Gastric or Duodenal Ulcers
Conditions
Keywords
Pharmacological therapy
Brief summary
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)
Detailed description
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.
Interventions
DRUGLansoprazole
Lansoprazole Capsules 15 mg/ Orally Disintegrating (OD) Tablets 15 mg
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Adverse Drug Reactions | 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
| Measure | Time frame | Description |
|---|---|---|
| Presence of Gastric or Duodenal Ulcer | From baseline to 12 months | Summary of data on the presence or absence of gastric or duodenal ulcer. |
| Presence of Onset of Gastric or Duodenal Hemorrhagic Lesion | From baseline to 12 months | Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesion. |
| Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion | From baseline to 12 months | Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion. |
| Presence or Absence of Endoscopic Examinations | From baseline to 12 months | Summary of data on the presence or absence of gastric or duodenal ulcers by using endoscopic examinations. |
| Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | 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. |
| Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | From baseline to 12 months | Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions. |
| Treatment for Gastric/Duodenal Ulcer or Lesion | From baseline to 12 months | Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions. |
Participant flow
Recruitment details
Participants took part in the study at 501 investigative sites in Japan from October 2010 to March 2014 (N=3,502).
Pre-assignment details
Patients with a history of gastric or duodenal ulcers and requiring long-term use of nonsteroidal anti-inflammatory drugs were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Lansoprazole 15 mg Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months. | 3,302 |
| Total | 3,302 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Data Not Available | 30 |
| Overall Study | Lost to Follow-up | 141 |
| Overall Study | Other | 29 |
Baseline characteristics
| Characteristic | Lansoprazole 15 mg |
|---|---|
| Age, Continuous | 67.9 years STANDARD_DEVIATION 14.21 |
| Details of the History of Gastric or Duodenal Ulcers: Site of Disease Gastric ulcer | 2632 participants |
| Details of the History of Gastric or Duodenal Ulcers: Site of Disease Gastroduodenal ulcer | 207 participants |
| Details of the History of Gastric or Duodenal Ulcers: Site of Disease Unknown | 490 participants |
| Details of the History of Gastric or Duodenal Ulcers: Time of Emergence ≥ 1 year before treatment | 449 participants |
| Details of the History of Gastric or Duodenal Ulcers: Time of Emergence <6 months before treatment | 161 participants |
| Details of the History of Gastric or Duodenal Ulcers: Time of Emergence ≥ 6 months to < 1 year before treatment | 63 participants |
| Details of the History of Gastric or Duodenal Ulcers: Time of Emergence Unknown | 2629 participants |
| Presence or Absence of H. Pylori Infection Negative | 276 participants |
| Presence or Absence of H. Pylori Infection Positive | 55 participants |
| Presence or Absence of H. Pylori Infection Unknown | 2971 participants |
| Purpose of Non-steroidal Anti-Inflammatory Drug (NSAID) Treatment Osteoarthritis | 1729 participants |
| Purpose of Non-steroidal Anti-Inflammatory Drug (NSAID) Treatment Other | 1116 participants |
| Purpose of Non-steroidal Anti-Inflammatory Drug (NSAID) Treatment Rheumatoid arthritis | 573 participants |
| Sex: Female, Male Female | 2268 Participants |
| Sex: Female, Male Male | 1034 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3,302 |
| serious Total, serious adverse events | 50 / 3,302 |
Outcome results
Primary
Frequency of Adverse Drug Reactions
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.
Time frame: 12 months
Population: Safety analysis set (SAS) - All participants who received at least 1 dose of open-label study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Bronchitis | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Colon cancer | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Nausea | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Stomatitis | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Eczema | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Hyperhidrosis | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Thirst | 2 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Colitis microscopic | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Depression | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Cervical radiculopathy | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Atrial fibrillation | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Cardiac failure | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Myocardial ischaemia | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Abdominal discomfort | 4 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Abdominal pain upper | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Colitis | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Constipation | 2 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Diarrhoea | 8 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Enterocolitis | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Oral mucosal blistering | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Faeces soft | 2 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Rash | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Generalised erythema | 1 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Osteoporosis | 2 participants |
| Lansoprazole 15 mg | Frequency of Adverse Drug Reactions | Feeling abnormal | 1 participants |
Secondary
Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions
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.
Time frame: From baseline to 12 months
Population: Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lansoprazole 15 mg | Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Takepron Capsule or OD Tablets 15 mg | 4 participants |
| Lansoprazole 15 mg | Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Takepron Capsule or OD Tablet 30 mg | 1 participants |
| Lansoprazole 15 mg | Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Rabeprazole tablet 10 mg | 1 participants |
| Lansoprazole 15 mg | Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Rabeprazole tablet 20 mg | 1 participants |
| Lansoprazole 15 mg | Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | H2 receptor antagonist (oral) | 1 participants |
| Lansoprazole 15 mg | Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Other peptic ulcer medication | 4 participants |
| Lansoprazole 15 mg | Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Endoscopic hemostasis | 1 participants |
| Lansoprazole 15 mg | Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Other | 4 participants |
Secondary
Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion
Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion.
Time frame: From baseline to 12 months
Population: Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lansoprazole 15 mg | Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion | No | 3237 participants |
| Lansoprazole 15 mg | Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion | Yes | 11 participants |
Secondary
Presence of Gastric or Duodenal Ulcer
Summary of data on the presence or absence of gastric or duodenal ulcer.
Time frame: From baseline to 12 months
Population: Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lansoprazole 15 mg | Presence of Gastric or Duodenal Ulcer | No | 3239 Participants |
| Lansoprazole 15 mg | Presence of Gastric or Duodenal Ulcer | Yes | 9 Participants |
Secondary
Presence of Onset of Gastric or Duodenal Hemorrhagic Lesion
Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesion.
Time frame: From baseline to 12 months
Population: Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lansoprazole 15 mg | Presence of Onset of Gastric or Duodenal Hemorrhagic Lesion | Yes | 4 participants |
| Lansoprazole 15 mg | Presence of Onset of Gastric or Duodenal Hemorrhagic Lesion | No | 3244 participants |
Secondary
Presence or Absence of Endoscopic Examinations
Summary of data on the presence or absence of gastric or duodenal ulcers by using endoscopic examinations.
Time frame: From baseline to 12 months
Population: Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lansoprazole 15 mg | Presence or Absence of Endoscopic Examinations | No | 3098 participants |
| Lansoprazole 15 mg | Presence or Absence of Endoscopic Examinations | Yes | 150 participants |
Secondary
Treatment for Gastric/Duodenal Ulcer or Lesion
Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions.
Time frame: From baseline to 12 months
Population: Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lansoprazole 15 mg | Treatment for Gastric/Duodenal Ulcer or Lesion | No | 0 participants |
| Lansoprazole 15 mg | Treatment for Gastric/Duodenal Ulcer or Lesion | Yes | 11 participants |
Secondary
Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions
Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions.
Time frame: From baseline to 12 months
Population: Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Other peptic ulcer medication - Resolving | 1 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Other - Resolving | 3 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Takepron 15 mg - Resolving | 3 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Takepron 15 mg - Unknown | 1 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Takepron 30 mg - Resolved | 1 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Rabeprazole 10 mg _Resolved | 1 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Rabeprazole 20 mg - Resolved | 1 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | H2 receptor antagonist - Resolved | 1 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Other peptic ulcer medication - Resolved | 3 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Endoscopic hemostasis - Resolving | 1 participants |
| Lansoprazole 15 mg | Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions | Other - Resolved | 1 participants |