Trial Outcomes & Findings for Lansoprazole Tablets Special Drug Use Surveillance Gastroesophageal Reflux Disease With Dyspepsia Symptoms (NCT NCT01990339)
NCT ID: NCT01990339
Last Updated: 2016-09-27
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
14965 participants
Primary outcome timeframe
Start of treatment and Week 4
Results posted on
2016-09-27
Participant Flow
Participants were enrolled in the study during the period between December 8, 2008 and June 30, 2010.
Participants enrolled in the study were clinically diagnosed with reflux esophagitis or non-erosive gastroesophageal reflux disease.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
14965
|
|
Overall Study
COMPLETED
|
12653
|
|
Overall Study
NOT COMPLETED
|
2312
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Data Not Available
|
49
|
|
Overall Study
Voluntary Withdrawal
|
1402
|
|
Overall Study
Lost to Follow-up
|
861
|
Baseline Characteristics
Lansoprazole Tablets Special Drug Use Surveillance Gastroesophageal Reflux Disease With Dyspepsia Symptoms
Baseline characteristics by cohort
| Measure |
Lansoprazole
n=12653 Participants
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.
|
|---|---|
|
Age, Customized
< 65 years
|
6691 participants
n=39 Participants
|
|
Age, Customized
≥ 65 years
|
5962 participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
7417 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
5236 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12653 participants
n=39 Participants
|
|
Region of Enrollment
Japan
|
12653 participants
n=39 Participants
|
|
Body Mass Index (BMI)
BMI < 25 kg/m^2
|
6043 participants
n=39 Participants
|
|
Body Mass Index (BMI)
BMI ≥ 25 kg/m^2 and < 30 kg/m^2
|
3083 participants
n=39 Participants
|
|
Body Mass Index (BMI)
BMI ≥ 30 kg/m^2
|
472 participants
n=39 Participants
|
|
Body Mass Index (BMI)
BMI Unknown
|
3055 participants
n=39 Participants
|
|
History of Gastroesophageal Reflux Disease
Initial
|
7128 participants
n=39 Participants
|
|
History of Gastroesophageal Reflux Disease
Recurrence
|
2498 participants
n=39 Participants
|
|
History of Gastroesophageal Reflux Disease
Unknown
|
3027 participants
n=39 Participants
|
|
Duration of Dyspeptic Symptoms
< 1 month
|
5832 participants
n=39 Participants
|
|
Duration of Dyspeptic Symptoms
> 1 month and ≤ 3 months
|
3080 participants
n=39 Participants
|
|
Duration of Dyspeptic Symptoms
> 3 months and ≤ 6 months
|
802 participants
n=39 Participants
|
|
Duration of Dyspeptic Symptoms
> 6 months
|
1442 participants
n=39 Participants
|
|
Duration of Dyspeptic Symptoms
Unknown
|
1497 participants
n=39 Participants
|
|
Marked Kyphosis
No
|
12148 participants
n=39 Participants
|
|
Marked Kyphosis
Yes
|
505 participants
n=39 Participants
|
|
Helicobacter pylori (H. pylori) Infection at the Start of Takepron Treatment
Negative
|
2214 participants
n=39 Participants
|
|
Helicobacter pylori (H. pylori) Infection at the Start of Takepron Treatment
Positive
|
689 participants
n=39 Participants
|
|
Helicobacter pylori (H. pylori) Infection at the Start of Takepron Treatment
Unknown
|
9750 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Start of treatment and Week 4Population: 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.
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.
Outcome measures
| Measure |
Lansoprazole
n=12653 Participants
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.
|
|---|---|
|
Subjective Symptom Improvement Rate
Heartburn
|
75.7 percentage of participants
|
|
Subjective Symptom Improvement Rate
Acid regurgitation
|
73.5 percentage of participants
|
|
Subjective Symptom Improvement Rate
Postorandial fullness
|
68.6 percentage of participants
|
|
Subjective Symptom Improvement Rate
Early satiety
|
65.3 percentage of participants
|
|
Subjective Symptom Improvement Rate
Epigastric pain
|
69.1 percentage of participants
|
|
Subjective Symptom Improvement Rate
Epigastric burning
|
73.0 percentage of participants
|
|
Subjective Symptom Improvement Rate
Upper abdominal bloating
|
64.8 percentage of participants
|
|
Subjective Symptom Improvement Rate
Nausea/vomiting
|
66.4 percentage of participants
|
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Subjective Symptom Improvement Rate
Belching
|
61.6 percentage of participants
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: 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.
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.
Outcome measures
| Measure |
Lansoprazole
n=13514 Participants
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.
|
|---|---|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Adverse drug reaction(s)
|
0.69 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Diarrhoea
|
0.16 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Urticaria
|
0.08 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Rash
|
0.07 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Constipation
|
0.04 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Nausea
|
0.04 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Abdominal distension
|
0.02 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Stomatitis
|
0.02 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Dizziness
|
0.02 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Dysgeusia
|
0.02 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Headache
|
0.02 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Drug eruption
|
0.02 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Feeling abnormal
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Hypoaesthesia
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Somnolence
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Dyspnoea
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Oropharyngeal discomfort
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Pruritus
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Pruritus generalised
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Palpitations
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Abdominal pain
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Abdominal pain lower
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Change of bowel habit
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Meteorism
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Gastrooesophageal reflux disease
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Oral discomfort
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Oral mucosal eruption
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Abdominal discomfort
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Chest pain
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Face oedema
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Oedema
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Thirst
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Decreased appetite
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Back pain
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Sleep disorder
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Cough
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Acne
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Eczema
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Erythema multiforme
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Toxic skin eruption
|
0.01 percentage of participants
|
|
Frequency of Adverse Events (Adverse Drug Reactions)
Hot flush
|
0.01 percentage of participants
|
Adverse Events
Lansoprazole
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lansoprazole
n=13514 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Acute abdomen
|
0.01%
1/13514 • Number of events 1 • 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
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.01%
1/13514 • Number of events 1 • 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
|
|
Hepatobiliary disorders
Cholecystitis
|
0.01%
2/13514 • Number of events 2 • 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
|
|
Infections and infestations
Abscess limb
|
0.01%
1/13514 • Number of events 1 • 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
|
|
Infections and infestations
Joint abscess
|
0.01%
1/13514 • Number of events 1 • 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
|
|
Investigations
Blood glucose increased
|
0.01%
1/13514 • Number of events 1 • 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
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.01%
1/13514 • Number of events 1 • 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
|
|
Nervous system disorders
Cerebral infarction
|
0.01%
1/13514 • Number of events 1 • 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
|
|
Nervous system disorders
Dizziness
|
0.01%
1/13514 • Number of events 1 • 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
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.01%
1/13514 • Number of events 1 • 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
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER