NSAID-induced Gastropathy
Conditions
Keywords
De-Nol, NSAID-induced gastropathy, Pantoprazole, Bismuth tripotassium dicitrate, Russia
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
Interventions
DRUGbismuth tripotassium dicitrate
oral
DRUGpantoprazole
oral
Sponsors
Astellas Pharma Europe B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects in each group reaching complete healing of NSAID-induced gastropathy at week 2 of therapy | Week 2 | Modified Lanza score 0-2 (inclusively) shall be considered as healing. The modified Lanza scale is utilized to grade the degree of gastritis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-positive subjects in each treatment group at week 2 | Week 2 | Modified Lanza scale 0-2 scores (inclusively) shall be considered as complete healing |
| Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-negative subjects in each treatment group at week 4 | Week 4 | Subjects reached complete healing of NSAID-induced gastric ulcers and erosions by Visit 2 shall also be analyzed |
| Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-positive subjects in each treatment group at week 4 | Week 4 | Subjects reached complete healing of NSAID-induced gastric ulcers and erosions by Visit 2 shall also be analyzed |
| 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 | The modified Lanza scale is utilized to grade the degree of gastritis. Modified Lanza scale 0-2 scores (inclusively) shall be considered as complete healing |
| 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 | Week 2 | The modified Lanza scale is utilized to grade the degree of gastritis. Modified Lanza scale 0-2 scores (inclusively) shall be considered as complete healing |
| 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 | Week 4 | The modified Lanza scale is utilized to grade the degree of gastritis. Modified Lanza scale 0-2 scores (inclusively) shall be considered as complete healing. Subjects reached complete healing of NSAID-induced gastric ulcers and erosions by Visit 2 shall also be analyzed |
| 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 | Week 4 | The modified Lanza scale is utilized to grade the degree of gastritis. Modified Lanza scale 0-2 scores (inclusively) shall be considered as complete healing. Subjects reached complete healing of NSAID-induced gastric ulcers and erosions by Visit 2 shall also be analyzed |
| Proportion of subjects reaching complete healing of NSAID-induced gastropathy in each treatment group at week 4 | Week 4 | Subjects reached complete healing of NSAID-induced gastric ulcers and erosions by Visit 2 shall also be analyzed |
| Changes in modified Lanza as compared to visit 1 (baseline) in H.pylori-negative subjects in each treatment group | Baseline, week 2 and week 4 | The modified Lanza scale is utilized to grade the degree of gastritis |
| Changes in modified Lanza as compared to visit 1 (baseline) in H.pylori-positive subjects in each treatment group | Baseline, week 2 and week 4 | The modified Lanza scale is utilized to grade the degree of gastritis |
| 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 | Baseline, week 2 and week 4 | The modified Lanza scale is utilized to grade the degree of gastritis |
| 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 | Baseline, week 2 and week 4 | The modified Lanza scale is utilized to grade the degree of gastritis |
| Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-negative subjects in each treatment group at week 2 | Week 2 | Modified Lanza scale 0-2 scores (inclusively) shall be considered as complete healing |
| Changes in GSRS as compared to visit 1 (baseline) in H.pylori-negative subjects in each treatment group | Baseline, week 2 and week 4 | Gastrointestinal Symptom Rating Scale (GSRS). The GSRS contains a list of questions on subject's well-being within the period from subject's last visit to study site |
| Changes in GSRS as compared to visit 1 (baseline) in H.pylori-positive subjects in each treatment group | Baseline, week 2 and week 4 | Gastrointestinal Symptom Rating Scale (GSRS). The GSRS contains a list of questions on subject's well-being within the period from subject's last visit to study site |
| 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 | Baseline, week 2 and week 4 | The GSRS contains a list of questions on subject's well-being within the period from subject's last visit to study site. The modified Lanza scale is utilized to grade the degree of gastritis |
| 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 | Baseline, week 2 and week 4 | The GSRS contains a list of questions on subject's well-being within the period from subject's last visit to study site. The modified Lanza scale is utilized to grade the degree of gastritis |
| Changes in GSRS as compared to visit 1 (baseline) in each treatment group | Baseline, week 2 and week 4 | The GSRS contains a list of questions on subject's well-being within the period from subject's last visit to study site |
| Safety assessed by nature, frequency and severity of Adverse Events (AEs) | Up to day 35 | An AE is defined as any untoward medical occurrence in a subject administered a study drug or has undergone study procedures and which does not necessarily have a causal relationship with this treatment |
| Safety assessed by nature, frequency and severity of Serious Adverse Events (SAEs) | Up to day 35 | Adverse event (AE) is considered serious if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important events |
| Number of participants with Physical Exam abnormalities and/or adverse events related to treatment | Up to day 35 | Number of participants with potentially clinically significant physical exam values |
| Number of participants with vital signs abnormalities and/or adverse events related to treatment | Up to day 35 | Number of participants with potentially clinically significant vital sign values |
| Safety assessed through esophagogastroduodenoscopy | Up to day 35 | Amount of gastric content and its nature (mucus, bile, blood), gastric mucosa condition (edema, hyperemia, erosions, mucosal hemorrages, atrophy, hypertrophy) shall be evaluated during esophagogastroduodenoscopy |
| Number of participants with laboratory value abnormalities and/or adverse events related to treatment | Up to day 35 | Number of participants with potentially clinically significant laboratory values |
| Changes in modified Lanza as compared to visit 1 (baseline) in each treatment group | Baseline, week 2 and week 4 | The modified Lanza scale is utilized to grade the degree of gastritis |
Countries
Russia
Outcome results
None listed