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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

NCT ID: NCT02788123

Last Updated: 2017-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-03

Study Completion Date

2017-06-13

Brief Summary

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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

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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

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NSAID-induced Gastropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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bismuth tripotassium dicitrate and pantoprazole

Participants will receive bismuth tripotassium dicitrate (twice daily) and pantoprazole (once daily) as single tablets

Group Type EXPERIMENTAL

bismuth tripotassium dicitrate

Intervention Type DRUG

oral

pantoprazole

Intervention Type DRUG

oral

pantoprazole

Participants will receive pantoprazole (once daily) as single tablet

Group Type ACTIVE_COMPARATOR

pantoprazole

Intervention Type DRUG

oral

Interventions

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bismuth tripotassium dicitrate

oral

Intervention Type DRUG

pantoprazole

oral

Intervention Type DRUG

Other Intervention Names

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De-Nol Controloc

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Europe B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Astellas Pharma Russian affiliate

Locations

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Site RU70001

Moscow, , Russia

Site Status

Site RU70008

Saint Petersburg, , Russia

Site Status

Site RU70012

Saint Petersburg, , Russia

Site Status

Site RU70006

Volgograd, , Russia

Site Status

Site RU70013

Volgograd, , Russia

Site Status

Countries

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Russia

Other Identifiers

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3593-MA-3026-RU

Identifier Type: -

Identifier Source: org_study_id