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

• Status: Terminated
• Trial end date: 2017-06-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Europe B.V.
• Treatments: Anti-Inflammatory Agents, Non-Steroidal; Bismuth; Bismuth tripotassium dicitrate; Pantoprazole

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.