The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.
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1 The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall potential risks or benefits of a product which are based on an evaluation of an entire research program. Before prescribing any Takeda products, healthcare professionals should consult prescribing information for the product approved in their country.
2 STUDY SYNOPSIS Name of Sponsor/Company: Takeda Pharmaceutical Company Limited Name of Product: Takepron Intravenous 30 mg Name of Active Ingredient: Lansoprazole Official title: Takepron Intravenous 30 mg Specified Drug-use Survey [Hemostatic Effect/Rebleeding Rate] Brief title: Lansoprazole Intravenous 30 mg Specified Drug-use Survey [Hemostatic Effect/Rebleeding Rate] Objectives: The objective of this study was to evaluate the safety (frequency of adverse events) and efficacy (hemostatic effect, rate of rebleeding after confirmation of hemostasis) of administration of Takepron Intravenous 30 mg (hereinafter referred to as the drug). Safety: Confirmation of the frequency of adverse events (symptoms, frequency, and seriousness) during the observation period Efficacy: (i) Hemostatic effect Evaluation of the time to hemostasis confirmed by endoscopy after the start of treatment with the drug (ii) Rebleeding rate Evaluation of the presence or absence of rebleeding during treatment with the drug and 8 weeks after the completion of treatment with the drug in patients for whom hemostasis was confirmed by endoscopy after the start of treatment with the drug Study design: Observational study Sample size: 1120 patients Study population:
3 Patients with the following diseases for whom oral administration is not feasible: Gastric ulcer, duodenal ulcer, acute stress ulcer, and acute gastric mucosal lesion (all of which should be accompanied by bleeding) Study period: January 29, 2007 to March 31, 2010 Definition of Outcome: Primary Endpoint <Safety> Frequency of adverse drug reactions Secondary Endpoints <Efficacy> Statistical analysis: <Safety> For adverse drug reactions that occur during the observation period, rate of onset (hereinafter referred to as frequency), the number of patients, the number of events, and types of events were tabulated. In addition, the frequency of adverse drug reactions was tabulated by seriousness, time to onset, and outcome. <Efficacy> In patients for whom hemostatic effect was observed, the number of patients analyzed, the number of patients demonstrating each hemostatic effect, and the efficacy rate were tabulated. In patients for whom hemostasis was confirmed during treatment with the drug, the number of patients for whom hemostasis was confirmed during treatment, the number of patients who experienced rebleeding after hemostasis during treatment, and the rebleeding rate were tabulated. In patients for whom hemostasis was confirmed at the end of treatment with the drug and for
4 whom the presence or absence of hemostasis was confirmed after the completion of treatment with the drug, stratification was performed according to the time to rebleeding: data on the time to rebleeding was obtained from the results of the presence or absence of hemostasis during the 56 days after the completion of treatment with the drug, and the number of patients for whom hemostasis was confirmed, the number of patients who experienced rebleeding after hemostasis, and the cumulative rebleeding rate were tabulated by stratum (days). The cumulative rebleeding rate for the period from the date of completion of treatment with the drug to the date rebleeding was observed was calculated using the Kaplan-Meier method. Summary of Results: 1. Safety (1) Occurrence of adverse drug reactions - Adverse drug reactions were observed in 35 (3.23%, 42 events) out of 1084 patients (safety assessment population). - The most common adverse drug reactions (3 or more events) were gastric hemorrhage (7 events), diarrhea (3 events), hepatic function abnormal (3 events), liver disorder (3 events), pyrexia (3 events), and white blood cell count decreased (3 events). (2) Occurrence of serious adverse drug reactions - Serious adverse drug reactions were reported in 9 patients (0.83%, 13 events). - The serious adverse drug reactions reported were gastric hemorrhage (4 events), insomnia (1 event), restlessness (1 event), depressive symptom (1 event), depressed level of consciousness (1 event), diarrhea (1 event), gastric ulcer hemorrhage (1 event), cholangitis (1 event), muscular weakness (1 event), and white blood cell count decreased (1 event). (3) Time to onset of adverse drug reactions - 39 out of the 42 adverse drug reactions occurred within 14 days after the start of treatment. 2. Efficacy - Among the 1052 patients for whom hemostatic effects were observed, the efficacy rate ("markedly improved" + "moderately improved" + "slightly improved") was 90.3% (950/1052 patients). - Among the 898 patients for whom hemostatic effect was confirmed by endoscopy,
5 the efficacy rate ("markedly improved" + "moderately improved" + "slightly improved") was 91.6% (821/896 patients). - Among the 819 patients for whom hemostasis was confirmed at any time during treatment with the drug, the rebleeding rate after hemostasis during treatment with the drug was 1.1% (9/819 patients). - Among the 745 patients for whom hemostasis was confirmed by endoscopy at any time during treatment with the drug, the rebleeding rate after hemostasis during treatment with the drug was 1.2% (9/745 patients). - Among the 497 patients for whom hemostasis was confirmed at the final evaluation point during treatment with the drug and for whom the presence or absence of hemostasis was confirmed after the completion of treatment with the drug, the cumulative rebleeding rate 8 weeks after the completion of treatment with the drug was 5.8% and 19 out of 24 patients experienced rebleeding within 7 days after the completion of treatment with the drug. - Among the 389 patients for whom hemostasis was confirmed by endoscopy at the final evaluation point during treatment with the drug and for whom the presence or absence of hemostasis was confirmed after the completion of treatment with the drug, the cumulative rebleeding rate 8 weeks after the completion of treatment with the drug was 7.1% and 17 out of 22 patients experienced rebleeding within 7 days after the completion of treatment with the drug. Date of the report: October 2, 2015
The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.
The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall
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