A Phase 2 interventional study of lesogaberan (AZD3355) and lesogaberan (AZD3355) in Gastroesophageal Reflux Disease, Heartburn and Regurgitation, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-04-25.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
This study is being carried out to see whether AZD3355 is an effective treatment as an add-on to PPI therapy in patients with Gastroesophageal Reflux Disease (GERD) with a partial response to PPI and to compare this with Proton Pump Inhibitor (PPI) treatment alone. Another goal of the study is to examine which of the investigated doses of AZD3355 is optimal for treatment of these patients. This study will also measure levels of drug in the blood and see how well it is tolerated.
1,086 studies on the registry are indexed under Gastroesophageal Reflux; 187 are open to participants now.
This study's enrollment of 661 is above the median of 72 across 724 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.
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Exclusion Criteria:
PPI+lesogaberan (AZD3355) 60 mg bid
Drug: lesogaberan (AZD3355)
PPI+lesogaberan (AZD3355) 120 mg bid
Drug: lesogaberan (AZD3355)
PPI+lesogaberan (AZD3355) 180 mg bid
Drug: lesogaberan (AZD3355)
PPI+lesogaberan (AZD3355) 240 mg bid
Drug: lesogaberan (AZD3355)
PPI+ Placebo
Drug: Placebo
60 mg, oral, capsules, bid for 4 w
120 mg, oral, capsules, bid for 4 w
180 mg, oral, capsules, bid for 4 w
240 mg, oral, capsules, bid for 4 w
oral,capsules, bid for 4 w
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)
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)
Time frame: The 7 days before randomisation (baseline) and during 26-30 days of treatment
Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms.
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)
Time frame: The 7 days before randomisation (baseline) and during 26-30 days of treatment
| Milestone | AZD3355 60 mg | AZD3355 120 mg | AZD3355 180 mg | AZD3355 240 mg | Placebo |
|---|---|---|---|---|---|
| Started | 134 | 125 | 136 | 126 | 140 |
| Completed | 121 | 109 | 114 | 114 | 122 |
| Not completed | 13 | 16 | 22 | 12 | 18 |
| Withdrew: Withdrawal by subject | 2 | 5 | 3 | 4 | 9 |
| Withdrew: Eligibility criteria not fulfilled | 4 | 0 | 4 | 1 | 0 |
| Withdrew: Adverse event | 2 | 6 | 8 | 5 | 4 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 0 | 2 |
| Withdrew: Developed study-specific withdrawal crit | 2 | 0 | 3 | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 4 | 2 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 2 |
| Withdrew: Patient moved | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Wrong drug dispensed | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Randomized in error | 0 | 0 | 1 | 1 | 0 |
| Withdrew: Lack of efficacy | 0 | 0 | 1 | 1 | 0 |
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)
| Participants | AZD3355 60 mg | AZD3355 120 mg | AZD3355 180 mg | AZD3355 240 mg | Placebo |
|---|---|---|---|---|---|
| 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) | 28 | 32 | 32 | 33 | 25 |
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)
| Percent | AZD3355 60 mg | AZD3355 120 mg | AZD3355 180 mg | AZD3355 240 mg | Placebo |
|---|---|---|---|---|---|
| Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms. | 10.7 (0 to 35.7) | 17.2 (0 to 46.4) | 11.9 (0 to 40.9) | 12.5 (0 to 47.1) | 0 (0 to 30.8) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AZD3355 60 mg | — | — | — |
| AZD3355 120 mg | — | — | — |
| AZD3355 180 mg | — | — | — |
| AZD3355 240 mg | — | — | — |
| Placebo | — | — | — |
| Event | AZD3355 60 mg | AZD3355 120 mg | AZD3355 180 mg | AZD3355 240 mg | Placebo |
|---|---|---|---|---|---|
| Non-Cardiac Chest PainGeneral disorders | 0/135 | 0/124 | 0/136 | 1/126 | 0/140 |
| Metastatic Gastric CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/135 | 0/124 | 0/136 | 0/126 | 1/140 |
| Event | AZD3355 60 mg | AZD3355 120 mg | AZD3355 180 mg | AZD3355 240 mg | Placebo |
|---|---|---|---|---|---|
| ParaesthesiaNervous system disorders | 8/135 | 5/124 | 10/136 | 11/126 | 8/140 |
| DiarrhoeaGastrointestinal disorders | 5/135 | 7/124 | 6/136 | 10/126 | 1/140 |
| Age Continuous(years) | AZD3355 60 mg | AZD3355 120 mg | AZD3355 180 mg | AZD3355 240 mg | Placebo | Total |
|---|---|---|---|---|---|---|
| Mean | 47.4 ± 12.3 | 46.1 ± 13.5 | 48.0 ± 12.3 | 48.5 ± 12.1 | 48.3 ± 12.0 | 47.7 ± 12.4 |
| Sex: Female, Male(Participants) | AZD3355 60 mg | AZD3355 120 mg | AZD3355 180 mg | AZD3355 240 mg | Placebo | Total |
|---|---|---|---|---|---|---|
| Female | 84 | 75 | 75 | 75 | 67 | 376 |
| Male | 50 | 50 | 61 | 51 | 73 | 285 |
The record gives a start of Oct 2009, a primary completion of Jul 2010 and a completion of Jul 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2011, 9 months after primary completion.
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This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lesogaberan