A Phase 1 interventional study of Dexlansoprazole in Heartburn and Gastroesophageal Reflux Disease, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-12-19.
Sponsored by University of North Carolina, Chapel Hill · Phase 1, Interventional, and Basic science
Among 76 studies in Heartburn with a site in United States — 5 open to participants now, 7 under way, 1 of them phase 3. Heartburn · United States.
Among the 76 studies in Heartburn with a site in United States, this one is the 46th largest by enrollment of the 66 interventional ones that give a count, is one of 4 that started in 2010, is one of 7 in phase 1, and was the 39th registered.
154 studies on the registry are indexed under Heartburn; 12 are open to participants now.
Browse Heartburn studies →5 of the 76 studies in Heartburn with a site in United States are open now. Recruiting first, the newest first:
Arizona State University · Sites in United States
Ages 18+
Peach Perfect · Sites in United States
Ages 18–60
Phathom Pharmaceuticals, Inc. · Sites in United States
Ages 15–50 · Women only
Mayo Clinic · Sites in United States
Ages 18+
McMaster University · Sites in United States, Canada
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 8 Heartburn studies recruiting now, 5 set no upper age limit and 3 stop at 75 or younger; 2 take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
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76 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 13 · Phase 3 20 · Phase 4 8
First in 1999; this study’s year is marked. 4 started in 2010.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 40 is below the median of 100 across 127 interventional studies indexed under Heartburn.
Median enrollment 98 across the 66 interventional studies, 414 across the 10 observational. Of the 63 that completed or were terminated, 28 (44%) have results posted.
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45 of 76 have an industry lead sponsor. The 10 most frequent:
University of North Carolina, Chapel Hill is the lead sponsor of 1,373 studies on the registry; 134 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
University of North Carolina, Chapel Hill has 3 studies filed under Heartburn — fewer than ten, so there is no comparison to draw.
3 of the studies in Heartburn with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01696734Phase 3M.D. Anderson Cancer CenterDomperidone in Treating Patients With Gastrointestinal Disorders | 2027-10-31 |
| NCT05976165Mayo ClinicA Study of Breath Testing for Small Intestinal Bacterial Overgrowth | 2027-01-01 |
| NCT07927296Arizona State UniversityVinegar and Heartburn | 2027-05-15 |
Add all 3 to your calendar (.ics) → With an account.
Among the 76 studies in Heartburn with a site in United States, from their registry updates:
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The purpose of this research study is to determine in heartburn patients with nonerosive disease if detecting the presence of a fragment of the protein e-cadherin in esophageal epithelium or the amount of fragments of e-cadherin in blood can be used to monitor healing of esophagitis treated with a proton pump inhibitor (PPI). The hypothesis is that the presence of fragments of e-cadherin in esophageal epithelium or the amount of fragments of e-cadherin in blood can you useful as a biomarker for the healing of esophagitis in patients successfully treated with a PPI.
The symptom of heartburn was once a reliable indicator of gastroesophageal reflux disease (GERD) and as such patients would predictably respond to acid inhibition. In the post-proton pump inhibitor (PPI) world, neither of these statements is true since many patients presenting with heartburn have symptoms mediated by mechanisms unrelated to esophageal luminal acidity, e.g. functional disease, visceral hypersensitivity or activation of esophageal stretch receptors. Consequently these subjects fail to respond to PPIs[1-3]. Since PPI-responsive and PPI-refractory patients with heartburn are indistinguishable by history, it is difficult to determine which PPI-unresponsive subjects may respond to higher doses of a PPI. Additionally, when subjects do respond to PPI therapy, symptom response may not correlate with lesion healing, making a systemic marker of healing highly desirable. Lesion healing is particularly problematic since the histopathologic lesion that correlates best with heartburn is the presence of dilated intercellular spaces (DIS) within esophageal epithelium, which cannot be detected by with standard endoscopy, and is most reliably demonstrable by performing transmission electron microscopy[4-7]. Consequently, it would be desirable to have an objective marker of acid-mediated injury to esophageal epithelium that could identify those with PPI-responsive heartburn and determine healing of acid-damaged epithelium non-invasively.
DIS in esophageal epithelium has been established as an early histopathologic feature of gastroesophageal reflux disease (GERD). This electron microscopic lesion is present in both erosive and nonerosive forms of GERD and results from acid damage to the intercellular junctional complex that controls paracellular permeability within esophageal epithelium[8]. Further, it is known that treatment with PPIs results in resolution of DIS along with that of heartburn in patients with both erosive and nonerosive types of GERD[9]. E-cadherin is a protein which forms the intercellular adhesive bridge of the zonula adherens (ZA)[10]; and the ZA plays an integral role in maintaining the integrity of the tight junction between cells such that loss of adhesion between bridging molecules of e-cadherin results in loss of barrier function and increased paracellular permeability[11,12]. Therefore, under conditions where an acidic refluxate is present within the esophageal lumen, a 'leaky' junctional barrier promotes excessive entry of hydrogen ions into and so acidification of the intercellular space, which in turn triggers heartburn by activation of acid-sensitive neurons within the mucosa[13].
