LEGEND: Lansoprazole Tablets Special Drug Use Surveillance Gastroesophageal Reflux Disease With Dyspepsia Symptoms
Study Details
Study Description
Brief Summary
To evaluate the efficacy of 4-week lansoprazole (Takepron) therapy for subjective symptomatic improvement in gastroesophageal reflux disease patients with dyspepsia symptoms
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
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:
-
For reflux esophagitis, the usual adult dosage is 30 mg of lansoprazole administered orally once daily for up to 8 weeks. For maintenance treatment 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.
-
For non-erosive gastroesophageal reflux disease, the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Lansoprazole
• 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Subjective Symptom Improvement Rate [Start of treatment and Week 4]
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.
Secondary Outcome Measures
- Frequency of Adverse Events (Adverse Drug Reactions) [4 Weeks]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with heartburn or acid regurgitation at the start of Takepron administration* , or patients without heartburn and acid regurgitation, but with endoscopic findings classified as Los Angeles grade A-D at the start of Takepron therapy.
-
Patients with symptoms of dyspepsia (i.e., postprandial fullness, early satiation, epigastric pain, epigastric burning, upper abdominal bloating, nausea/vomiting, or belching) at the start of Takepron administration* *These patients must have answered "never, " "sometimes/mild," "often/moderate," or "frequent/severe" on a 4-point scale questionnaire about subjective symptoms.
Exclusion Criteria:
-
Patients who have taken any proton pump inhibitors (including Takepron) within 4 weeks before the start of Takepron administration
-
Patients taking antidepressants
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Takeda
Investigators
- Study Chair: Postmarketing Group Manager, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 467-531
- JapicCTI-132310
- JapicCTI-R140645
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled in the study during the period between December 8, 2008 and June 30, 2010. |
|---|---|
| Pre-assignment Detail | Participants enrolled in the study were clinically diagnosed with reflux esophagitis or non-erosive gastroesophageal reflux disease. |
| Arm/Group Title | Lansoprazole |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 14965 |
| COMPLETED | 12653 |
| NOT COMPLETED | 2312 |
Baseline Characteristics
| Arm/Group Title | Lansoprazole |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 12653 |
| Age, Customized (participants) [Number] | |
| < 65 years |
6691
52.9%
|
| ≥ 65 years |
5962
47.1%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
7417
58.6%
|
| Male |
5236
41.4%
|
| Race/Ethnicity, Customized (participants) [Number] | |
| Asian |
12653
100%
|
| Region of Enrollment (participants) [Number] | |
| Japan |
12653
100%
|
| Body Mass Index (BMI) (participants) [Number] | |
| BMI < 25 kg/m^2 |
6043
47.8%
|
| BMI ≥ 25 kg/m^2 and < 30 kg/m^2 |
3083
24.4%
|
| BMI ≥ 30 kg/m^2 |
472
3.7%
|
| BMI Unknown |
3055
24.1%
|
| History of Gastroesophageal Reflux Disease (participants) [Number] | |
| Initial |
7128
56.3%
|
| Recurrence |
2498
19.7%
|
| Unknown |
3027
23.9%
|
| Duration of Dyspeptic Symptoms (participants) [Number] | |
| < 1 month |
5832
46.1%
|
| > 1 month and ≤ 3 months |
3080
24.3%
|
| > 3 months and ≤ 6 months |
802
6.3%
|
| > 6 months |
1442
11.4%
|
| Unknown |
1497
11.8%
|
| Marked Kyphosis (participants) [Number] | |
| No |
12148
96%
|
| Yes |
505
4%
|
| Helicobacter pylori (H. pylori) Infection at the Start of Takepron Treatment (participants) [Number] | |
| Negative |
2214
17.5%
|
| Positive |
689
5.4%
|
| Unknown |
9750
77.1%
|
Outcome Measures
| Title | Subjective Symptom Improvement Rate |
|---|---|
| Description | 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. |
| Time Frame | Start of treatment and Week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Lansoprazole |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 12653 |
| Heartburn |
75.7
0.6%
|
| Acid regurgitation |
73.5
0.6%
|
| Postorandial fullness |
68.6
0.5%
|
| Early satiety |
65.3
0.5%
|
| Epigastric pain |
69.1
0.5%
|
| Epigastric burning |
73.0
0.6%
|
| Upper abdominal bloating |
64.8
0.5%
|
| Nausea/vomiting |
66.4
0.5%
|
| Belching |
61.6
0.5%
|
| Title | Frequency of Adverse Events (Adverse Drug Reactions) |
|---|---|
| Description | 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. |
| Time Frame | 4 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Lansoprazole |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 13514 |
| Adverse drug reaction(s) |
0.69
0%
|
| Diarrhoea |
0.16
0%
|
| Urticaria |
0.08
0%
|
| Rash |
0.07
0%
|
| Constipation |
0.04
0%
|
| Nausea |
0.04
0%
|
| Abdominal distension |
0.02
0%
|
| Stomatitis |
0.02
0%
|
| Dizziness |
0.02
0%
|
| Dysgeusia |
0.02
0%
|
| Headache |
0.02
0%
|
| Drug eruption |
0.02
0%
|
| Feeling abnormal |
0.01
0%
|
| Hypoaesthesia |
0.01
0%
|
| Somnolence |
0.01
0%
|
| Dyspnoea |
0.01
0%
|
| Oropharyngeal discomfort |
0.01
0%
|
| Pruritus |
0.01
0%
|
| Pruritus generalised |
0.01
0%
|
| Palpitations |
0.01
0%
|
| Abdominal pain |
0.01
0%
|
| Abdominal pain lower |
0.01
0%
|
| Change of bowel habit |
0.01
0%
|
| Meteorism |
0.01
0%
|
| Gastrooesophageal reflux disease |
0.01
0%
|
| Oral discomfort |
0.01
0%
|
| Oral mucosal eruption |
0.01
0%
|
| Abdominal discomfort |
0.01
0%
|
| Chest pain |
0.01
0%
|
| Face oedema |
0.01
0%
|
| Oedema |
0.01
0%
|
| Thirst |
0.01
0%
|
| Decreased appetite |
0.01
0%
|
| Back pain |
0.01
0%
|
| Sleep disorder |
0.01
0%
|
| Cough |
0.01
0%
|
| Acne |
0.01
0%
|
| Eczema |
0.01
0%
|
| Erythema multiforme |
0.01
0%
|
| Toxic skin eruption |
0.01
0%
|
| Hot flush |
0.01
0%
|
Adverse Events
| Time Frame | 4 Weeks | |
|---|---|---|
| Adverse Event Reporting Description | 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 | |
| Arm/Group Title | Lansoprazole | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| Lansoprazole | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Lansoprazole | ||
| Affected / at Risk (%) | # Events | |
| Total | 10/13514 (0.1%) | |
| Gastrointestinal disorders | ||
| Acute abdomen | 1/13514 (0%) | 1 |
| Colitis ischaemic | 1/13514 (0%) | 1 |
| Hepatobiliary disorders | ||
| Cholecystitis | 2/13514 (0%) | 2 |
| Infections and infestations | ||
| Abscess limb | 1/13514 (0%) | 1 |
| Joint abscess | 1/13514 (0%) | 1 |
| Investigations | ||
| Blood glucose increased | 1/13514 (0%) | 1 |
| Nervous system disorders | ||
| Cerebral haemorrhage | 1/13514 (0%) | 1 |
| Cerebral infarction | 1/13514 (0%) | 1 |
| Dizziness | 1/13514 (0%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Toxic skin eruption | 1/13514 (0%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Lansoprazole | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/13514 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Medical Director, Clinical Science |
|---|---|
| Organization | Takeda |
| Phone | +1-877-825-3327 |
| clinicaltrialregistry@tpna.com |
- 467-531
- JapicCTI-132310
- JapicCTI-R140645