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Trial of Ketotifen in Children and Adolescents (Ketotifen)

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ClinicalTrials.gov Identifier: NCT02484248
Recruitment Status : Not yet recruiting
First Posted : June 29, 2015
Last Update Posted : June 29, 2015
Sponsor:
Information provided by (Responsible Party):
Craig A. Friesen, MD, Children's Mercy Hospital Kansas City

Brief Summary:
This study is a double-blind, placebo -controlled, cross-over trial of ketotifen in children ages 8 through 17 inclusive that have a diagnosis of Functional Dyspepsia and have had continued pain despite acid reduction therapy in combination with montelukast. This study is 147 days for subjects responsive to the ketotifen and 63 days for those who are not. The study includes scheduled visits including a physical, blood draws, and questionaires.

Condition or disease Intervention/treatment Phase
Functional Dyspepsia Drug: Ketotifen Drug: Placebo Phase 3

Detailed Description:

The primary aim is to assess the symptomatic response to ketotifen as compared to placebo in children and adolescents with functional dyspepsia in association with duodenal eosinophilia who have previously had worsening, no clinical change, or only a partial response to acid-reduction therapy in combination with montelukast.

Secondary aims include: 1) assessing the impact of ketotifen as compared to placebo on quality of life; 2) assessing the impact of ketotifen as compared to placebo on state and trait anxiety; 3) assessing whether baseline trait anxiety is predictive of clinical response to ketotifen; 4) assessing whether functional dyspepsia subtype is predictive of response to ketotifen, 5) assessing the sustainability of response to ketotifen in initial responders, and 6) assessing the pharmacokinetics of ketotifen in this patient population.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind, Placebo-controlled, Cross-over Trial of Ketotifen in Children and Adolescents With Functional Dyspepsia in Association With Duodenal Eosinophilia
Study Start Date : July 2015
Estimated Primary Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Active Comparator: cross-over of Ketotifen
In this arm patients will begin the active Ketotifen treatment first and cross over to the placebo.
Drug: Ketotifen
Ketotifen is a anti-histamine approved by the U.S. FDA to prevent and treat itching of the eyes caused by allergies.

Placebo Comparator: cross-over of Placebo
In this arm patients will begin the placebo treatment first and cross over to the active Ketotifen.
Drug: Placebo



Primary Outcome Measures :
  1. Complete Physical (the study physician will check all systems and ask questions about pain and symptoms) Change is being assessed. [ Time Frame: day 0, day 28, day 63, and day 147. Change is being assessed from each time period. ]
    Physician directed physical (the study physician will check all systems and ask questions about pain and symptoms). This is a comprehensive system check to ensure safety.

  2. Blood pressure,Change is being assessed. [ Time Frame: day 0, day 28, day 63, and day 147. Change is being assessed from each time period ]
    A Trained professional to complete blood pressure. To ensure value is within normal range and ensure safety of patient.

  3. Liver Functioning Test (a test ran from a blood sample to check a patients liver functioning)Change is being assessed. [ Time Frame: day 0, day 28, day 63, and day 147. Change is being assessed from each time period ]
    Blood Sample collected and tested by a Certified Laboratory. Liver Functioning Test (a test ran from a blood sample to check a patients liver functioning). This will be completed and verified to be within normal ranges by the study physician to ensure patient safety.

  4. State-Trait Inventory for Cognitive and Somatic Anxiety - Child Version, Change is being assessed. [ Time Frame: day 0, day 28, day 63, and day 147. Change is being assessed from each time period ]
    Anxiety Score testing via questionaire. This will be used to look at how anxiety corelates with pain.

  5. Pediatric Quality of Life Inventory, Change is being assessed. [ Time Frame: day 0, day 28, day 63, and day 147. Change is being assessed from each time period ]
    Quality of life survey for pediatrics. This will be completed to ensure maintenance of quality of life throughout study.

  6. Heart Rate, Change is being assessed. [ Time Frame: day 0, day 28, day 63, and day 147. Change is being assessed from each time period ]
    A Trained professional to complete heart rate. To ensure value is within normal range and ensure safety of patient.

  7. Respiratory Rate, Change is being assessed. [ Time Frame: day 0, day 28, day 63, and day 147. Change is being assessed from each time period ]
    A Trained professional to complete respiratory rate. To ensure value is within normal range and ensure safety of patient.


