Gastroesophageal Reflux DiseasePhase 2NCT01370863
An Explorative Trial to Evaluate the Pharmacodynamic Effect of SPD557 on Reflux Parameters in Refractory GERD Patients
A Phase 2 study testing SPD557 in people with Gastroesophageal Reflux Disease, run by Shire at 15 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- SPD557
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 15 sitesin 6 countries
- Study dates
- 2 Dec 2010to 29 May 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
Belgium3 sites
CUB Hôpital Erasme
Brussels, Brussels Capital, 1070
Cliniques universitaires Saint Luc
Brussels, 1200
UZ Leuven, Belgium
Leuven, 3000
France3 sites
CHU de Bordeaux - Hôpital Saint André
Bordeaux, 33075
CHU de Lyon - Groupement Hospitalier Edouard Herriot
Lyon, 69437
Hôtel Dieu - CHU de Nantes
Nantes, 44093
Switzerland3 sites
Inselspital Bern (Bern University Hopsital)
Bern, BHH D140
Kantonsspital St. Gallen
Sankt Gallen, 9007
University Hospital Zurich
Zurich, CH-8091
United Kingdom3 sites
Addenbrooke's Hospital
Cambridge, CB2 0QQ
Wingate Institute of Neurogastroenterology
London, E12AJ
Queen's Medical Center (Nottingham University Hospital)
Nottingham, NG7 2UH
Germany2 sites
Klinikum Garmisch-Partenkirchen GmbH
Garmisch-Partenkirchen, 82467
Otto-von-Guericke University
Magdeburg, 39120
About this study
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
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
- Being tested
- SPD557, placebo
- Keywords
- GERD, Gastroesophageal reflux disease, SPD557, Proton pump inhibitors
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPD557Drug
0.5 mg tablet t.i.d. for 4 weeks on top of stable PPI treatment
placeboDrug
matching placebo tablet t.i.d. for 4 weeks on top of stable PPI treatment
| Study group | Role | What they receive |
|---|---|---|
| SPD557 | Experimental | Not described Receives: Drug: SPD557 |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 weeks
Secondary outcomes (2)
Change From Baseline in the Number of Days With Heartburn and/or Regurgitation at 4 Weeks
Measured: Baseline and 4 weeks
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.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study start2 Dec 2010
- Primary completion29 May 2012
- Study completion29 May 2012
Why it stopped: This study was terminated early due to recruitment difficulties. There were no safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370863
- Sponsor's protocol ID
- SPD557-202
- Other IDs
- 2010-021397-12
- Status last verified
- May 2021
- First submitted
- 31 May 2011
- Last updated
- 10 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25530111
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01370863
- Acronym / sponsor ID
- SPD557-202
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, Gastroesophageal reflux disease, SPD557, Proton pump inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated early due to recruitment difficulties. There were no safety concerns.
- Enrolment
- 67 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2010 (actual)
- Primary completion
- 29 May 2012 (actual)
- Study completion
- 29 May 2012 (actual)
- First posted
- 10 Jun 2011 (estimated)
- Results
- Posted 7 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPD557 | Experimental | Drug: SPD557 |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPD5570.5 mg tablet t.i.d. for 4 weeks on top of stable PPI treatment | Drug | SPD557 |
| placebomatching placebo tablet t.i.d. for 4 weeks on top of stable PPI treatment | Drug | Placebo |
Primary outcome
Change From Baseline in the Number of Liquid-containing Reflux Events (pH/MII Monitoring) at 4 Weeks
Time frame: Baseline and 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.
2 secondary outcomes
Change From Baseline in the Number of Days With Heartburn and/or Regurgitation at 4 Weeks
Time frame: Baseline and 4 weeks
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25530111Tack 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPD557 in people with Gastroesophageal Reflux Disease, run by Shire at 15 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Belgium, France, Switzerland, United Kingdom, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01370863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.