Epigastric PainTRPV1NCT00677378
Transient Receptor Potential Vanilloid One (TRPV1) Receptor Expression in Children With Retrosternal Pain
An observational study of Epigastric Pain and Retrosternal Pain, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
We would like to evaluate the changes in nerve innervation and TRPV1 receptor expression along with microscopic changes associated with heart burn and abdominal pain Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Epigastric Pain, Retrosternal Pain, Esophagitis
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Oct 2015
- Phase
- Observational
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children undergoing an endoscopy procedure for gastrointestinal symptoms and chest pain or reasons other than those listed in the exclusion criteria.
Who may be able to join
- Retrosternal and/or epigastric pain and esophagitis
- Retrosternal and/or epigastric pain but no macroscopic or microscopic esophagitis
- Gastrointestinal symptoms such as diarrhea, regurgitation, rumination, vomiting, feeding aversion, non-organic failure to thrive, celiac disease with no macroscopic or microscopic esophageal inflammation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Capsaicin-sensitive Transient Receptor Potential Vanilloid One (TRPV1) and Tyrosine Kinase (TrkA) Receptor Expression in Children With Retrosternal Pain
We would like to evaluate the changes in nerve innervation and TRPV1 receptor expression along with microscopic changes associated with heart burn and abdominal pain
Read the detailed description
Approximately 5% of children between 10-17 years of age report symptoms of heart burn, epigastric pain or regurgitation. This study will evaluate the changes in nerve innervation and TRPV1 receptor expression in children having upper endoscopy for evaluation of heart burn and abdominal pain.
- Keywords
- TRPV1, Nerve growth factor, Capsaicin, TrkA, Retrosternal pain, Epigastric pain, Esophagitis, Gastrointestinal symptoms
- Medical subject headings
- Esophagitis, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL | Children undergoing an endoscopy for retrosternal chest pain, epigastric pain, regurgitation, heart burn or dyspepsia. | |
| CONTROL | Children undergoing an endoscopy for reasons not stated in the experimental group condition (i.e. celiac disease, rectal bleeding, polyps, weight loss, malabsorption). |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the TRPV1 expression in the esophageal mucosa of children with esophagitis and to correlate the TRPV1 expression with severity of mucosal inflammation and microscopic changes.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study startDec 2006
- Primary completionDec 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Epigastric PainStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manu Sood, Medical College of Wisconsin
- Investigators
- Manu Sood, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677378
- Sponsor's protocol ID
- CHW 06/34
- Acronym
- TRPV1
- Status last verified
- Oct 2015
- First submitted
- 9 May 2008
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nelson SP, Chen EH, Syniar GM, Christoffel KK. Prevalence of symptoms of gastroesophageal reflux during childhood: a pediatric practice-based survey. Pediatric Practice Research Group. Arch Pediatr Adolesc Med. 2000 Feb;154(2):150-4. doi: 10.1001/archpedi.154.2.150.
PubMed 10665601El-Serag HB, Bailey NR, Gilger M, Rabeneck L. Endoscopic manifestations of gastroesophageal reflux disease in patients between 18 months and 25 years without neurological deficits. Am J Gastroenterol. 2002 Jul;97(7):1635-9. doi: 10.1111/j.1572-0241.2002.05820.x.
PubMed 12135011Carlsson R, Galmiche JP, Dent J, Lundell L, Frison L. Prognostic factors influencing relapse of oesophagitis during maintenance therapy with antisecretory drugs: a meta-analysis of long-term omeprazole trials. Aliment Pharmacol Ther. 1997 Jun;11(3):473-82. doi: 10.1046/j.1365-2036.1997.00167.x.
PubMed 9218069Sarkar S, Hobson AR, Furlong PL, Woolf CJ, Thompson DG, Aziz Q. Central neural mechanisms mediating human visceral hypersensitivity. Am J Physiol Gastrointest Liver Physiol. 2001 Nov;281(5):G1196-202. doi: 10.1152/ajpgi.2001.281.5.G1196.
PubMed 11668028Mehta AJ, De Caestecker JS, Camm AJ, Northfield TC. Sensitization to painful distention and abnormal sensory perception in the esophagus. Gastroenterology. 1995 Feb;108(2):311-9. doi: 10.1016/0016-5085(95)90055-1.
PubMed 7835571Cervero F. Visceral hyperalgesia revisited. Lancet. 2000 Sep 30;356(9236):1127-8. doi: 10.1016/S0140-6736(00)02750-1. No abstract available.
PubMed 11030288Faussone-Pellegrini MS, Taddei A, Bizzoco E, Lazzeri M, Vannucchi MG, Bechi P. Distribution of the vanilloid (capsaicin) receptor type 1 in the human stomach. Histochem Cell Biol. 2005 Jul;124(1):61-8. doi: 10.1007/s00418-005-0025-9. Epub 2005 Jul 22.
PubMed 16041554Cervero F, Laird JM. Understanding the signaling and transmission of visceral nociceptive events. J Neurobiol. 2004 Oct;61(1):45-54. doi: 10.1002/neu.20084.
PubMed 15362152Yiangou Y, Facer P, Dyer NH, Chan CL, Knowles C, Williams NS, Anand P. Vanilloid receptor 1 immunoreactivity in inflamed human bowel. Lancet. 2001 Apr 28;357(9265):1338-9. doi: 10.1016/s0140-6736(00)04503-7.
PubMed 11343743Chan CL, Facer P, Davis JB, Smith GD, Egerton J, Bountra C, Williams NS, Anand P. Sensory fibres expressing capsaicin receptor TRPV1 in patients with rectal hypersensitivity and faecal urgency. Lancet. 2003 Feb 1;361(9355):385-91. doi: 10.1016/s0140-6736(03)12392-6.
PubMed 12573376Lewin GR, Mendell LM. Nerve growth factor and nociception. Trends Neurosci. 1993 Sep;16(9):353-9. doi: 10.1016/0166-2236(93)90092-z.
PubMed 7694405Anand P, Terenghi G, Warner G, Kopelman P, Williams-Chestnut RE, Sinicropi DV. The role of endogenous nerve growth factor in human diabetic neuropathy. Nat Med. 1996 Jun;2(6):703-7. doi: 10.1038/nm0696-703.
PubMed 8640566Micera A, Puxeddu I, Aloe L, Levi-Schaffer F. New insights on the involvement of Nerve Growth Factor in allergic inflammation and fibrosis. Cytokine Growth Factor Rev. 2003 Oct;14(5):369-74. doi: 10.1016/s1359-6101(03)00047-9.
PubMed 12948520Anand P, Pandya S, Ladiwala U, Singhal B, Sinicropi DV, Williams-Chestnut RE. Depletion of nerve growth factor in leprosy. Lancet. 1994 Jul 9;344(8915):129-30. doi: 10.1016/s0140-6736(94)91316-1. No abstract available.
PubMed 7912365Indo Y. Genetics of congenital insensitivity to pain with anhidrosis (CIPA) or hereditary sensory and autonomic neuropathy type IV. Clinical, biological and molecular aspects of mutations in TRKA(NTRK1) gene encoding the receptor tyrosine kinase for nerve growth factor. Clin Auton Res. 2002 May;12 Suppl 1:I20-32. doi: 10.1007/s102860200016.
PubMed 12102460
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capsaicin-sensitive Transient Receptor Potential Vanilloid One (TRPV1) and Tyrosine Kinase (TrkA) Receptor Expression in Children With Retrosternal Pain
- ClinicalTrials.gov ID
- NCT00677378
- Acronym / sponsor ID
- TRPV1 / CHW 06/34
- Keywords
- TRPV1, Nerve growth factor, Capsaicin, TrkA, Retrosternal pain, Epigastric pain, Esophagitis, Gastrointestinal symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 14 May 2008 (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.
We would like to evaluate the changes in nerve innervation and TRPV1 receptor expression along with microscopic changes associated with heart burn and abdominal pain
Detailed description
Approximately 5% of children between 10-17 years of age report symptoms of heart burn, epigastric pain or regurgitation. This study will evaluate the changes in nerve innervation and TRPV1 receptor expression in children having upper endoscopy for evaluation of heart burn and abdominal pain.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL | – | –Children undergoing an endoscopy for retrosternal chest pain, epigastric pain, regurgitation, heart burn or dyspepsia. |
| CONTROL | – | –Children undergoing an endoscopy for reasons not stated in the experimental group condition (i.e. celiac disease, rectal bleeding, polyps, weight loss, malabsorption). |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children undergoing an endoscopy procedure for gastrointestinal symptoms and chest pain or reasons other than those listed in the exclusion criteria.
