A Phase 2 interventional study of AZD3355 in Gastroesophageal Reflux Disease (GERD), sponsored by AstraZeneca. Completed at 38 sites in 8 countries. Open to participants aged 17 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-03-18.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
The purpose of this study is to estimate the effect of AZD3355 as an add-on treatment to a Proton Pump Inhibitor (PPI) on Gastroesophageal reflux disease (GERD) symptoms in patients with an incomplete response to PPI treatment.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 244 is above the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Also known as: Lesogaberan
Number of Participants With at Most One Day With Not More Than Mild Intensity of the Symptoms 'a Burning Feeling Behind the Breastbone' and 'Unpleasant Movement of Material Upwards From the Stomach' During the Last Seven 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 Disease Questionnaire (RDQ) diary
Time frame: Twice daily during the last seven days on treatment
Plasma Concentration (µmol/L) of AZD3355 Analysed From Blood Sample Taken in the Interval One to Two Hours After the First Intake of AZD3355 65 mg Capsule
Time frame: An interval of one to two hours after the first intake of AZD3355 65 mg capsule
| Milestone | AZD3355 | Placebo |
|---|---|---|
| Started | 122 | 122 |
| Completed | 113 | 111 |
| Not completed | 9 | 11 |
| Withdrew: Protocol violation | 1 | 3 |
| Withdrew: Incorrect enrolment | 4 | 2 |
| Withdrew: Adverse event | 4 | 2 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
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 Disease Questionnaire (RDQ) diary
| Participants | AZD3355 | Placebo |
|---|---|---|
| Number of Participants With at Most One Day With Not More Than Mild Intensity of the Symptoms 'a Burning Feeling Behind the Breastbone' and 'Unpleasant Movement of Material Upwards From the Stomach' During the Last Seven Days of Treatment | 17 | 8 |
| μmol/L | AZD3355 | Placebo |
|---|---|---|
| Plasma Concentration (µmol/L) of AZD3355 Analysed From Blood Sample Taken in the Interval One to Two Hours After the First Intake of AZD3355 65 mg Capsule | 0.96 ± 0.74 | — |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AZD3355 | — | — | — |
| Placebo | — | — | — |
| Event | AZD3355 | Placebo |
|---|---|---|
| HypertensionVascular disorders | 1/122 | 0/122 |
| AppendicitisInfections and infestations | 1/122 | 0/122 |
| Event | AZD3355 | Placebo |
|---|---|---|
| DIARRHOEAGastrointestinal disorders | 13/122 | 4/122 |
| PARAESTHESIANervous system disorders | 10/122 | 6/122 |
| NAUSEAGastrointestinal disorders | 9/122 | 4/122 |
| FATIGUEGeneral disorders | 7/122 | 7/122 |
| Age Continuous(years) | AZD3355 | Placebo | Total |
|---|---|---|---|
| Mean | 51.1 ± 11.9 | 48.7 ± 12.6 | 49.9 ± 12.3 |
| Sex: Female, Male(Participants) | AZD3355 | Placebo | Total |
|---|---|---|---|
| Female | 51 | 31 | 82 |
| Male | 71 | 91 | 162 |
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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