NSAID-induced Gastropathy Clinical Trial
— BiGARDOfficial 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
| Verified date | September 2017 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 9 |
| Est. completion date | June 13, 2017 |
| Est. primary completion date | May 29, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 ?2-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. |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | Site RU70001 | Moscow | |
| Russian Federation | Site RU70008 | Saint-Petersburg | |
| Russian Federation | Site RU70012 | Saint-Petersburg | |
| Russian Federation | Site RU70006 | Volgograd | |
| Russian Federation | Site RU70013 | Volgograd |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Europe B.V. |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-positive subjects in each treatment group at week 2 | Modified Lanza scale 0-2 scores (inclusively) shall be considered as complete healing | Week 2 | |
| Secondary | Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-negative subjects in each treatment group at week 4 | Subjects reached complete healing of NSAID-induced gastric ulcers and erosions by Visit 2 shall also be analyzed | Week 4 | |
| Secondary | Proportion of subjects reaching complete healing of NSAID-induced gastropathy in H.pylori-positive subjects in each treatment group at week 4 | Subjects reached complete healing of NSAID-induced gastric ulcers and erosions by Visit 2 shall also be analyzed | Week 4 | |
| Secondary | 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 | 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 | Week 2 | |
| Secondary | 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 | 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 | Week 2 | |
| Secondary | 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 | 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 | Week 4 | |
| Secondary | 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 | 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 | Week 4 | |
| Secondary | Proportion of subjects reaching complete healing of NSAID-induced gastropathy in each treatment group at week 4 | Subjects reached complete healing of NSAID-induced gastric ulcers and erosions by Visit 2 shall also be analyzed | Week 4 | |
| Secondary | Changes in modified Lanza as compared to visit 1 (baseline) in H.pylori-negative subjects in each treatment group | The modified Lanza scale is utilized to grade the degree of gastritis | Baseline, week 2 and week 4 | |
| Secondary | Changes in modified Lanza as compared to visit 1 (baseline) in H.pylori-positive subjects in each treatment group | The modified Lanza scale is utilized to grade the degree of gastritis | Baseline, week 2 and week 4 | |
| Secondary | 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 | The modified Lanza scale is utilized to grade the degree of gastritis | Baseline, week 2 and week 4 | |
| Secondary | 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 | The modified Lanza scale is utilized to grade the degree of gastritis | Baseline, week 2 and week 4 | |
| Secondary | Changes in modified Lanza as compared to visit 1 (baseline) in each treatment group | The modified Lanza scale is utilized to grade the degree of gastritis | Baseline, week 2 and week 4 | |
| Secondary | Changes in GSRS as compared to visit 1 (baseline) in H.pylori-negative subjects in each treatment group | 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 | Baseline, week 2 and week 4 | |
| Secondary | Changes in GSRS as compared to visit 1 (baseline) in H.pylori-positive subjects in each treatment group | 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 | Baseline, week 2 and week 4 | |
| Secondary | 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 | 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 | Baseline, week 2 and week 4 | |
| Secondary | 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 | 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 | Baseline, week 2 and week 4 | |
| Secondary | Changes in GSRS as compared to visit 1 (baseline) in each treatment group | The GSRS contains a list of questions on subject's well-being within the period from subject's last visit to study site | Baseline, week 2 and week 4 | |
| Secondary | Safety assessed by nature, frequency and severity of Adverse Events (AEs) | 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 | Up to day 35 | |
| Secondary | Safety assessed by nature, frequency and severity of Serious Adverse Events (SAEs) | 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 | Up to day 35 | |
| Secondary | Number of participants with Physical Exam abnormalities and/or adverse events related to treatment | Number of participants with potentially clinically significant physical exam values | Up to day 35 | |
| Secondary | Number of participants with vital signs abnormalities and/or adverse events related to treatment | Number of participants with potentially clinically significant vital sign values | Up to day 35 | |
| Secondary | Safety assessed through esophagogastroduodenoscopy | 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 | Up to day 35 | |
| Secondary | Number of participants with laboratory value abnormalities and/or adverse events related to treatment | Number of participants with potentially clinically significant laboratory values | Up to day 35 |