Zegerid® vs. Losec® in the rapid relief of heartburn associated with G

• Research type

  Research Study

• Full title

  A double-blind, double-dummy, randomised, study to assess the superiority of Zegerid® 20 mg vs. Losec® 20 mg in the rapid relief of heartburn associated with GERD as on demand therapy.

• IRAS ID

  70469

• Contact name

  Tim Hall

• Sponsor organisation

  Norgine Ltd

• Eudract number

  2010-022082-10

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Heartburn is the hallmark symptom for gastroesophageal reflux disease (GERD), and when accompanied with acid regurgitation and other symptoms, has a significant negative impact on a patients' quality of life. Although various medications are currently available, they frequently fail to completely resolve symptoms. This study aims to demonstrate that symptoms of heartburn associated with GERD are resolved earlier in patients given immediate-release Zegerid© when compared with delayed-release Losec©. Eligible patients will be randomised into two groups, which will be given either Zegerid© 20 mg or Losec© 20 mg. Neither the patient nor the doctor will know which medication the patient has been allocated to receive. Both group will also be given Gaviscon© to be taken when required. Approximately 300 patients will be asked to participate in this study from 50 centres across 6 EU countries. They will be involved in the study for a maximum of 21 days during which time they will attend the research site for 3 visits. Throughout the study patients will record the severity and frequency of heartburn episodes in a patient diary.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  11/H0717/5

• Date of REC Opinion

  9 Feb 2011

• REC opinion

  Favourable Opinion