Gastroesophageal Reflux Disease (GERD) MedDRA version: 8.1 Level: LLT Classification code 10017924 Term: Gastroesophageal reflux
Conditions
Interventions
Product Name: AZD3355
Product Code: AZD3355
Pharmaceutical Form: Capsule, hard
CAS Number: 344413-67-8
Current Sponsor code: AZD3355
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent 2. Male or female (females must be post-menopausal, ((i.e >12 months without a menstrual period and > 50 years of age)) or be bilaterally oophorectomized or hysterectomized 3. Age 18-70 years 4. Weight 60-100 kg 5. At least 6 months history of GERD symptoms (need not to be consecutive) and a history of an incomplete response to PPI treatment 6. Continuously treated with an approved dose of any PPI during at least 6 weeks before enrolment 7. Ability to read and write and to use the e-diary 8. Screening questionnaire (RDQ) indicating a burning feeling behind the breastbone with a frequency of at least 3 days over the past 7 days and with at least mild intensity and/or unpleasant movement of material upwards from the stomach with a frequency of at least 3 days over the past 7 days and with at least mild intensity Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Screening questionnaire (RDQ) indicating a equal or higher intensity of pain in the centre of the upper stomach than for a burning feeling behind the breastbone, if not fulfilling the inclusion criteria regarding unpleasant movement of material upwards from the stomach. 2. History of clinically significant cardiovascular, respiratory, renal, hepatic, neurological, mental or gastrointestinal (excluding GERD) disease. Patients with uncomplicated and well controlled Diabetes Mellitus and patients with uncomplicated and well controlled hypertension (SBP =160 mmHg and DBP =90 mmHg) can be included. 3. S-creatinine >1.2 times upper limit of normal (based on laboratory results from visit 1) 4. History of clinically significant orthostatic reactions 5. Systolic blood pressure below 110 mmHg 6. History of heart disease (eg, ischemic heart disease, congestive heart failure, cardiac arrhythmias) or signs or symptoms of heart disease including QTc >480 ms or other ECG abnormalities 7. Prior surgery of the upper GI tract (open, endoscopic and laparoscopic surgery on the esophagus, the stomach and the duodenum with the exception of oversewing or endoscopic treatment of an bleeding ulcer). 8. History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensivity 9. Need for concomitant medication with - Drugs that may interfere with the pharmacodynamic effect of Investigational Product (eg, baclofen) - Drugs that may influence gastrointestinal symptoms, (eg, H2 receptor antagonists, sucralphate, alginates, tegaserod, metoclopamid, drugs with significant anticholinergic effect, non-steroid anti-inflammatory drugs (NSAIDs), cyclo-oxygenase-2 (COX-2) inhibitors, acetylsalicylic acid (ASA) >160 mg, biphosphonates, antineoplastic drugs) with exception of the PPI and antacids used in the study - Drugs that have a narrow therapeutic window (eg warfarin, digoxin, phenytoin, karbamazepin) - Drugs that may prolong the QT interval (see supplement for common examples) 10. History of drug addiction, alcohol abuse or other circumstances which in the investigators judgement may compromise the patient’s ability to comply with the study requirements 11. Any other condition which in the opinion of the investigator would render the patient unsuitable for inclusion in the study 12. Blood donation within 4 weeks prior to administration of the first dose of the investigational product 13. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site) 14. Administration of any investigational product or participation in any clinical study within 8 weeks prior to administration of the first dose of the investigational product 15. Previous enrolment or randomization of treatment in the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the effect of AZD3355 65 mg twice daily (bid) as add-on treatment to a Proton Pump Inhibitor (PPI) on GERD symptoms in patients with an incomplete response to PPI treatment with respect to improvement of each of the patient reported symptoms: - a burning feeling behind the breastbone (heartburn) - unpleasant movement of material upwards from the stomach (regurgitation) ;Secondary Objective: · To explore the effect of AZD3355 in patients with GERD symptoms and an incomplete response to PPI treatment with respect to additional patient reported symptoms · To estimate the effect of AZD3355 in patients with GERD symptoms and an incomplete response to PPI treatment with respect to consumption of antacids · To assess the pharmacokinetics of AZD3355 in patients with GERD symptoms · To assess the safety and tolerability during 4 weeks treatment with AZD3355 in patients with GERD symptoms and an incomplete response to PPI treatment · To explore the incidence of and the patients’ perception of paresthesiae and conditions with impaired wakefulness/alertness during 4 weeks treatment with AZD3355 · To explore the relationship between patient reported symptoms and perceived overall treatment effect, symptom control and treatment satisfaction, respectively ;Primary end point(s): For the Reflux Disease Questionnaire (RDQ) item(s) a burning feeling behind the breastbone and unpleasant movement of material upwards from the stomach, separately and in combination: - Number of days without symptom(s) - Maximum intensity during each week | — |
Countries
Belgium, France, Germany, Hungary, Netherlands, Norway
Outcome results
None listed