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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

An Explorative, Randomized, Placebo-controlled, DB, Parallel-group Trial, to Evaluate the Pharmacodynamic Effect of SPD557 on Reflux Parameters in Subjects With GERD & With Persistent Symptoms Despite Taking a Stable Dose of PPIs

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01370863
• Other study ID #: SPD557-202
• Secondary ID: 2010-021397-12
• Status: Terminated
• Phase: Phase 2
• Start date: December 2, 2010
• Est. completion date: May 29, 2012

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: May 29, 2012
• Est. primary completion date: May 29, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

1. Written ICF signed voluntarily before the first trial related activity.

2. Subjects with a history of GERD symptoms (i.e., heartburn and/or regurgitation) during the last 6 months

3. Subjects on a stable dose of PPIs, compliant for at least 6 weeks prior to screening.

4. =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:

1. Subjects with prior endoscopic anti-reflux procedure or major GI surgery or subjects with major GI disorders.

2. Presence of severe and clinically uncontrolled cardiovascular, liver or lung disease, neurologic, cancer or AIDS.

3. Alarm symptoms suggestive of malignancies or organic disease.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• SPD557
0.5 mg tablet t.i.d. for 4 weeks on top of stable PPI treatment
• placebo
matching placebo tablet t.i.d. for 4 weeks on top of stable PPI treatment

Locations

Country	Name	City	State
Belgium	CUB Hôpital Erasme	Brussels	Bruxelles
Belgium	Cliniques universitaires Saint Luc	Bruxelles
Belgium	UZ Leuven, Belgium	Leuven
France	CHU de Bordeaux - Hôpital Saint André	Bordeaux Cedex
France	CHU de Lyon - Groupement Hospitalier Edouard Herriot	Lyon
France	Hôtel Dieu - CHU de Nantes	Nantes Cedex 1
Germany	Klinikum Garmisch-Partenkirchen GmbH	Garmisch-Partenkirchen
Germany	Otto-von-Guericke University	Magdeburg
Netherlands	Academisch Medisch Centrum (AMC)	Amsterdam
Switzerland	Inselspital Bern (Bern University Hopsital)	Bern
Switzerland	Kantonsspital St. Gallen	St. Gallen
Switzerland	University Hospital Zurich	Zurich
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	Wingate Institute of Neurogastroenterology	London
United Kingdom	Queen's Medical Center (Nottingham University Hospital)	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Number of Liquid-containing Reflux Events (pH/MII Monitoring) at 4 Weeks	This is used to characterize gastric reflux events. The measurements were made over a 24-hour period at baseline and again at week 4.	Baseline and 4 weeks
Secondary	Change From Baseline in the Number of Days With Heartburn and/or Regurgitation at 4 Weeks		Baseline and 4 weeks
Secondary	Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Questionnaire at 4 Weeks	The PAGI-SYM contains 20 items and the scores range from 0 (no symptoms)-5 (very severe symptoms) for each item with a total score of 0-100. Higher scores indicate more severe gastrointestinal symptoms.	Baseline and 4 weeks