Chest PainPhase 4DexilantNCT01637571
Dexilant Treatment in Gastrointestinal Reflux Disease (GERD Related Non Cardiac Chest Pain
A Phase 4 study testing Dexilant in people with Chest Pain and Gastrointestinal Reflux Disease, run by University of Iowa at 1 site in United States.
Trial summary
The purpose of this study is to investigate a new treatment for non-cardiac chest pain (NCCP) related to gastrointestinal reflux disease (GERD), called Dexilant. The investigators would like to test its effectiveness in treating NCCP. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chest Pain, Gastrointestinal Reflux Disease
- What is being tested?
- Dexilant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years
- NERD, or GERD LA Class A-B (endoscopy)
- Subjects with positive pH testing
- At least one episode of chest pain a week in the past month
- Previous negative cardiac evaluation (EKG ± stress test ± coronary angiogram)
- Negative esophageal evaluation for a motility disorder (Nutcracker esophagus, achalasia)
Who cannot join
- Subjects requiring narcotics or other pain medications, Subjects with known LA class C-D, Barrett's esophagus or peptic stricture on endoscopy
- Subjects with previous upper gastrointestinal surgery
- Pregnancy
- Subjects with diabetes, neuromuscular disorders, or other severe co-morbidities
- (Cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic, and psychiatric).
- Subjects with upper airway symptoms (such as hoarseness, wheezing, laryngospasm).
- Medications such as baclofen, and prokinetic agents.
- History of substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: The Effect of Dexilant Treatment on Esophageal Hypersensitivity in GERD Related Non Cardiac Chest Pain Patients
The purpose of this study is to investigate a new treatment for non-cardiac chest pain (NCCP) related to gastrointestinal reflux disease (GERD), called Dexilant. The investigators would like to test its effectiveness in treating NCCP.
The patient will undergo esophageal balloon distention testing (EBDT) before and after taking the new treatment for one month (Dexilant). EBDT evaluates the sensation and mechanical properties of the esophagus. A catheter with a deflated balloon is placed through the mouth and into the esophagus and the balloon is inflated with water. ECG and labs will be done throughout the study as a measurement of safety.
- Conditions
- Chest Pain, Gastrointestinal Reflux Disease
- Being tested
- Dexilant, Dexilant Placebo
- Keywords
- GERD, NCCP, chest pain, reflux, GERD related non-cardiac chest pain
- Medical subject headings
- Chest Pain, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexilantDrug
60mg of Dexilant QD for 12 weeks
Dexilant PlaceboDrug
Also called Dexlansoprazole
60mg of Dexilant placebo QD for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dexilant | Active comparator | 60mg of Dexilant QD for 12 weeks Receives: Drug: Dexilant |
| Placebo | Placebo comparator | 60mg of Dexilant placebo QD for 12 weeks Receives: Drug: Dexilant Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of chest pain episodes in treatment vs placebo groups
the number of chest pain episodes during the study
Measured: 12 weeks
Secondary outcomes (5)
Intensity of chest pain episodes
how strong the chest pain episodes are
Measured: 12 weeks
Sensory thresholds for first sensation
the balloon distension level when a sensation is first felt
Measured: 12 weeks
Sensory thresholds for discomfort
the balloon distension level when discomfort is felt
Measured: 12 weeks
Sensory thresholds for pain
the balloon distension level when pain is felt
Measured: 12 weeks
duration of chest pain episodes
how long the chest pain episodes last
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
Why it stopped: Sponsor could not fund
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ron Schey, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637571
- Sponsor's protocol ID
- 201102718
- Acronym
- Dexilant
- Status last verified
- Jul 2012
- First submitted
- 6 Dec 2011
- Last updated
- 11 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexilant Treatment on Esophageal Hypersensitivity in GERD Related Non Cardiac Chest Pain Patients
- ClinicalTrials.gov ID
- NCT01637571
- Acronym / sponsor ID
- Dexilant / 201102718
- Conditions
- Chest Pain, Gastrointestinal Reflux Disease
- Keywords
- GERD, NCCP, chest pain, reflux, GERD related non-cardiac chest pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor could not fund
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- First posted
- 11 Jul 2012 (estimated)
- Results
- Not posted in the source record
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 study is to investigate a new treatment for non-cardiac chest pain (NCCP) related to gastrointestinal reflux disease (GERD), called Dexilant. The investigators would like to test its effectiveness in treating NCCP.
The patient will undergo esophageal balloon distention testing (EBDT) before and after taking the new treatment for one month (Dexilant). EBDT evaluates the sensation and mechanical properties of the esophagus. A catheter with a deflated balloon is placed through the mouth and into the esophagus and the balloon is inflated with water. ECG and labs will be done throughout the study as a measurement of safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexilant | Active comparator | Drug: Dexilant60mg of Dexilant QD for 12 weeks |
| Placebo | Placebo comparator | Drug: Dexilant Placebo60mg of Dexilant placebo QD for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-75 years
- NERD, or GERD LA Class A-B (endoscopy)
- Subjects with positive pH testing
- At least one episode of chest pain a week in the past month
- Previous negative cardiac evaluation (EKG ± stress test ± coronary angiogram)
Key exclusion criteria (8 listed)
- Subjects requiring narcotics or other pain medications, Subjects with known LA class C-D, Barrett's esophagus or peptic stricture on endoscopy
- Subjects with previous upper gastrointestinal surgery
- Pregnancy
- Subjects with diabetes, neuromuscular disorders, or other severe co-morbidities
- (Cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic, and psychiatric).
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 |
|---|---|---|
| Dexilant60mg of Dexilant QD for 12 weeks | Drug | Dexilant |
| Dexilant PlaceboAlso: Dexlansoprazole60mg of Dexilant placebo QD for 12 weeks | Drug | Placebo |
Primary outcome
Frequency of chest pain episodes in treatment vs placebo groups
Time frame: 12 weeks
the number of chest pain episodes during the study
5 secondary outcomes
Intensity of chest pain episodes
Time frame: 12 weeks
Sensory thresholds for first sensation
Time frame: 12 weeks
Sensory thresholds for discomfort
Time frame: 12 weeks
Sensory thresholds for pain
Time frame: 12 weeks
duration of chest pain episodes
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2012.
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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.
Ron Schey, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexilant in people with Chest Pain and Gastrointestinal Reflux Disease, run by University of Iowa at 1 site in United States.
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 6 inclusion and 8 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: withdrawn, as of the sponsor's last update on 11 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Frequency of chest pain episodes in treatment vs placebo groups (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2012.