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Completed

NCT Number: NCT02099708

Long-term Use of Takepron on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs

The purpose of this study is to investigate the safety and efficacy of long-term administration of lansoprazole (Takepron) therapy for up to 12 months in the routine clinical setting in patients receiving oral non-steroidal anti-inflammatory drugs (NSAIDs)

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Key information

Conditions

Gastric or Duodenal Ulcers Digestive System Diseases Duodenal Diseases Duodenal Ulcer Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

This is a special survey on long-term use (for up to 12 months) of lansoprazole (Takepron) to determine the incidence of adverse drug reactions in the routine clinical setting in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs).

The usual adult dosage is 15 mg of lansoprazole administered orally once daily.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (1) Patients with a history of gastric or duodenal ulcers (2) Patients requiring long-term use of NSAIDs for reasons such as pain management for rheumatoid arthritis or osteoarthritis (3) Patients taking oral NSAIDs at the start of administration of lansoprazole (including patients who start NSAIDs 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

Treatment and study plan

Lansoprazole

Drug

Lansoprazole Capsules 15 mg/ Orally Disintegrating (OD) Tablets 15 mg

Other names: Takepron Capsules 15 mg, Takepron Orally Disintegrating (OD) Tablets 15 mg

Primary outcomes

  1. Frequency of Adverse Drug Reactions

    Time frame: 12 months

    Frequency was defined as the number of participants for each adverse event 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.

Secondary outcomes

  1. Presence or Absence of Endoscopic Examinations

    Time frame: From baseline to 12 months

    Summary of data on the presence or absence of gastric or duodenal ulcers by using endoscopic examinations.

  2. Presence of Gastric or Duodenal Ulcer

    Time frame: From baseline to 12 months

    Summary of data on the presence or absence of gastric or duodenal ulcer.

  3. Presence of Onset of Gastric or Duodenal Hemorrhagic Lesion

    Time frame: From baseline to 12 months

    Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesion.

  4. Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion

    Time frame: From baseline to 12 months

    Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion.

  5. Treatment for Gastric/Duodenal Ulcer or Lesion

    Time frame: From baseline to 12 months

    Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions.

  6. Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions

    Time frame: From baseline to 12 months

    Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions.

    Participants could be counted in more than 1 treatment category.

  7. Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions

    Time frame: From baseline to 12 months

    Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Takepron Capsules 15/ Orally Dispersing（OD） Tablets 15 Special Drug Use Surveillance Long-term Use Survey on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Mar 31, 2014
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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