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A Study to Evaluate the Safety and Efficacy of Domperidone in Pediatric Participants With Nausea and Vomiting Due to Acute Gastroenteritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02699385
Recruitment Status : Terminated (Study prematurely terminated upon recommendation of IDMC due to lack of efficacy.)
First Posted : March 4, 2016
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV

Brief Summary:
The purpose of this study is to demonstrate that domperidone suspension plus oral rehydration therapy (ORT) is more effective than placebo plus ORT at reducing the symptoms of vomiting associated with acute gastroenteritis (AG) within the first 48 hours of treatment administration in pediatric participants with AG and mild-to-moderate dehydration.

Condition or disease Intervention/treatment Phase
Gastroenteritis Other: Oral Rehydration Therapy Drug: Domperidone Drug: Placebo Phase 3

Detailed Description:
This is a randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), parallel-group, placebo-controlled, multicenter (when more than one hospital or medical school team work on a medical research study) study. The study consists of 3 Phases: Screening Phase (-2 to 0 hours prior to baseline on Day 1), Double-blind treatment Phase (up to 7 Days) and follow-up Phase (7 Days). The duration of participation in the study for each participant is at most 15 Days. Efficacy and safety of domperidone will be evaluated. Participants' safety will be monitored throughout the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, Prospective Study to Evaluate the Safety and Efficacy of Domperidone in 6-month-old to 12-year-old Pediatric Subjects With Nausea and Vomiting Due to Acute Gastroenteritis
Actual Study Start Date : December 7, 2015
Actual Primary Completion Date : August 3, 2017
Actual Study Completion Date : August 3, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Domperidone

Arm Intervention/treatment
Experimental: Oral Rehydration Therapy (ORT) + Domperidone
Each participants will initiate ORT in the physician's office and domperidone 0.25 milligram per kilogram (mg/kg) of body weight of oral suspension thrice daily for up to 7 days.
Other: Oral Rehydration Therapy
Each participants will initiate ORT in the physician's office on Day 1.

Drug: Domperidone
Each participants will receive Domperidone 0.25 milligram per killogram (mg/kg) of body weight of oral suspension thrice daily for up to 7 days.

Experimental: Oral Rehydration Therapy + Placebo
Each participants will initiate ORT in the physician's office and placebo oral suspension thrice daily for up to 7 days.
Other: Oral Rehydration Therapy
Each participants will initiate ORT in the physician's office on Day 1.

Drug: Placebo
Each participants will receive placebo oral suspension thrice daily for up to 7 days.




Primary Outcome Measures :
  1. Percentage of Participants With No Vomiting Episode Within the First 48 Hours of the First Treatment Administration [ Time Frame: 48 Hours ]
    The vomiting episodes will be recorded for each participants in the eDiary.


Secondary Outcome Measures :
  1. Percentage of Participants 4 Years of Age or Older Who Have No Episode of Nausea Within the First 48 Hours of the First Treatment Administration [ Time Frame: 48 Hours ]
    The nausea episodes will be recorded in the eDiary.

  2. Number of Vomiting Episodes for Participants Within the 0 to 24 Hour, Greater Than (>) 24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration [ Time Frame: Up to Day 7 ]
    The vomiting episodes will be recorded for each participants in the eDiary.

  3. Number of Episodes of Nausea for Participants 4 Years of Age or Older Within the 0 to 24 Hour, >24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration [ Time Frame: Up to Day 7 ]
    The nausea episodes will be recorded in the eDiary.

  4. Percentage of Participants who Have No Episode of Vomiting Within the 0 to 24 Hour, >24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration [ Time Frame: Up to Day 7 ]
    The vomiting episodes will be recorded for each participants in the eDiary.

  5. Percentage of Participants 4 Years of Age or Older Who Have No Episode of Nausea Within the 0 to 24 Hour, >24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration [ Time Frame: Up to Day 7 ]
    The nausea episodes will be recorded in the eDiary.

  6. Percentage of Participants Who Have No Episode of Vomiting Within the 7 Day Treatment Period After the First Treatment Administration [ Time Frame: Day 7 ]
    The vomiting episodes will be recorded for each participants in the eDiary.

  7. Percentage of Participants 4 Years of Age or Older Who Have No Episode of Nausea Within the 7 Day Treatment Period After the First Treatment Administration [ Time Frame: Day 7 ]
    The nausea episodes will be recorded in the eDiary.

  8. Percentage of Participants Taking a Rescue Medication Within the 7 Day Treatment Period [ Time Frame: Day 7 ]
    If nausea, vomiting, or diarrhea worsens during the study and the investigator initiates rescue medication, the study medication will be discontinued.

