A Study To Assess The Efficacy And Safety Of Bismuth Trip... | NCT02788123

Studies
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

Sponsor

Astellas Pharma Europe B.V.

Status

Terminated

Last Update Posted

Sep 21, 2017Actual

Enrollment

9Actual

Phase

Phase 4

Conditions

NSAID-induced Gastropathy

Interventions

bismuth tripotassium dicitrate
pantoprazole

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Internal reassessment of the medicinal product development strategy by Sponsor

Expanded Access Info

Start Date

Mar 3, 2017Actual

Primary Completion Date

May 29, 2017Actual

Completion Date

Jun 13, 2017Actual

First Submitted Date

May 27, 2016

First Submission Date that Met QC Criteria

May 27, 2016

First Posted Date

Jun 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2017

Last Update Posted Date

Sep 21, 2017Actual

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
bismuth tripotassium dicitrate	Drug	oral	bismuth tripotassium dicitrate and pantoprazole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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	Week 2
Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-positive subjects in each treatment group at week 2

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Site RU70001		Moscow			Russia
Site RU70008

ID	Term
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring