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GastroenteritisPhase 3NCT02699385

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

A Phase 3 study testing Oral Rehydration Therapy and Domperidone in people with Gastroenteritis, run by Janssen-Cilag International NV at 29 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 months to 12 years
Conditions the study is for
Gastroenteritis
What is being tested?
Oral Rehydration Therapy and Domperidone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
29 sitesin 6 countries
Study dates
7 Dec 2015to 3 Aug 2017
Phase
Phase 3
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 6 months to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

29 sites in 6 countries.

29 sites in 6 countries

United Kingdom9 sites

  • Study site

    Barnsley

  • Study site

    Ipswich

  • Study site

    Maidstone

  • Study site

    Middlesbrough

  • Study site

    Nottingham

  • Study site

    Oldham

  • Study site

    Royal Tunbridge Wells

  • Study site

    Staffordshire

  • Study site

    Sutton in Ashfield

Other trials in United Kingdom

South Africa7 sites

  • Study site

    Cape Town

  • Study site

    Durban

  • Study site

    Krugersdorp

  • Study site

    Middelburg

  • Study site

    Newtown

  • Study site

    Pietermaritzburg

  • Study site

    Pretoria

Other trials in South Africa

Belgium4 sites

  • Study site

    Brussels

  • Study site

    Herbeumont

  • Study site

    Massemen

  • Study site

    Moorsel

Other trials in Belgium

Spain4 sites

  • Study site

    Burriana

  • Study site

    Gandia

  • Study site

    Valencia

  • Study site

    Vic

Other trials in Spain

Austria3 sites

  • Study site

    Gröbming

  • Study site

    Salzburg

  • Study site

    Vienna

Other trials in Austria

Russia2 sites

  • Study site

    Novosibirsk

  • Study site

    Saint Petersburg

Other trials in Russia

About this study

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

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.

Read the 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.

Conditions
Gastroenteritis
Being tested
Oral Rehydration Therapy, Domperidone, Placebo
Keywords
Gastroenteritis, Domperidone, Pediatric participants
Medical subject headings
Gastroenteritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral Rehydration TherapyOther

    Each participants will initiate ORT in the physician's office on Day 1.

  • DomperidoneDrug

    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.

  • PlaceboDrug

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

Study groups in NCT02699385
Study groupRoleWhat they receive
Oral Rehydration Therapy (ORT) + DomperidoneExperimentalEach 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.
Receives: Other: Oral Rehydration Therapy; Drug: Domperidone
Oral Rehydration Therapy + PlaceboExperimentalEach participants will initiate ORT in the physician's office and placebo oral suspension thrice daily for up to 7 days.
Receives: Other: Oral Rehydration Therapy; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With No Vomiting Episode Within the First 48 Hours of the First Treatment Administration

    The vomiting episodes will be recorded for each participants in the eDiary.

    Measured: 48 Hours

Secondary outcomes (15)

  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

    The nausea episodes will be recorded in the eDiary.

    Measured: 48 Hours

  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

    The vomiting episodes will be recorded for each participants in the eDiary.

    Measured: Up to Day 7

  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

    The nausea episodes will be recorded in the eDiary.

    Measured: Up to Day 7

  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

    The vomiting episodes will be recorded for each participants in the eDiary.

    Measured: Up to Day 7

  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

    The nausea episodes will be recorded in the eDiary.

    Measured: Up to Day 7

  6. Percentage of Participants Who Have No Episode of Vomiting Within the 7 Day Treatment Period After the First Treatment Administration

    The vomiting episodes will be recorded for each participants in the eDiary.

    Measured: Day 7

  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

    The nausea episodes will be recorded in the eDiary.

    Measured: Day 7

  8. Percentage of Participants Taking a Rescue Medication Within the 7 Day Treatment Period

    If nausea, vomiting, or diarrhea worsens during the study and the investigator initiates rescue medication, the study medication will be discontinued.

    Measured: Day 7

  9. Percentage of Participants Stopping Study Medication Early Due to Vomiting-Free for 24 Hours Within the 7 Day Treatment Period

    The vomiting episodes will be recorded for each participants in the eDiary.

    Measured: Day 7

  10. Time to Last Study Medication Within the 7 Day Treatment Period

    Time taken to administer last study medication will be observed.

    Measured: Day 7

  11. Percentage of Participants Referred to an Emergency Room/Hospital for Treatment Within the 7 Day Treatment Period

    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.

    Measured: Day 7

  12. Time-to-Last Vomiting Within the 7 Day Period After the First Treatment Administration

    The vomiting episodes will be recorded for each participants in the eDiary.

    Measured: Day 7

  13. Change From Baseline in Hydration Score at 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.

    Measured: Baseline and Day 2

  14. Change From Baseline in Weight at Day 2

    Weight will be measured to the nearest 100 grams in underwear (no diaper/nappy/training pants).

    Measured: Baseline and Day 2

  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

    The diarrhea episodes will be recorded for each participant in the eDiary.

    Measured: Up to Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2016 (estimated)
  2. Study start7 Dec 2015
  3. Primary completion3 Aug 2017
  4. Study completion3 Aug 2017

Why it stopped: Study prematurely terminated upon recommendation of IDMC due to lack of efficacy.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02699385
Sponsor's protocol ID
CR107501
Other IDs
R033812GTS3001, 2015-002923-24, 2015
Status last verified
Mar 2019
First submitted
15 Feb 2016
Last updated
20 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Leitz G, Hu P, Appiani C, Li Q, Mitha E, Garces-Sanchez M, Gupta R. Safety and Efficacy of Low-dose Domperidone for Treating Nausea and Vomiting Due to Acute Gastroenteritis in Children. J Pediatr Gastroenterol Nutr. 2019 Oct;69(4):425-430. doi: 10.1097/MPG.0000000000002409.

    PubMed 31181017

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oral Rehydration Therapy and Domperidone in people with Gastroenteritis, run by Janssen-Cilag International NV at 29 sites in 6 countries.

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 5 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: stopped early, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United Kingdom, South Africa, Belgium, Spain, Austria and 1 more country. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study prematurely terminated upon recommendation of IDMC due to lack of efficacy.). Results are not available in the source record.

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?

Percentage of Participants With No Vomiting Episode Within the First 48 Hours of the First Treatment Administration (time frame: 48 Hours). 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 NCT02699385, which also lists 1 linked publication.

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 20 Mar 2019.

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