Long-term Use of Takepron Capsules on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin

NCT02099682 | Completed Results

• 3 other identifiers: 467-712JapicCTI-142414JapicCTI-R150735
• Study Type: observational
• Target: 3,366
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Gastric or Duodenal Ulcers

Keywords

Pharmacological therapy

Outcome Measures

Primary Outcomes (1)

• Frequency of Adverse Drug Reactions

  Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.

  12 months

Secondary Outcomes (7)

• Presence or Absence of Endoscopic Examinations

  From baseline to 12 months

• Presence of Gastric or Duodenal Ulcer

  From baseline to 12 months

• Presence of Gastric or Duodenal Hemorrhagic Lesion

  From baseline to 12 months

• Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion

  From baseline to 12 months

• Treatment for Gastric/Duodenal Ulcer or Lesion

  From baseline to 12 months

Study Arms (1)

Lansoprazole 15 mg

Lansoprazole 15 mg orally once daily

Drug: Lansoprazole

Interventions

Lansoprazole DRUG

Lansoprazole Capsules 15/ OD Tablets

Also known as: Takepron Capsules 15/ OD Tablets

Lansoprazole 15 mg

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Gastric or duodenal ulcers

You may qualify if:

• (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)

You may not qualify if:

• (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

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Conditions

Duodenal Ulcer

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Medical Director, Clinical Science
• Organization: Takeda

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Postmarketing Group Manager

  Takeda

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: March 31, 2014
• Study Start: August 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: November 4, 2016
• Results First Posted: June 25, 2015

Record last verified: 2016-09