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

History of Changes

Results First Received: April 15, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, Investigator); Primary Purpose: Treatment
Condition:	Gastroesophageal Reflux Disease
Interventions:	Drug: SPD557 Drug: placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
SPD557	0.5 mg tablet administered 3 times daily (t.i.d.) for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
Placebo	Matching placebo tablet administered three times daily (t.i.d.) for 4 weeks in addition to stable PPI treatment

Participant Flow: Overall Study

	SPD557	Placebo
STARTED	34	33
COMPLETED	32	30
NOT COMPLETED	2	3
Adverse Event	1	1
Did not want second pH/MII monitoring	1	1
Not meeting inclusion/exclusion criteria	0	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Safety Population was used defined as all subjects randomized into the study with at least 1 administration of the investigational product. Two subjects never received investigational product (n = 65).

Reporting Groups

	Description
SPD557	0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
Placebo	Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
Total	Total of all reporting groups

Baseline Measures

SPD557

Placebo

Total

Overall Participants Analyzed
[Units: Participants]

Age
[Units: Years]
Mean (Standard Deviation)

43.8 (16.04)

45.8 (14.50)

44.8 (15.24)

Age, Customized
[Units: Participants]

Between 18 and 70 years inclusive

Gender
[Units: Participants]

Female

Male

Region of Enrollment ^[1]
[Units: Participants]

France

Belgium

Netherlands

Germany

United Kingdom

Switzerland

^[1]	All randomized subjects (n = 67).

Outcome Measures

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1. Primary:

Change From Baseline in the Number of Liquid-containing Reflux Events (pH/MII Monitoring) at 4 Weeks [ Time Frame: Baseline and 4 weeks ]

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2. Secondary:

Change From Baseline in the Number of Days With Heartburn and/or Regurgitation at 4 Weeks [ Time Frame: Baseline and 4 weeks ]

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3. Secondary:

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 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Results data should be interpreted with caution since the study’s early termination affects the statistical power to detect true differences between treatment groups.

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.

Results Point of Contact:

Name/Title: Study Physician
Organization: Shire Development LLC
phone: +1 866 842 5335

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT01370863 History of Changes
Other Study ID Numbers:	SPD557-202 2010-021397-12 ( EudraCT Number )
Study First Received:	May 31, 2011
Results First Received:	April 15, 2013
Last Updated:	June 25, 2014

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