Key inclusion criteria (3 listed)
- Retrosternal and/or epigastric pain and esophagitis
- Retrosternal and/or epigastric pain but no macroscopic or microscopic esophagitis
- Gastrointestinal symptoms such as diarrhea, regurgitation, rumination, vomiting, feeding aversion, non-organic failure to thrive, celiac disease with no macroscopic or microscopic esophageal inflammation
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To characterize the TRPV1 expression in the esophageal mucosa of children with esophagitis and to correlate the TRPV1 expression with severity of mucosal inflammation and microscopic changes.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
- Background: PubMed 10665601Nelson SP, Chen EH, Syniar GM, Christoffel KK. Prevalence of symptoms of gastroesophageal reflux during childhood: a pediatric practice-based survey. Pediatric Practice Research Group. Arch Pediatr Adolesc Med. 2000 Feb;154(2):150-4. doi: 10.1001/archpedi.154.2.150.
- Background: PubMed 12135011El-Serag HB, Bailey NR, Gilger M, Rabeneck L. Endoscopic manifestations of gastroesophageal reflux disease in patients between 18 months and 25 years without neurological deficits. Am J Gastroenterol. 2002 Jul;97(7):1635-9. doi: 10.1111/j.1572-0241.2002.05820.x.
- Background: PubMed 9218069Carlsson R, Galmiche JP, Dent J, Lundell L, Frison L. Prognostic factors influencing relapse of oesophagitis during maintenance therapy with antisecretory drugs: a meta-analysis of long-term omeprazole trials. Aliment Pharmacol Ther. 1997 Jun;11(3):473-82. doi: 10.1046/j.1365-2036.1997.00167.x.
- Background: PubMed 11668028Sarkar S, Hobson AR, Furlong PL, Woolf CJ, Thompson DG, Aziz Q. Central neural mechanisms mediating human visceral hypersensitivity. Am J Physiol Gastrointest Liver Physiol. 2001 Nov;281(5):G1196-202. doi: 10.1152/ajpgi.2001.281.5.G1196.
- Background: PubMed 7835571Mehta AJ, De Caestecker JS, Camm AJ, Northfield TC. Sensitization to painful distention and abnormal sensory perception in the esophagus. Gastroenterology. 1995 Feb;108(2):311-9. doi: 10.1016/0016-5085(95)90055-1.
- Background: PubMed 11030288Cervero F. Visceral hyperalgesia revisited. Lancet. 2000 Sep 30;356(9236):1127-8. doi: 10.1016/S0140-6736(00)02750-1. No abstract available.
- Background: PubMed 16041554Faussone-Pellegrini MS, Taddei A, Bizzoco E, Lazzeri M, Vannucchi MG, Bechi P. Distribution of the vanilloid (capsaicin) receptor type 1 in the human stomach. Histochem Cell Biol. 2005 Jul;124(1):61-8. doi: 10.1007/s00418-005-0025-9. Epub 2005 Jul 22.
- Background: PubMed 15362152Cervero F, Laird JM. Understanding the signaling and transmission of visceral nociceptive events. J Neurobiol. 2004 Oct;61(1):45-54. doi: 10.1002/neu.20084.
- Background: PubMed 11343743Yiangou Y, Facer P, Dyer NH, Chan CL, Knowles C, Williams NS, Anand P. Vanilloid receptor 1 immunoreactivity in inflamed human bowel. Lancet. 2001 Apr 28;357(9265):1338-9. doi: 10.1016/s0140-6736(00)04503-7.
- Background: PubMed 12573376Chan CL, Facer P, Davis JB, Smith GD, Egerton J, Bountra C, Williams NS, Anand P. Sensory fibres expressing capsaicin receptor TRPV1 in patients with rectal hypersensitivity and faecal urgency. Lancet. 2003 Feb 1;361(9355):385-91. doi: 10.1016/s0140-6736(03)12392-6.
- Background: PubMed 7694405Lewin GR, Mendell LM. Nerve growth factor and nociception. Trends Neurosci. 1993 Sep;16(9):353-9. doi: 10.1016/0166-2236(93)90092-z.
- Background: PubMed 8640566Anand P, Terenghi G, Warner G, Kopelman P, Williams-Chestnut RE, Sinicropi DV. The role of endogenous nerve growth factor in human diabetic neuropathy. Nat Med. 1996 Jun;2(6):703-7. doi: 10.1038/nm0696-703.
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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.
Manu Sood, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epigastric Pain and Retrosternal Pain, run by Medical College of Wisconsin 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 3 inclusion and 0 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: finished, as of the sponsor's last update on 22 Oct 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To characterize the TRPV1 expression in the esophageal mucosa of children with esophagitis and to correlate the TRPV1 expression with severity of mucosal inflammation and microscopic changes. (time frame: 5 years). 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 NCT00677378, which also lists 16 linked publications.
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 22 Oct 2015.