Trial · NCT01990339
Lansoprazole Tablets Special Drug Use Surveillance Gastroesophageal Reflux Disease With Dyspepsia Symptoms
NCT01990339, Completed, Takeda; results first posted 2014-11-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lansoprazole Tablets Special Drug Use Surveillance Gastroesophageal Reflux Disease With Dyspepsia Symptoms. Trials, record NCT01990339. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01990339
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lansoprazole Tablets Special Drug Use Surveillance Gastroesophageal Reflux Disease With Dyspepsia Symptoms
- NCT number
- NCT01990339
- Status
- Completed
- Enrollment
- 14,965 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Gastroesophageal Reflux Disease With Dyspepsia Symptoms
- Interventions
- Lansoprazole
- First posted
- 2013-11-21
- Last updated
- 2016-09-27
- Results first posted
- 2014-11-11
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Subjective Symptom Improvement Rate | Start of treatment and Week 4 | 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. | percentage of participants | NUMBER |
| SECONDARY | Frequency of Adverse Events (Adverse Drug Reactions) | 4 Weeks | 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. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Subjective Symptom Improvement Rate | Lansoprazole | Heartburn | 75.7 | percentage of participants | |
| Subjective Symptom Improvement Rate | Lansoprazole | Acid regurgitation | 73.5 | percentage of participants | |
| Subjective Symptom Improvement Rate | Lansoprazole | Postorandial fullness | 68.6 | percentage of participants | |
| Subjective Symptom Improvement Rate | Lansoprazole | Early satiety | 65.3 | percentage of participants | |
| Subjective Symptom Improvement Rate | Lansoprazole | Epigastric pain | 69.1 | percentage of participants | |
| Subjective Symptom Improvement Rate | Lansoprazole | Epigastric burning | 73.0 | percentage of participants | |
| Subjective Symptom Improvement Rate | Lansoprazole | Upper abdominal bloating | 64.8 | percentage of participants | |
| Subjective Symptom Improvement Rate | Lansoprazole | Nausea/vomiting | 66.4 | percentage of participants | |
| Subjective Symptom Improvement Rate | Lansoprazole | Belching | 61.6 | percentage of participants | |
| Frequency of Adverse Events (Adverse Drug Reactions) | Lansoprazole | Adverse drug reaction(s) | 0.69 | percentage of participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lansoprazole | 14,965 | |
| Overall Study | COMPLETED | Lansoprazole | 12,653 | |
| Overall Study | NOT COMPLETED | Lansoprazole | 2,312 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Acute abdomen | Gastrointestinal disorders | Lansoprazole | 1 | 13,514 | 1 |
| serious | Colitis ischaemic | Gastrointestinal disorders | Lansoprazole | 1 | 13,514 | 1 |
| serious | Cholecystitis | Hepatobiliary disorders | Lansoprazole | 2 | 13,514 | 2 |
| serious | Abscess limb | Infections and infestations | Lansoprazole | 1 | 13,514 | 1 |
| serious | Joint abscess | Infections and infestations | Lansoprazole | 1 | 13,514 | 1 |
| serious | Blood glucose increased | Investigations | Lansoprazole | 1 | 13,514 | 1 |
| serious | Cerebral haemorrhage | Nervous system disorders | Lansoprazole | 1 | 13,514 | 1 |
| serious | Cerebral infarction | Nervous system disorders | Lansoprazole | 1 | 13,514 | 1 |
| serious | Dizziness | Nervous system disorders | Lansoprazole | 1 | 13,514 | 1 |
| serious | Toxic skin eruption | Skin and subcutaneous tissue disorders | Lansoprazole | 1 | 13,514 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lansoprazole | ||
| Total, other adverse events | Lansoprazole | 0 | 13,514 |
| Total, serious adverse events | Lansoprazole | 10 | 13,514 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01990339
GET https://conductscience.org/api/trials/v1/NCT01990339/results?page=2