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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-132310 | Registry Identifier | Japic CTI | |
| JapicCTI-R140645 | Registry Identifier | JapicCTI |
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To evaluate the efficacy of 4-week lansoprazole (Takepron) therapy for subjective symptomatic improvement in gastroesophageal reflux disease patients with dyspepsia symptoms
This is a special drug use surveillance of lansoprazole (Takepron) with a 4-week observational period, designed to evaluate the efficacy in gastroesophageal reflux disease patients with dyspepsia symptoms (planned sample size, 15000).
The dosage regimen is as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lansoprazole | Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprazole | Drug | • Reflux esophagitis The usual adult dosage is 30 mg of lansoprazole administered orally once daily for up to 8 weeks. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. • Nonerosive gastroesophageal reflux disease Non-erosive gastroesophageal reflux disease The usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Symptom Improvement Rate | Subjective symptoms were evaluated as "Disappeared," "Improved," "No change," "Worsened," or "Unclear." These categories were based on investigator's definitions. At Week 4, the rate of improvement (i.e. the frequency of an evaluation of "Disappeared" + "Improved") was calculated for each symptom. The percentage of participants with Improvement by symptom was reported. | Start of treatment and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events (Adverse Drug Reactions) | Adverse events observed during the observation period were collected by symptom. For adverse drug reactions, frequencies were tabulated by type and seriousness. Adverse events were defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of lansoprazole whether or not it was considered related to treatment. Among these, events that were considered as having a causal relationship with lansoprazole were defined as adverse drug reactions. The rate of participants with adverse events (adverse drug reactions) was reported. |
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Inclusion Criteria:
Exclusion Criteria:
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Gastroesophageal reflux disease with dyspepsia symptoms
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| Name | Affiliation | Role |
|---|---|---|
| Postmarketing Group Manager | Takeda | Study Chair |
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Participants enrolled in the study were clinically diagnosed with reflux esophagitis or non-erosive gastroesophageal reflux disease.
Participants were enrolled in the study during the period between December 8, 2008 and June 30, 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lansoprazole | Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Efficacy analysis set included all enrolled participants with data available (8 patents were excluded for medical reasons; 41 were excluded for other reasons), 1402 patients who did not visit the study site after initial prescription and 861 patients whose questionnaires were not reviewed at either Week 2 or Week 4 were also excluded.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lansoprazole | Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subjective Symptom Improvement Rate | Subjective symptoms were evaluated as "Disappeared," "Improved," "No change," "Worsened," or "Unclear." These categories were based on investigator's definitions. At Week 4, the rate of improvement (i.e. the frequency of an evaluation of "Disappeared" + "Improved") was calculated for each symptom. The percentage of participants with Improvement by symptom was reported. | Efficacy set included all enrolled participants with data available (8 patients were excluded for Investigator's medical reasons; 41 were excluded for other reasons), 1402 patients who did not visit the study site after initial prescription and 861 patients whose questionnaires were not reviewed at either Week 2 or Week 4 were also excluded. | Posted | Number | percentage of participants | Start of treatment and Week 4 |
|
4 Weeks
Safety analysis set included all enrolled participants with data available (8 excluded for Investigator's medical reasons; 41 excluded for other reasons), 1402 did not visit site after initial prescription were excluded 1.Serious adverse events; other (not serious) adverse events; 2.Grouped by organ system with number and frequency of events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lansoprazole | Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute abdomen | Gastrointestinal disorders | MedDRA/J (13.1) | Systematic Assessment |
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There were no control groups in this single-arm study. The observed subjective symptom improvement rates and frequency of adverse drug reactions may be used in an exploratory manner to understand drug use but cannot be treated as verified results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Clinical Science | Takeda | +1-877-825-3327 | clinicaltrialregistry@tpna.com |
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| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
|
| 4 Weeks |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Number | participants |
|
| History of Gastroesophageal Reflux Disease | Number | participants |
|
| Duration of Dyspeptic Symptoms | Number | participants |
|
| Marked Kyphosis | Number | participants |
|
| Helicobacter pylori (H. pylori) Infection at the Start of Takepron Treatment | Number | participants |
|
|
|
| Secondary | Frequency of Adverse Events (Adverse Drug Reactions) | Adverse events observed during the observation period were collected by symptom. For adverse drug reactions, frequencies were tabulated by type and seriousness. Adverse events were defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of lansoprazole whether or not it was considered related to treatment. Among these, events that were considered as having a causal relationship with lansoprazole were defined as adverse drug reactions. The rate of participants with adverse events (adverse drug reactions) was reported. | Safety analysis set included all enrolled participants with data available (8 patients were excluded for Investigator's medical reasons; 41 were excluded for other reasons), 1402 patients who did not visit the study site after initial prescription were also excluded. | Posted | Number | percentage of participants | 4 Weeks |
|
|
|
| 10 |
| 13,514 |
| 0 |
| 13,514 |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA/J (13.1) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA/J (13.1) | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA/J (13.1) | Systematic Assessment |
|
| Joint abscess | Infections and infestations | MedDRA/J (13.1) | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA/J (13.1) | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA/J (13.1) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA/J (13.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA/J (13.1) | Systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA/J (13.1) | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi-site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Title | Measurements |
|---|---|
|
| Rash |
|
| Constipation |
|
| Nausea |
|
| Abdominal distension |
|
| Stomatitis |
|
| Dizziness |
|
| Dysgeusia |
|
| Headache |
|
| Drug eruption |
|
| Feeling abnormal |
|
| Hypoaesthesia |
|
| Somnolence |
|
| Dyspnoea |
|
| Oropharyngeal discomfort |
|
| Pruritus |
|
| Pruritus generalised |
|
| Palpitations |
|
| Abdominal pain |
|
| Abdominal pain lower |
|
| Change of bowel habit |
|
| Meteorism |
|
| Gastrooesophageal reflux disease |
|
| Oral discomfort |
|
| Oral mucosal eruption |
|
| Abdominal discomfort |
|
| Chest pain |
|
| Face oedema |
|
| Oedema |
|
| Thirst |
|
| Decreased appetite |
|
| Back pain |
|
| Sleep disorder |
|
| Cough |
|
| Acne |
|
| Eczema |
|
| Erythema multiforme |
|
| Toxic skin eruption |
|
| Hot flush |
|