N/A
N=3,366
Long-term Use of Takepron Capsules on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin
Gastric or Duodenal Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT02099682 ↗Enrolled (actual)
3,366
Serious AEs
3.9%
Results posted
Jun 2015
Primary outcome: Primary: Frequency of Adverse Drug Reactions — 1; 1; 1; 1 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Lansoprazole (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Adverse Drug Reactions |
1; 1; 1; 1; 2; 1 | — |
| SECONDARY Presence or Absence of Endoscopic Examinations |
2773; 437 | — |
| SECONDARY Presence of Gastric or Duodenal Ulcer |
3190; 20 | — |
| SECONDARY Presence of Gastric or Duodenal Hemorrhagic Lesion |
3201; 9 | — |
| SECONDARY Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion |
3186; 24 | — |
| SECONDARY Treatment for Gastric/Duodenal Ulcer or Lesion |
0; 24 | — |
| SECONDARY Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions |
15; 2; 2; 1; 2; 1 | — |
| SECONDARY Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions |
9; 6; 1; 1; 1; 1 | — |
Summary
The purpose of this study is to investigate the safety and efficacy of long-term administration of lansoprazole (Takepron) for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin
Eligibility Criteria
Inclusion Criteria
- (1) Patients with a history of gastric or duodenal ulcers (2) Patients requiring long-term use of low-dose aspirin (81-324 mg once daily) as prophylaxis for thromboembolism (3) Patients taking low-dose oral aspirin (81-324 mg once daily) at the start of administration of lansoprazole (including patients who start low-dose aspirin on the same day as the start of administration of lansoprazole)
Exclusion Criteria
- (1) Patients with gastric or duodenal ulcer (in the active [A1, A2] or healing [H1, H2] stage if assessed endoscopically) at the start of administration of lansoprazole (2) Patients with active upper gastrointestinal hemorrhage at the start of administration of lansoprazole (3) Patients with contraindications for lansoprazole
Data sourced from ClinicalTrials.gov (NCT02099682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.