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

NCT01370863 | Terminated Phase 2 Results

• 2 other identifiers: SPD557-2022010-021397-12
• Study Type: interventional
• Target: 67
• Locations: 6 countries
• Sites: 15

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.

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD; Gastroesophageal reflux disease; SPD557; Proton pump inhibitors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change From Baseline in the Number of Days With Heartburn and/or Regurgitation at 4 Weeks

  Baseline and 4 weeks

• Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Questionnaire at 4 Weeks

  Baseline and 4 weeks

Study Arms (2)

SPD557

EXPERIMENTAL

Drug: SPD557

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

SPD557 DRUG

0.5 mg tablet t.i.d. for 4 weeks on top of stable PPI treatment

SPD557

placebo DRUG

matching placebo tablet t.i.d. for 4 weeks on top of stable PPI treatment

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shire: lead

Study Sites (15)

CUB Hôpital Erasme

Brussels, Brussels Capital, 1070, Belgium

Location

Cliniques universitaires Saint Luc

Brussels, 1200, Belgium

Location

UZ Leuven, Belgium

Leuven, 3000, Belgium

Location

CHU de Bordeaux - Hôpital Saint André

Bordeaux, 33075, France

Location

CHU de Lyon - Groupement Hospitalier Edouard Herriot

Lyon, 69437, France

Location

Hôtel Dieu - CHU de Nantes

Nantes, 44093, France

Location

Klinikum Garmisch-Partenkirchen GmbH

Garmisch-Partenkirchen, 82467, Germany

Location

Otto-von-Guericke University

Magdeburg, 39120, Germany

Location

Academisch Medisch Centrum (AMC)

Amsterdam, 1105 AZ, Netherlands

Location

Inselspital Bern (Bern University Hopsital)

Bern, BHH D140, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

University Hospital Zurich

Zurich, CH-8091, Switzerland

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Wingate Institute of Neurogastroenterology

London, E12AJ, United Kingdom

Location

Queen's Medical Center (Nottingham University Hospital)

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 25530111 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Limitations and Caveats

Results data should be interpreted with caution since the study's early termination affects the statistical power to detect true differences between treatment groups.

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 10, 2011
• Study Start: December 2, 2010
• Primary Completion: May 29, 2012
• Study Completion: May 29, 2012
• Last Updated: June 10, 2021
• Results First Posted: June 7, 2013

Record last verified: 2021-05

Locations

CH (3); FR (3); BE (3); DE (2); GB (3); NL (1)