This trial is testing whether ketotifen, a mast cell stabilizer, is effective in treating functional dyspepsia (FD), a common childhood stomach disorder. Acid reduction is the most common FD treatment, but when it fails, ketotifen may be an effective alternative.
7 Primary · 2 Secondary · Reporting Duration: day 0, day 28, day 63, and day 147
2 Treatment Groups
cross-over of Ketotifen
1 of 2
cross-over of Placebo
1 of 2
40 Total Participants · 2 Treatment Groups
Primary Treatment: cross-over of Ketotifen · Has Placebo Group · Phase 3
Who is running the clinical trial?
Age 8 - 17 · All Participants · 6 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- McFadyen, M. L., R. Miller, and T. M. Ludden. 1997. “Ketotifen Pharmacokinetics in Children with Atopic Perennial Asthma”. European Journal of Clinical Pharmacology. Springer Science and Business Media LLC. doi:10.1007/s002280050305.
- Klooker, T. K., B. Braak, K. E. Koopman, O. Welting, M. M. Wouters, S. van der Heide, M. Schemann, S. C. Bischoff, R. M. van den Wijngaard, and G. E. Boeckxstaens. 2010. “The Mast Cell Stabiliser Ketotifen Decreases Visceral Hypersensitivity and Improves Intestinal Symptoms in Patients with Irritable Bowel Syndrome”. Gut. BMJ. doi:10.1136/gut.2010.213108.
- Schurman, Jennifer V, Meenal Singh, Vivekanand Singh, Nancy Neilan, and Craig A Friesen. 2010. “Symptoms and Subtypes in Pediatric Functional Dyspepsia: Relation to Mucosal Inflammation and Psychological Functioning”. Journal of Pediatric Gastroenterology & Nutrition. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mpg.0b013e3181d1363c.
- Hall, Wendy, Martin Buckley, Paul Crotty, and Colm A O’Morain. 2003. “Gastric Mucosal Mast Cells Are Increased in Helicobacter Pylori-negative Functional Dyspepsia”. Clinical Gastroenterology and Hepatology. Elsevier BV. doi:10.1053/s1542-3565(03)00184-8.
- Friesen, Craig A., Zhiyue Lin, Meenal Singh, Vivekanand Singh, Jennifer V. Schurman, Nanci Burchell, Jose T. Cocjin, and Richard W. McCallum. 2008. “Antral Inflammatory Cells, Gastric Emptying, and Electrogastrography in Pediatric Functional Dyspepsia”. Digestive Diseases and Sciences. Springer Science and Business Media LLC. doi:10.1007/s10620-008-0207-0.
- Friesen, Craig A, Nancy A Neilan, Jennifer V Schurman, Debra L Taylor, Gregory L Kearns, and Susan M Abdel-Rahman. 2009. “Montelukast in the Treatment of Duodenal Eosinophilia in Children with Dyspepsia: Effect on Eosinophil Density and Activation in Relation to Pharmacokinetics”. BMC Gastroenterology. Springer Science and Business Media LLC. doi:10.1186/1471-230x-9-32.
- Santos, Javier, Esteban Saperas, Carmen Nogueiras, Marisabel Mourelle, María Antolín, Alvaro Cadahia, and Juan–R. Malagelada. 1998. “Release of Mast Cell Mediators into the Jejunum by Cold Pain Stress in Humans”. Gastroenterology. Elsevier BV. doi:10.1016/s0016-5085(98)70577-3.
- Chen, Xiaoyan, Dafang Zhong, Dan Liu, Yingwu Wang, Ying Han, and Jingkai Gu. 2003. “Determination of Ketotifen and Its Conjugated Metabolite in Human Plasma by Liquid Chromatography/tandem Mass Spectrometry: Application to a Pharmacokinetic Study”. Rapid Communications in Mass Spectrometry. Wiley. doi:10.1002/rcm.1189.
- Stefanini, G. F., A. Saggioro, V. Alvisi, G. Angelini, L. Capurso, G. Di Lorenzo, G. Dobrilla, et al.. 1995. “Oral Cromolyn Sodium in Comparison with Elimination Diet in the Irritable Bowel Syndrome, Diarrheic Type Multicenter Study of 428 Patients”. Scandinavian Journal of Gastroenterology. Informa UK Limited. doi:10.3109/00365529509089786.
- Grahnén, A., A. Lönnebo, O. Beck, S-Å Eckernäs, B. Dahlström, and B. Lindström. 1992. “Pharmacokinetics of Ketotiffn After Oral Administration to Healthy Male Subjects”. Biopharmaceutics & Drug Disposition. Wiley. doi:10.1002/bdd.2510130404.
- Grahnen A, Lonnebo A, Beck O, Eckernas SA, Dahlstrom B, Lindstrom B. Pharmacokinetics of ketotifen after oral administration to healthy male subjects. Biopharm Drug Dispos. 1992 May;13(4):255-62. doi: 10.1002/bdd.2510130404.
- McFadyen ML, Miller R, Ludden TM. Ketotifen pharmacokinetics in children with atopic perennial asthma. Eur J Clin Pharmacol. 1997;52(5):383-6. doi: 10.1007/s002280050305.
- Chen X, Zhong D, Liu D, Wang Y, Han Y, Gu J. Determination of ketotifen and its conjugated metabolite in human plasma by liquid chromatography/tandem mass spectrometry: application to a pharmacokinetic study. Rapid Commun Mass Spectrom. 2003;17(22):2459-63. doi: 10.1002/rcm.1189.
- Stefanini GF, Saggioro A, Alvisi V, Angelini G, Capurso L, di Lorenzo G, Dobrilla G, Dodero M, Galimberti M, Gasbarrini G, et al. Oral cromolyn sodium in comparison with elimination diet in the irritable bowel syndrome, diarrheic type. Multicenter study of 428 patients. Scand J Gastroenterol. 1995 Jun;30(6):535-41. doi: 10.3109/00365529509089786.
- Hall W, Buckley M, Crotty P, O'Morain CA. Gastric mucosal mast cells are increased in Helicobacter pylori-negative functional dyspepsia. Clin Gastroenterol Hepatol. 2003 Sep;1(5):363-9. doi: 10.1053/s1542-3565(03)00184-8.
- Santos J, Saperas E, Nogueiras C, Mourelle M, Antolin M, Cadahia A, Malagelada JR. Release of mast cell mediators into the jejunum by cold pain stress in humans. Gastroenterology. 1998 Apr;114(4):640-8. doi: 10.1016/s0016-5085(98)70577-3.
- Craig A. Friesen, MD 2015. "Ketotifen for Children With Functional Dyspepsia in Association With Duodenal Eosinophilia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02484248.
Frequently Asked Questions
What are Ketotifen's most common indications?
"Ketotifen can be used to provide relief for seasonal allergic conjunctivitis, allergic conjunctivitis (ac), and other eye allergies." - Anonymous Online Contributor
Can elderly patients over the age of seventy-five participate in this research?
"In order to take part in this research, volunteers must be aged between 8 and 17. There are 11 other similar trials for minors and 33 for elderly patients." - Anonymous Online Contributor
How many total individuals are included in this research project?
"Yes, the information on clinicaltrials.gov suggests that this trial is presently recruiting candidates. The clinical trial was first posted on 8/1/2015 and was last edited on 10/10/2022. The trial is looking for 40 participants across 1 locations." - Anonymous Online Contributor
Are there any other investigations that have looked into Ketotifen's ability to be effective across different treatments?
"Currently, there are 3 clinical trials testing Ketotifen's efficacy through a cross-over design. Of those, 3 are in Phase 3. Most trials are being conducted in Burlington, Vermont, but 20 other locations across the United States are also running similar trials." - Anonymous Online Contributor
Is Ketotifen cross-over dangerous for people?
"There is some efficacy data and multiple rounds of safety data supporting the use of Ketotifen in this Phase 3 trial, so our team at Power has rated the safety of this drug as a 3." - Anonymous Online Contributor
Are new patients currently being accepted into this clinical trial?
"Yes, correct. The clinical trial is still looking for participants and was last updated on October 10th, 2022. The study was first posted on August 1st, 2015 and is looking for a total of 40 individuals from 1 site." - Anonymous Online Contributor
May I join this investigation if I meet the requirements?
"This study is searching for young patients, aged 8-17, that have eosinophilia and abdominal pain lasting for at least 8 weeks. The ideal candidate also must have had a previous endoscopy with biopsies that showed eosinophils in the duodenum, as well as treatment with acid-reduction therapy and montelukast that didn't produce the desired results." - Anonymous Online Contributor