  9. Percentage of Participants Stopping Study Medication Early Due to Vomiting-Free for 24 Hours Within the 7 Day Treatment Period [ Time Frame: Day 7 ]
    The vomiting episodes will be recorded for each participants in the eDiary.

  10. Time to Last Study Medication Within the 7 Day Treatment Period [ Time Frame: Day 7 ]
    Time taken to administer last study medication will be observed.

  11. Percentage of Participants Referred to an Emergency Room/Hospital for Treatment Within the 7 Day Treatment Period [ Time Frame: Day 7 ]
    If nausea, vomiting, or diarrhea worsens during the study and admits the participant to the hospital for IV fluids, the study medication will be discontinued.

  12. Time-to-Last Vomiting Within the 7 Day Period After the First Treatment Administration [ Time Frame: Day 7 ]
    The vomiting episodes will be recorded for each participants in the eDiary.

  13. Change From Baseline in Hydration Score at Day 2 [ Time Frame: Baseline and Day 2 ]
    The severity of dehydration will be assessed using the Dehydration Score Assessment. a) Children under 24 months of age with a score range 7 to 10 points have mild dehydration and children with a score range of 11 to 17 points have moderate dehydration (only children under 24 months of age are evaluated for tears). b) Children 24 months of age or older with a score range of 6 to 9 points have mild dehydration and children with a score range of 10 to 15 points have moderate dehydration. and c) Children under 24 months of age with scores of 18 or more and children 24 months of age or older with scores of 16 or more are considered to be severely dehydrated and are excluded from the study.

  14. Change From Baseline in Weight at Day 2 [ Time Frame: Baseline and Day 2 ]
    Weight will be measured to the nearest 100 grams in underwear (no diaper/nappy/training pants).

  15. Percentage of Participants With Diarrhea Within 0 to 24 Hour, >24 to 48 Hour, >48 Hour to 7 Day, and 0 Hour to 7 Day Periods After the First Successful Treatment Administration [ Time Frame: Up to Day 7 ]
    The diarrhea episodes will be recorded for each participant in the eDiary.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The participant presents with at least 3 episodes of non-bilious, non-bloody vomiting within the 24 hours prior to visiting the physician's office. The participant has at least 2 signs and symptoms other than vomiting consistent with acute gastroenteritis (AG) (example, fever, nausea, diarrhea, abdominal pain, bloating, or discomfort) within 3 hours prior to visiting the physician's office
  • The participant has mild-to-moderate dehydration
  • The participant had at least 1 episode of non-bloody diarrhea within the 24 hours prior to the visiting the physician's office

Exclusion Criteria:

  • The participant has severe dehydration or severe malnutrition
  • The participant who has vomiting and clinical symptoms for longer than 72 hours prior to the baseline physician's office visit
  • The participant needs intravenous (IV) fluid replacement
  • The participant has chronic severe diarrhea, a previous history of Helicobacter pylori infection or received treatment for H. pylori-induced gastritis, active peptic ulcer, celiac disease, Crohn's disease, ulcerative colitis, eosinophilic esophagitis, malabsorption, short bowel syndrome, post-viral gastroparesis, cyclic vomiting syndrome, or previous gastrointestinal surgery
  • The participant has upper respiratory symptoms such as cough, congestion, otitis media or pharyngitis

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): NCT02699385


Locations
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Austria
Gröbming, Austria
Salzburg, Austria
Vienna, Austria
Wien N/A, Austria
Belgium
Brussels, Belgium
Brussel, Belgium
Herbeumont, Belgium
Massemen, Belgium
Moorsel, Belgium
Russian Federation
Novosibirsk, Russian Federation
St. Petersburg, Russian Federation
St.Petersburg, Russian Federation
South Africa
Cape Town, South Africa
Durban, South Africa
Krugersdorp, South Africa
Middelburg, South Africa
Newtown, South Africa
Pietermaritzburg, South Africa
Pretoria, South Africa
Spain
Borriana, Spain
Gandia, Spain
Valencia, Spain
Vic, Spain
United Kingdom
Barnsley, United Kingdom
Ipswich, United Kingdom
Maidstone, United Kingdom
Middlesborough, United Kingdom
Nottingham, United Kingdom
Oldham, United Kingdom
Staffordshire, United Kingdom
Sutton In Ashfield, United Kingdom
Tunbridge Wells, United Kingdom
Sponsors and Collaborators
Janssen-Cilag International NV
Investigators
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Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT02699385    
Other Study ID Numbers: CR107501
R033812GTS3001 ( Other Identifier: Janssen-Cilag International NV )
2015-002923-24 ( EudraCT Number )
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen-Cilag International NV:
Gastroenteritis
Domperidone
Pediatric participants
Additional relevant MeSH terms:
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Gastroenteritis
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Domperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action