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 (BiGARD)

Astellas

Status and phase: Terminated; Phase 4

Conditions: NSAID-induced Gastropathy

Treatments: Drug: pantoprazole; Drug: bismuth tripotassium dicitrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02788123

3593-MA-3026-RU

Details and patient eligibility

About

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.

Full 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

Enrollment: 9 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

bismuth tripotassium dicitrate and pantoprazole

Experimental group

Description:

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

Treatment:

Drug: bismuth tripotassium dicitrate

Drug: pantoprazole

pantoprazole

Active Comparator group

Description:

Participants will receive pantoprazole (once daily) as single tablet

Treatment:

Drug: pantoprazole