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

Phase 4TerminatedNCT02788123

Astellas Pharma Europe B.V.9 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

NSAID-induced Gastropathy

Interventions

bismuth tripotassium dicitrateDRUG

oral

pantoprazoleDRUG

oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (5)

Site RU70001

Moscow, Russia

Site RU70008

Saint Petersburg, Russia

Site RU70012

Saint Petersburg, Russia

Site RU70006

Volgograd, Russia

Site RU70013

Volgograd, Russia

Outcomes

Primary Outcomes

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

Time frame: Week 2

Secondary Outcomes

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

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

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

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

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

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

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

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

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

Data from ClinicalTrials.gov

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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

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

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

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

Time frame: 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