Trial · NCT01135368

Safety and Efficacy of Lansoprazole in Patients With Reflux Disease

NCT01135368, Phase 4, Completed, Takeda; results first posted 2012-09-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Lansoprazole in Patients With Reflux Disease. Trials, record NCT01135368. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01135368

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Lansoprazole in Patients With Reflux Disease
NCT number: NCT01135368
Status: Completed
Phases: Phase 4
Enrollment: 506 participants, actual
Lead sponsor: Takeda
Conditions: Gastroesophageal Reflux
Interventions: Lansoprazole
First posted: 2010-06-02
Last updated: 2012-09-03
Results first posted: 2012-09-03

Source ClinicalTrials.gov

Registered outcomes36

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Reflux Disease Symptom - Heartburn	Baseline and Week 8	Heartburn symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.
Primary	Change From Baseline in Reflux Disease Symptoms - Acid Regurgitation	Baseline and Week 8	Acid regurgitation symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.
Primary	Change From Baseline in Reflux Disease Symptom - Difficulty Swallowing	Baseline and Week 8	Difficulty swallowing symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.
Primary	Change From Baseline in Reflux Disease Symptom - Pain in Upper Abdomen	Baseline and Week 8	Pain in the upper abdomen symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.
Primary	Change From Baseline in Reflux Disease Symptom - Nausea & Vomiting	Baseline and Week 8	Nausea and vomiting symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.
Primary	Change From Baseline in Reflux Disease Symptom - Cough & Sore Throat	Baseline and Week 8	Cough and sore throat symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.
Primary	Change From Baseline in Endoscopic Healing of Erosive Reflux Disease as Assessed by Endoscopy	Baseline and Week 8	Los Angeles Classification is used to grade the extension of changes in the oesophagus induced by reflux disease (Grade 0: normal aspect of mucosa; Grade A: ≥1 mucosal breaks no longer than 5 mm; Grade B: ≥1 mucosal breaks \>5 mm long; Grade C: mucosal breaks extending between tops of two or more mucosal folds but are \<75% of the circumference; Grade D: mucosal breaks ≥75% of the circumference). Healed defined as anything less than Grade A criteria. The shift table below summarizes the individual transitions in Los Angeles classification between Baseline (table columns) and Week 8 (table rows).
Secondary	Change From Baseline in Enterochromaffin-like Cell Hyperplasia	Baseline and Year 5	Enterochromaffin-like (ECL) cells were evaluated and classified by histopathological examinations as Normal, Simple (diffuse) hyperplasia, or Linear, chain producing hyperplasia. The shift table below summarizes the individual transitions in ECL-cell classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows) for all patients.
Secondary	Change From Baseline in Antrum Atrophy	Baseline and Year 5	Atrophy was assessed by histopathological examination of cells biopsied from the antrum and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in atrophy classification (mild, moderate, severe or none) between Baseline (depicted in the columns) and Year 5 (depicted in the rows).
Secondary	Change From Baseline in Corpus Atrophy	Baseline and Year 5	Atrophy was assessed by histopathological examination of cells biopsied from the corpus and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in atrophy classification (mild, moderate, severe or none) between Baseline (depicted in the columns) and Year 5 (depicted in the rows).

1 to 10 of 36Source ClinicalTrials.gov

See all 36 registered outcomes

Outcomes36

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Reflux Disease Symptom - Heartburn	Baseline and Week 8	Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.	participants	NUMBER
PRIMARY	Change From Baseline in Reflux Disease Symptoms - Acid Regurgitation	Baseline and Week 8	Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.	participants	NUMBER
PRIMARY	Change From Baseline in Reflux Disease Symptom - Difficulty Swallowing	Baseline and Week 8	Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.	participants	NUMBER
PRIMARY	Change From Baseline in Reflux Disease Symptom - Pain in Upper Abdomen	Baseline and Week 8	Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.	participants	NUMBER
PRIMARY	Change From Baseline in Reflux Disease Symptom - Nausea & Vomiting	Baseline and Week 8	Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.	participants	NUMBER
PRIMARY	Change From Baseline in Reflux Disease Symptom - Cough & Sore Throat	Baseline and Week 8	Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.	participants	NUMBER
PRIMARY	Change From Baseline in Endoscopic Healing of Erosive Reflux Disease as Assessed by Endoscopy	Baseline and Week 8	Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.	participants	NUMBER
SECONDARY	Change From Baseline in Enterochromaffin-like Cell Hyperplasia	Baseline and Year 5	Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.	participants	NUMBER
SECONDARY	Change From Baseline in Antrum Atrophy	Baseline and Year 5	Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.	participants	NUMBER
SECONDARY	Change From Baseline in Corpus Atrophy	Baseline and Year 5	Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.	participants	NUMBER

1 to 10 of 36Source ClinicalTrials.gov

See all 36 outcomes

Results by group421

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Change From Baseline in Reflux Disease Symptom - Heartburn	Mild	Week 8 Symptoms: None	59	participants
Change From Baseline in Reflux Disease Symptom - Heartburn	Moderate	Week 8 Symptoms: None	117	participants
Change From Baseline in Reflux Disease Symptom - Heartburn	Severe	Week 8 Symptoms: None	186	participants
Change From Baseline in Reflux Disease Symptom - Heartburn	Mild	Week 8 Symptoms: Mild	7	participants
Change From Baseline in Reflux Disease Symptom - Heartburn	Moderate	Week 8 Symptoms: Mild	27	participants
Change From Baseline in Reflux Disease Symptom - Heartburn	Severe	Week 8 Symptoms: Mild	43	participants
Change From Baseline in Reflux Disease Symptom - Heartburn	Mild	Week 8 Symptoms: Moderate	0	participants
Change From Baseline in Reflux Disease Symptom - Heartburn	Moderate	Week 8 Symptoms: Moderate	4	participants
Change From Baseline in Reflux Disease Symptom - Heartburn	Severe	Week 8 Symptoms: Moderate	12	participants
Change From Baseline in Reflux Disease Symptom - Heartburn	Mild	Week 8 Symptoms: Severe	0	participants

1 to 10 of 421Source ClinicalTrials.gov

See all 421 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lansoprazole	506
Overall Study	COMPLETED	Lansoprazole	255
Overall Study	NOT COMPLETED	Lansoprazole	251

Source ClinicalTrials.gov

Adverse events107

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
other	Bronchitis	Infections and infestations	Lansoprazole	46	506
other	Hypertension	Vascular disorders	Lansoprazole	30	506
other	Back pain	Musculoskeletal and connective tissue disorders	Lansoprazole	29	506
other	Diarrhoea	Gastrointestinal disorders	Lansoprazole	28	506
serious	Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Lansoprazole	2	506
serious	Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Lansoprazole	2	506
serious	Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Lansoprazole	2	506
serious	Astrocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Lansoprazole	1	506
serious	Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Lansoprazole	1	506
serious	Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Lansoprazole	1	506

1 to 10 of 107Source ClinicalTrials.gov

See all 107 adverse events

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	114	506
Total, serious adverse events	Lansoprazole	82	506

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01135368

GET https://conductscience.org/api/trials/v1/NCT01135368/registered?page=2

API reference For AI assistants