Secondary Outcome Measures :
  1. Pharmacokinetics Sampling(Area under the plasma concentration versus time curve (AUC)) , Change is being assessed. [ Time Frame: day 0, day 28, day 63, and day 147. Change is being assessed from each time period ]
    Pharmacokinetics sampling to be completed for safety. This will be completed to evaluate the entire process of the drug breakdown by the body and ensure long term-effects and safety.

  2. Pharmacokinetics Sampling(Peak Plasma Concentration (Cmax)), Change is being assessed. [ Time Frame: day 0, day 28, day 63, and day 147. Change is being assessed from each time period ]
    Pharmacokinetics sampling to be completed for safety.This will be completed to evaluate the entire process of the drug breakdown by the body and ensure long term-effects and safety.



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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. between the ages of 8 and 17 years, inclusive
  2. abdominal pain of at least 8 weeks duration and fulfilling symptom-based criteria for functional dyspepsia(5);
  3. previous endoscopy with biopsies demonstrating >20 eosinophils/high powered field on duodenal mucosal biopsies;
  4. previous treatment with acid-reduction therapy and montelukast with a level 3 (as defined below)or lesser response;
  5. evidence of written parental permission (consent) and subject assent;
  6. Negative pregnancy screening for females of child bearing potential.

Exclusion Criteria:

  1. previous treatment with ketotifen;
  2. treatment with corticosteroids or oral cromolyn sodium in the four weeks prior to enrollment;
  3. any prior history of diabetes mellitus, cancer, chronic cardiac disease, respiratory disease, or renal disease requiring routine medical care;
  4. Pregnant/planning to become pregnant;
  5. Post-menarche females unwilling to use highly-efficacious contraception to prevent pregnancy;
  6. Epilepsy or history of seizures;
  7. Liver disease or elevation of liver enzymes;
  8. Use of oral hypoglycemic medications, antipsychotics, benzodiazepines, tricyclic antidepressants, barbiturates, or opioids;
  9. Allergy to ketotifen or other products in capsule
  10. Refusal of Urine pregnancy test in post-menarchal females.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484248


Contacts
Contact: Craig A Friesen, M.D. 816-983-6975 cfriesen@cmh.edu
Contact: Trevor J Cole, BS 816-983-6025 tjcole@cmh.edu

Locations
United States, Missouri
The Children's Mercy Hospital Not yet recruiting
Kansas City, Missouri, United States, 64108
Contact: Craig A Friesen, MD    816-983-6985    cfriesen@cmh.edu   
Contact: Trevor J Cole, BS    816-983-6025    tjcole@cmh.edu   
Sponsors and Collaborators
Children's Mercy Hospital Kansas City

Publications:
http://www.drugs.com/mmx/ketotifen-fumarate.html
www.octoberhealth.com/images/Ketotifen_1mg_Product_Information.pdf
Choi MG, Park SJ, Lee SY, Cho YK, Park JM, Han HW, Oh JW, Lee IS, Chung IS. Association of psychological factors with activation of mucosal immune system in functional dyspepsia. Neurogastroenterol Motil 2004; 16:668
Hou XH, Zhu LR, Li QX, Chen JDZ. Alterations in mast cells and 5-HT positive cells in gastric mucosa in functional dyspepsia patients with hypersensitivity. Neurogastroenterol Motil 2001; 13:398-399
La JH, Yang IS. Peripheral CRF mediates visceral hypersensitivity by activating mucosal mast cells in IBS rats. Neurogastroenterol Motil 2005; 17(Suppl 2):39
Friesen CA, Schurman JV, Qadeer A, Andre L, Welchert E, Cocjin J. Relationship between mucosal eosinophils and anxiety in pediatric dyspepsia. Gastroenterology 2005; 129:A-158
Ree MJ, French D, MacLeod C, Locke V. Distinguishing cognitive and somatic dimensions of state and trait anxiety: Development and validation of the State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA). Behavioral and Cognitive Psychotherapy 2008; 36: 313-332
http://www.pedsql.org/about_pedsql.html 82

Responsible Party: Craig A. Friesen, MD, Division Cheif Gastroenterologist, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT02484248     History of Changes
Other Study ID Numbers: 14110467
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: June 29, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Ketotifen
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents