Effects of new prokinetic drug for patients on stable PPI dose

• Research type

  Research Study

• Full title

  An explorative, randomized, placebo-controlled, double blind, parallel group trial, to evaluate the pharmacodynamic effect of M0003 on reflux parameters in subjects with gastroesophageal reflux disease and with persistent symptoms despite taking a stable dose of proton pump inhibitors.

• IRAS ID

  63778

• Contact name

  Daniel A Sifrim

• Sponsor organisation

  Movetis N.V.

• Eudract number

  2010-021397-12

• ISRCTN Number

  N/A

• Research summary

  This is a Phase IIa explorative, multicentre, randomized, placebo-controlled, double-blind, parallel-group trial in GERD patients refractory to PPI treatment, to explore the effects of the prokinetic M0003 on flu events (primarily) and on symptoms (secondarily) and to evaluate the safety and tolerability. . Subjects will be randomized (1:1) to receive M0003 tablets (0.5 mg t.i.d.) or matching placebo tablets (t.i.d.) on top of their stable PPI treatment. The treatment period will be 4 weeks preceded by a run-in period of 14 days. In case the subject is taking prohibited concomitant medication, a potential 7-day wash-out will be scheduled prior to run-in. At most, 6 visits will be scheduled for each subject, with a minimal duration of 43 days for the entire trial. A 24-h pH/MII monitoring will be performed to establish the flu pattern on Visit 2 (at baseline and for eligibility) and on Visit 5 (at 4 weeks on treatment). Patients will complete an electronic diary twice daily from Visit 1 (screening) until the end of the study to monitor severity and frequency of heartburn and regurgitation (for eligibility and for effects on symptoms) and fluence on sleep. The diary will also check compliance of PPI and trial medication intake, and will document the need for rescue medication. Symptoms and quality of life will be assessed by 2 validated self-assessment scales (PAGI-SYM and PAGI-QOL, resp.) prior to and on treatment. Safety will be assessed by adverse events (AE) recordings (from signing the informed consent onwards until the final visit or until resolution of the AE) , clinical laboratory tests (biochemistry, haematology, urinalysis), physical examinations, ECG recordings, vital signs and concomitant therapy recordings. At Visit 5, a pre-dose blood sample will be taken to establish trough levels.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  10/H0806/114

• Date of REC Opinion

  16 Mar 2011

• REC opinion

  Further Information Favourable Opinion