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

This study has been terminated.
(This study was terminated early due to recruitment difficulties. There were no safety concerns.)
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01370863
First received: May 31, 2011
Last updated: June 25, 2014
Last verified: April 2014

May 31, 2011
June 25, 2014
December 2010
May 2012   (final data collection date for primary outcome measure)
Change From Baseline in the Number of Liquid-containing Reflux Events (pH/MII Monitoring) at 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
This is used to characterize gastric reflux events. The measurements were made over a 24-hour period at baseline and again at week 4.
24-h pH/MII monitoring (pre- and post- treatment) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01370863 on ClinicalTrials.gov Archive Site
  • Change From Baseline in the Number of Days With Heartburn and/or Regurgitation at 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Questionnaire at 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.
  • Daily diary symptom scores for heartburn and regurgitation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Pagi-Sym questionnaire [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
An Explorative Trial to Evaluate the Pharmacodynamic Effect of SPD557 on Reflux Parameters in Refractory GERD Patients
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Gastroesophageal Reflux Disease
  • Drug: SPD557
    0.5 mg tablet t.i.d. for 4 weeks on top of stable PPI treatment
  • Drug: placebo
    matching placebo tablet t.i.d. for 4 weeks on top of stable PPI treatment
  • Experimental: SPD557
    Intervention: Drug: SPD557
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
67
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Germany,   Netherlands,   Switzerland,   United Kingdom
 
NCT01370863
SPD557-202, 2010-021397-12
No
Shire
Shire
Not Provided
Study Director: An Rykx, PhD Shire-Movetis
Principal Investigator: Prof. Jan Tack, M.D. KUL, Herestraat 49, 3000 Leuven
Shire
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP