gastropathy in each treatment group at week 4 [ Time Frame: Week 4 ]
    Healing is defined as the absence of ulcers and erosions
  • Percentage of patients achieving complete healing of NSAID-induced gastropathy in each treatment group at week 4 [ Time Frame: Week 4 ]
    Healing is defined as the absence of ulcers and erosions
  • Change in score on the modified Lanza scale compared to visit 1 (baseline) in H.pylori-negative patient category in each treatment group [ Time Frame: Baseline, week 2 and week 4 ]
    The modified Lanza scale is utilized to grade the degree of gastritis and duodenitis
  • Change in score on the modified Lanza scale compared to visit 1 (baseline) in H.pylori-positive patient category in each treatment group [ Time Frame: Baseline, week 2 and week 4 ]
    The modified Lanza scale is utilized to grade the degree of gastritis and duodenitis
  • Change in score on the modified Lanza scale of treatment 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 and duodenitis
  • Changes in gastrointestinal symptoms on scales of GSRS questionnaire compared to visit 1 (baseline) in H.pylori-negative patient category in each treatment group [ Time Frame: Baseline, week 2 and week 4 ]
    Gastrointestinal Symptom Rating Scale (GSRS)
  • Changes in gastrointestinal symptoms on scales of GSRS questionnaire compared to Visit 1 (baseline) in H.pylori-positive patient category in each treatment group [ Time Frame: Baseline, week 2 and week 4 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE NSAID-induced Gastropathy
Intervention  ICMJE
  • Drug: bismuth tripotassium dicitrate
    oral
    Other Name: De-Nol
  • Drug: pantoprazole
    oral
    Other Name: Controloc
Study Arms  ICMJE
  • Experimental: bismuth tripotassium dicitrate and pantoprazole
    Participants will receive bismuth tripotassium dicitrate (twice daily) and pantoprazole (once daily) as single tablets
    Interventions:
    • Drug: bismuth tripotassium dicitrate
    • Drug: pantoprazole
  • Active Comparator: pantoprazole
    Participants will receive pantoprazole (once daily) as single tablet
    Intervention: Drug: pantoprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 19, 2017)
9
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2016)
224
Actual Study Completion Date  ICMJE June 13, 2017
Actual Primary Completion Date May 29, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02788123
Other Study ID Numbers  ICMJE 3593-MA-3026-RU
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
Study Sponsor  ICMJE Astellas Pharma Europe B.V.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Astellas Pharma Russian affiliate
PRS Account Astellas Pharma Inc
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP