Gastroesophageal Reflux Disease With Dyspepsia Symptoms
Conditions
Brief summary
To evaluate the efficacy of 4-week lansoprazole (Takepron) therapy for subjective symptomatic improvement in gastroesophageal reflux disease patients with dyspepsia symptoms
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.
Interventions
DRUGLansoprazole
• 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.
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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
1. Patients who have taken any proton pump inhibitors (including Takepron) within 4 weeks before the start of Takepron administration 2. Patients taking antidepressants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Recruitment details
Participants were enrolled in the study during the period between December 8, 2008 and June 30, 2010.
Pre-assignment details
Participants enrolled in the study were clinically diagnosed with reflux esophagitis or non-erosive gastroesophageal reflux disease.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12,653 |
| Total | 12,653 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Data Not Available | 49 |
| Overall Study | Lost to Follow-up | 861 |
| Overall Study | Voluntary Withdrawal | 1,402 |
Baseline characteristics
| Characteristic | Lansoprazole |
|---|---|
| Age, Customized < 65 years | 6691 participants |
| Age, Customized ≥ 65 years | 5962 participants |
| Body Mass Index (BMI) BMI < 25 kg/m^2 | 6043 participants |
| Body Mass Index (BMI) BMI ≥ 25 kg/m^2 and < 30 kg/m^2 | 3083 participants |
| Body Mass Index (BMI) BMI ≥ 30 kg/m^2 | 472 participants |
| Body Mass Index (BMI) BMI Unknown | 3055 participants |
| Duration of Dyspeptic Symptoms < 1 month | 5832 participants |
| Duration of Dyspeptic Symptoms > 1 month and ≤ 3 months | 3080 participants |
| Duration of Dyspeptic Symptoms > 3 months and ≤ 6 months | 802 participants |
| Duration of Dyspeptic Symptoms > 6 months | 1442 participants |
| Duration of Dyspeptic Symptoms Unknown | 1497 participants |
| Helicobacter pylori (H. pylori) Infection at the Start of Takepron Treatment Negative | 2214 participants |
| Helicobacter pylori (H. pylori) Infection at the Start of Takepron Treatment Positive | 689 participants |
| Helicobacter pylori (H. pylori) Infection at the Start of Takepron Treatment Unknown | 9750 participants |
| History of Gastroesophageal Reflux Disease Initial | 7128 participants |
| History of Gastroesophageal Reflux Disease Recurrence | 2498 participants |
| History of Gastroesophageal Reflux Disease Unknown | 3027 participants |
| Marked Kyphosis No | 12148 participants |
| Marked Kyphosis Yes | 505 participants |
| Race/Ethnicity, Customized Asian | 12653 participants |
| Region of Enrollment Japan | 12653 participants |
| Sex: Female, Male Female | 7417 Participants |
| Sex: Female, Male Male | 5236 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 13,514 |
| serious Total, serious adverse events | 10 / 13,514 |
Outcome results
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.
Time frame: Start of treatment and Week 4
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lansoprazole | Subjective Symptom Improvement Rate | Acid regurgitation | 73.5 percentage of participants |
| Lansoprazole | Subjective Symptom Improvement Rate | Postorandial fullness | 68.6 percentage of participants |
| Lansoprazole | Subjective Symptom Improvement Rate | Heartburn | 75.7 percentage of participants |
| Lansoprazole | Subjective Symptom Improvement Rate | Early satiety | 65.3 percentage of participants |
| Lansoprazole | Subjective Symptom Improvement Rate | Epigastric pain | 69.1 percentage of participants |
| Lansoprazole | Subjective Symptom Improvement Rate | Epigastric burning | 73.0 percentage of participants |
| Lansoprazole | Subjective Symptom Improvement Rate | Upper abdominal bloating | 64.8 percentage of participants |
| Lansoprazole | Subjective Symptom Improvement Rate | Nausea/vomiting | 66.4 percentage of participants |
| Lansoprazole | Subjective Symptom Improvement Rate | Belching | 61.6 percentage of 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.
Time frame: 4 Weeks
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Adverse drug reaction(s) | 0.69 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Diarrhoea | 0.16 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Urticaria | 0.08 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Rash | 0.07 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Constipation | 0.04 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Nausea | 0.04 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Abdominal distension | 0.02 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Stomatitis | 0.02 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Dizziness | 0.02 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Dysgeusia | 0.02 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Headache | 0.02 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Drug eruption | 0.02 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Feeling abnormal | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Hypoaesthesia | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Somnolence | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Dyspnoea | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Oropharyngeal discomfort | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Pruritus | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Pruritus generalised | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Palpitations | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Abdominal pain | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Abdominal pain lower | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Change of bowel habit | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Meteorism | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Gastrooesophageal reflux disease | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Oral discomfort | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Oral mucosal eruption | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Abdominal discomfort | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Chest pain | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Face oedema | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Oedema | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Thirst | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Decreased appetite | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Back pain | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Sleep disorder | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Cough | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Acne | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Eczema | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Erythema multiforme | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Toxic skin eruption | 0.01 percentage of participants |
| Lansoprazole | Frequency of Adverse Events (Adverse Drug Reactions) | Hot flush | 0.01 percentage of participants |