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

NCT02788123 | Terminated Phase 4

• 1 other identifier: 3593-MA-3026-RU
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 5

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.

Conditions

NSAID-induced Gastropathy

Keywords

De-Nol; NSAID-induced gastropathy; Pantoprazole; Bismuth tripotassium dicitrate; Russia

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Week 2

• Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-positive subjects in each treatment group at week 2

  Week 2

• Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-negative subjects in each treatment group at week 4

  Week 4

• Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-positive subjects in each treatment group at week 4

  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

  Week 2

Study Arms (2)

bismuth tripotassium dicitrate and pantoprazole

EXPERIMENTAL

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

Drug: bismuth tripotassium dicitrate; Drug: pantoprazole

pantoprazole

ACTIVE COMPARATOR

Participants will receive pantoprazole (once daily) as single tablet

Drug: pantoprazole

Interventions

bismuth tripotassium dicitrate DRUG

oral

Also known as: De-Nol

bismuth tripotassium dicitrate and pantoprazole

pantoprazole DRUG

oral

Also known as: Controloc

bismuth tripotassium dicitrate and pantoprazole; pantoprazole

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead

Study Sites (5)

Site RU70001

Moscow, Russia

Location

Site RU70008

Saint Petersburg, Russia

Location

Site RU70012

Saint Petersburg, Russia

Location

Site RU70006

Volgograd, Russia

Location

Site RU70013

Volgograd, Russia

Location

MeSH Terms

Interventions

bismuth tripotassium dicitrate; Pantoprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Medical Monitor

  Astellas Pharma Russian affiliate

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 2, 2016
• Study Start: March 3, 2017
• Primary Completion: May 29, 2017
• Study Completion: June 13, 2017
• Last Updated: September 21, 2017

Record last verified: 2017-09

Locations

RU (5)