Recently, my lab has found that DIS in non-erosive acid-damage to (rabbit) esophageal epithelium is associated on Western blots with cleavage of the intercellular portion of e-cadherin and that this cleavage occurs by acid activation of an endogenous proteolytic process (unpublished observations). Moreover, this same phenomenon on Western blots is replicated in human esophagus of patients with GERD, i.e. endoscopic biopsies of esophageal epithelium reveal cleavage of e-cadherin in those with both erosive and non-erosive forms of GERD but is not present within the esophageal epithelium of healthy subjects or subjects without signs or symptoms of esophageal disease[14] - see Fig 4 of attached poster presentation. Specifically, cleavage of e-cadherin in GERD patients leaves behind within the esophageal epithelium a cytoplasmic 'C-terminal fragment (CTF)' of the molecule and this CTF is readily detected on Western blot. Interestingly, the size of the CTF is consistent, as in the rabbit model, with cleavage of e-cadherin by an endogenous matrix metalloprotease. Also noteworthy is that the other cleaved extracellular component of e-cadherin is an 'N-terminal fragment (NTF)' and this fragment is absorbed into the blood stream resulting in higher serum levels of NTFs of e-cadherin than healthy subjects as detectable using a commercial ELISA assay[14] - see Fig. 6 of attached poster presentation. Since CTFs on Western blot of endoscopic biopsies and elevated NTFs of e-cadherin by ELISA in serum are a reflection of acid-injured esophageal epithelium, this suggests the tantalizing possibility of a sensitive, minimally invasive (serum) test for esophageal mucosal damage in the GERD subject. We hypothesize that determination of either of the cleaved fragments of e-cadherin (serum or tissue-based) can discriminate between patients with acid-mediated heartburn who are likely to be PPI-responsive and those whose heartburn symptoms are not mediated by acid and so are PPI-refractory.
The hypothesis will be tested by determining the presence or absence of CTFs of e-cadherin on esophageal biopsy and by measuring the level of NTFs of e-cadherin in serum of endoscopy-negative patients with heartburn and correlating the findings with the patient's (heartburn) response to Kapidex 30 mg for 4 weeks. Based on effective heartburn control on Kapidex or lack thereof, patients will be classified as having PPI-responsive or PPI-refractory disease, respectively, and these classifications correlated with presence or absence of CTFs on pretreatment biopsy and pretreatment serum level of NTFs of e-cadherin. Also, after 4 weeks of Kapidex, repeat serum specimens for NTFs are obtained from all treated patients to determine, as a marker of healing, whether the serum level of NTFs post-treatment are significantly lower than pretreatment serum level of NTFs in those that have PPI-responsive heartburn but not in those that have PPI-refractory heartburn.
The results of this study are expected to show that patients with PPI-responsive heartburn have CTFs of e-cadherin in tissue and higher levels of NTFs of e-cadherin in serum at baseline, and that these levels decrease after successful PPI therapy. In contrast, because symptoms in PPI-refractory subjects are not acid-mediated, these subjects are expected to lack CTFs in tissue and to have lower levels of NTFs in serum at baseline compared to PPI-responsive patients, and these levels will remain unchanged after PPI therapy. Consequently, such findings would establish detection of cleaved fragments of e-cadherin in tissue and blood as useful biomarkers of disease that can identify those with heartburn that are responsive to standard doses of Kapidex. The results are also expected to show that patients with PPI-responsive heartburn, but not those with PPI-refractory heartburn, have a significant decline in the level of NTFs in serum post-treatment and that this lower level of NTFs is expected to fall within the range of controls. Consequently, such findings would establish that detection of serum NTFs before and after treatment can be useful as a biomarker of (microscopic) lesion healing in those with PPI-responsive heartburn. Such findings might help select sub-groups appropriate for more intensive (higher dose) or long term PPI therapy.
Inclusion Criteria: (all responses must be Yes)
Exclusion Criteria:(all responses must be No)
History of:
Had the following surgeries:
Have any of the following:
Currently taking any of the following medications:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Dexlansoprazole
Dosage: 30 mg once per day for 4 weeks by mouth
Also known as: Kapidex
Dexlansoprazole
Primary outcome measure: To determine whether detection of cleaved fragments of e-cadherin in esophageal biopsies and in serum can discriminate between nonerosive patients with PPI-responsive and PPI-refractory heartburn.
Time frame: 4 weeks
Dexlansoprazole
To determine whether serum levels of N-terminal fragments of e-cadherin can be useful to monitor esophageal healing in patients with nonerosive PPI-responsive heartburn.
Time frame: 4 weeks
The record gives a start of Jun 2010, a primary completion of Apr 2012 and a completion of Apr 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexlansoprazole
University of North Carolina, Chapel Hill →