Clinical trial NCT02788123: 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
Official title: Phase IV, Multicenter, Open Label, Randomized Study in Parallel Groups To Assess The Efficacy And Safety Of Bismuth Tripotassium Dicitrate (De-Nol®) In Combination With Pantoprazole And Pantoprazole Monotherapy In Treatment Of Patients With NSAID Induced Gastropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: NSAID-induced Gastropathy
Keywords: De-Nol
NSAID-induced gastropathy
Pantoprazole
Bismuth tripotassium dicitrate
Russia
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2016-06-02
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Proportion of subjects in each group reaching complete healing of NSAID-induced gastropathy at week 2 of therapy
timeFrame: Week 2
Secondary outcomes:
measure: Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-negative subjects in each treatment group at week 2
timeFrame: Week 2
measure: Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-positive subjects in each treatment group at week 2
timeFrame: Week 2
measure: Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-negative subjects in each treatment group at week 4
timeFrame: Week 4
measure: Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-positive subjects in each treatment group at week 4
timeFrame: Week 4
measure: 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
timeFrame: Week 2
measure: Proportion of subjects reaching complete healing of NSAID-induced gastropathy in subjects with NSAID-induced gastropathy with modified Lanza scale =7 at screening in each treatment group at week 2
timeFrame: Week 2
measure: 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 4
timeFrame: Week 4
measure: Proportion of subjects reaching complete healing of NSAID-induced gastropathy in subjects with NSAID-induced gastropathy with modified Lanza scale =7 at screening in each treatment group at week 4
timeFrame: Week 4
measure: Proportion of subjects reaching complete healing of NSAID-induced gastropathy in each treatment group at week 4
timeFrame: Week 4
measure: Changes in modified Lanza as compared to visit 1 (baseline) in H.pylori-negative subjects in each treatment group
timeFrame: Baseline, week 2 and week 4
measure: Changes in modified Lanza as compared to visit 1 (baseline) in H.pylori-positive subjects in each treatment group
timeFrame: Baseline, week 2 and week 4
measure: Changes in modified Lanza as compared to Visit 1 (baseline) in subjects with NSAID-induced gastropathy with modified Lanza scale greater than or equal to 5 and <7 at screening in each treatment group
timeFrame: Baseline, week 2 and week 4
measure: Changes in modified Lanza as compared to Visit 1 (baseline) in subjects with NSAID-induced gastropathy with modified Lanza scale =7 at screening in each treatment group
timeFrame: Baseline, week 2 and week 4
measure: Changes in modified Lanza as compared to visit 1 (baseline) in each treatment group
timeFrame: Baseline, week 2 and week 4
measure: Changes in GSRS as compared to visit 1 (baseline) in H.pylori-negative subjects in each treatment group
timeFrame: Baseline, week 2 and week 4
measure: Changes in GSRS as compared to visit 1 (baseline) in H.pylori-positive subjects in each treatment group
timeFrame: Baseline, week 2 and week 4
measure: Changes in GSRS as compared to Visit 1 (baseline) in subjects with NSAID-induced gastropathy with modified Lanza scale greater than or equal to 5 and <7 at screening in each treatment group
timeFrame: Baseline, week 2 and week 4
measure: Changes in GSRS as compared to Visit 1 (baseline) in subjects with NSAID-induced gastropathy with modified Lanza scale =7 at screening in each treatment group
timeFrame: Baseline, week 2 and week 4
measure: Changes in GSRS as compared to visit 1 (baseline) in each treatment group
timeFrame: Baseline, week 2 and week 4
measure: Safety assessed by nature, frequency and severity of Adverse Events (AEs)
timeFrame: Up to day 35
measure: Safety assessed by nature, frequency and severity of Serious Adverse Events (SAEs)
timeFrame: Up to day 35
measure: Number of participants with Physical Exam abnormalities and/or adverse events related to treatment
timeFrame: Up to day 35
measure: Number of participants with vital signs abnormalities and/or adverse events related to treatment
timeFrame: Up to day 35
measure: Safety assessed through esophagogastroduodenoscopy
timeFrame: Up to day 35
measure: Number of participants with laboratory value abnormalities and/or adverse events related to treatment
timeFrame: Up to day 35
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Site RU70001
city: Saint-Petersburg
country: Russian Federation
facility: Site RU70008
city: Saint-Petersburg
country: Russian Federation
facility: Site RU70012
city: Volgograd
country: Russian Federation
facility: Site RU70006
city: Volgograd
country: Russian Federation
facility: Site RU70013
Study officials:
affiliation: Astellas Pharma Russian affiliate
name: Medical Monitor
role: STUDY_DIRECTOR
References: