Clinical trial NCT01370863: An Explorative Trial to Evaluate the Pharmacodynamic Effect of SPD557 on Reflux Parameters in Refractory GERD Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
Gastroesophageal reflux disease
SPD557
Proton pump inhibitors
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-06-10
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in the Number of Liquid-containing Reflux Events (pH/MII Monitoring) at 4 Weeks
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change From Baseline in the Number of Days With Heartburn and/or Regurgitation at 4 Weeks
timeFrame: Baseline and 4 weeks
measure: Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Questionnaire at 4 Weeks
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CUB Hôpital Erasme
state: Bruxelles
city: Bruxelles
country: Belgium
facility: Cliniques universitaires Saint Luc
city: Leuven
country: Belgium
facility: UZ Leuven, Belgium
city: Bordeaux Cedex
country: France
facility: CHU de Bordeaux - Hôpital Saint André
city: Lyon
country: France
facility: CHU de Lyon - Groupement Hospitalier Edouard Herriot
city: Nantes Cedex 1
country: France
facility: Hôtel Dieu - CHU de Nantes
city: Garmisch-Partenkirchen
country: Germany
facility: Klinikum Garmisch-Partenkirchen GmbH
city: Magdeburg
country: Germany
facility: Otto-von-Guericke University
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum (AMC)
city: Bern
country: Switzerland
facility: Inselspital Bern (Bern University Hopsital)
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Zurich
country: Switzerland
facility: University Hospital Zurich
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: London
country: United Kingdom
facility: Wingate Institute of Neurogastroenterology
city: Nottingham
country: United Kingdom
facility: Queen's Medical Center (Nottingham University Hospital)
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Tack J, Zerbib F, Blondeau K, des Varannes SB, Piessevaux H, Borovicka J, Mion F, Fox M, Bredenoord AJ, Louis H, Dedrie S, Hoppenbrouwers M, Meulemans A, Rykx A, Thielemans L, Ruth M. Randomized clinical trial: effect of the 5-HT4 receptor agonist revexepride on reflux parameters in patients with persistent reflux symptoms despite PPI treatment. Neurogastroenterol Motil. 2015 Feb;27(2):258-68. doi: 10.1111/nmo.12484. Epub 2014 Dec 21.