N/A
N=14,965
Lansoprazole Tablets Special Drug Use Surveillance Gastroesophageal Reflux Disease With Dyspepsia Symptoms
Gastroesophageal Reflux Disease With Dyspepsia Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT01990339 ↗Enrolled (actual)
14,965
Serious AEs
0.1%
Results posted
Nov 2014
Primary outcome: Primary: Subjective Symptom Improvement Rate — 75.7; 73.5; 68.6; 65.3 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Lansoprazole (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Symptom Improvement Rate |
75.7; 73.5; 68.6; 65.3; 69.1; 73.0 | — |
| SECONDARY Frequency of Adverse Events (Adverse Drug Reactions) |
0.69; 0.16; 0.08; 0.07; 0.04; 0.04 | — |
Summary
To evaluate the efficacy of 4-week lansoprazole (Takepron) therapy for subjective symptomatic improvement in gastroesophageal reflux disease patients with dyspepsia symptoms
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01990339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.