Trial · NCT01005251
Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI
NCT01005251, Phase 2, Completed, AstraZeneca; results first posted 2011-04-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI. Trials, record NCT01005251. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01005251
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI
- NCT number
- NCT01005251
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 661 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Gastroesophageal Reflux Disease, Heartburn, Regurgitation
- Interventions
- lesogaberan (AZD3355), lesogaberan (AZD3355), lesogaberan (AZD3355), lesogaberan (AZD3355), Placebo
- First posted
- 2009-10-30
- Last updated
- 2011-04-25
- Results first posted
- 2011-04-25
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation) | The 7 days before randomisation (baseline) and during 26-30 days of treatment | Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary. (GERD = Gastroesophageal Reflux Disease) |
| Secondary | Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms. | The 7 days before randomisation (baseline) and during 26-30 days of treatment | Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary (GERD = Gastroesophageal Reflux Disease) |
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 | Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation) | The 7 days before randomisation (baseline) and during 26-30 days of treatment | Participants | NUMBER | |
| SECONDARY | Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms. | The 7 days before randomisation (baseline) and during 26-30 days of treatment | Percent | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation) | AZD3355 60 mg | 28 | Participants | ||
Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation) | AZD3355 120 mg | 32 | Participants | ||
Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation) | AZD3355 180 mg | 32 | Participants | ||
Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation) | AZD3355 240 mg | 33 | Participants | ||
Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation) | Placebo | 25 | Participants | ||
| Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms. | AZD3355 60 mg | 10.7 | Inter-Quartile Range 0 to 35.7 | Percent | |
| Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms. | AZD3355 120 mg | 17.2 | Inter-Quartile Range 0 to 46.4 | Percent | |
| Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms. | AZD3355 180 mg | 11.9 | Inter-Quartile Range 0 to 40.9 | Percent | |
| Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms. | AZD3355 240 mg | 12.5 | Inter-Quartile Range 0 to 47.1 | Percent | |
| Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms. | Placebo | 0 | Inter-Quartile Range 0 to 30.8 | Percent |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AZD3355 60 mg | 134 | |
| Overall Study | STARTED | AZD3355 120 mg | 125 | |
| Overall Study | STARTED | AZD3355 180 mg | 136 | |
| Overall Study | STARTED | AZD3355 240 mg | 126 | |
| Overall Study | STARTED | Placebo | 140 | |
| Overall Study | COMPLETED | AZD3355 60 mg | 121 | |
| Overall Study | COMPLETED | AZD3355 120 mg | 109 | |
| Overall Study | COMPLETED | AZD3355 180 mg | 114 | |
| Overall Study | COMPLETED | AZD3355 240 mg | 114 | |
| Overall Study | COMPLETED | Placebo | 122 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events20
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 |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | AZD3355 60 mg | 5 | 135 | |
| other | Diarrhoea | Gastrointestinal disorders | AZD3355 120 mg | 7 | 124 | |
| other | Diarrhoea | Gastrointestinal disorders | AZD3355 180 mg | 6 | 136 | |
| other | Diarrhoea | Gastrointestinal disorders | AZD3355 240 mg | 10 | 126 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 140 | |
| other | Paraesthesia | Nervous system disorders | AZD3355 60 mg | 8 | 135 | |
| other | Paraesthesia | Nervous system disorders | AZD3355 120 mg | 5 | 124 | |
| other | Paraesthesia | Nervous system disorders | AZD3355 180 mg | 10 | 136 | |
| other | Paraesthesia | Nervous system disorders | AZD3355 240 mg | 11 | 126 | |
| other | Paraesthesia | Nervous system disorders | Placebo | 8 | 140 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AZD3355 60 mg | ||
| Total, all-cause mortality | AZD3355 120 mg | ||
| Total, all-cause mortality | AZD3355 180 mg | ||
| Total, all-cause mortality | AZD3355 240 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | AZD3355 60 mg | 13 | |
| Total, other adverse events | AZD3355 120 mg | 12 | |
| Total, other adverse events | AZD3355 180 mg | 16 | |
| Total, other adverse events | AZD3355 240 mg | 20 | |
| Total, other adverse events | Placebo | 9 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT01005251
GET https://conductscience.org/api/trials/v1/NCT01005251/registered