TerminatedPhase 2

An Explorative Trial to Evaluate the Pharmacodynamic Effect of SPD557 on Reflux Parameters in Refractory GERD Patients

Stopped: This study was terminated early due to recruitment difficulties. There were no safety concerns.

Belgium, France67 participantsStarted 2010-12-02

Plain-language summary

The purpose of this trial is to investigate the pharmacodynamic effect on reflux parameters of SPD557 tablets (0.5 mg t.i.d., on top of PPI treatment) in patients with Gastroesophageal Reflux Disease (GERD) with persistent symptoms despite taking a stable dose of proton pump inhibitors. Additionally the effect on symptoms will be explored and safety and tolerability will be evaluated.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Written ICF signed voluntarily before the first trial related activity.
✓. Subjects with a history of GERD symptoms (i.e., heartburn and/or regurgitation) during the last 6 months
✓. Subjects on a stable dose of PPIs, compliant for at least 6 weeks prior to screening.
✓. ≥3 days per week with heartburn and/or regurgitation symptoms of at least moderate severity and a minimum of 25 liquid containing reflux events over 24h (pH/MII monitoring).

Exclusion criteria

✕. Subjects with prior endoscopic anti-reflux procedure or major GI surgery or subjects with major GI disorders.
✕. Presence of severe and clinically uncontrolled cardiovascular, liver or lung disease, neurologic, cancer or AIDS.
✕. Alarm symptoms suggestive of malignancies or organic disease.

What they're measuring

Change From Baseline in the Number of Liquid-containing Reflux Events (pH/MII Monitoring) at 4 Weeks

Timeframe: Baseline and 4 weeks

Trial details

NCT IDNCT01370863

SponsorShire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-05-29

Results submitted2013-04-15

View on ClinicalTrials.gov More Gastroesophageal Reflux Disease trials