Trials Sponsors Conditions Drugs Pricing

Conditions

Type 1 Diabetic Type 1 Diabetic patients

Outcome Measures

Primary Outcomes (1)

Percentages of time spent within the TIR (Time In Range) glycemic target range (70-180 mg/dL)
The difference of percentages of time spent within the TIR glycemic target range (70-180 mg/dL) recorded over 14 days under prokinetic treatment (domperidone) or placebo in T1D patients with gastroparesis and inadequate glycemic control
14 days after domperidone or placebo

Secondary Outcomes (4)

Variation in glycemic control criteria : HbA1c assay
14 days after domperidone of placebo
Variation in glycemic control criteria : Plasma fructosamine assay
14 days after domperidone of placebo
Variation in glycemic control criteria : Insulin dose
14 days after domperidone of placebo
Safety Outcome : AE and SAE Occurrence
105 days

Study Arms (2)

Domperidone then placebo

EXPERIMENTAL

Domperidone 10 mg, 3/days during 28 days, - wash-out (21 days) then placebo 3/days during 28 days

Drug: Domperidone 10mgDrug: PlaceboDiagnostic Test: gastric emptying test

Placebo then Domperidone

EXPERIMENTAL

Placebo 3/days during 28 days - wash-out (21 days) - then Domperidone 10 mg, 3/days during 28 days

Drug: Domperidone 10mgDrug: PlaceboDiagnostic Test: gastric emptying test

Interventions

Domperidone 10mgDrug

30 mg per day for 21 days

Domperidone then placeboPlacebo then Domperidone

PlaceboDrug

3 per day for 21 days

Domperidone then placeboPlacebo then Domperidone

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
DOMPÉRIDONE ARROW 10 mg, comprimé pelliculé
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

DOMPÉRIDONE ARROW 10 mg, comprimé pelliculé
Named ingredient: Domperidone
View registry record

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female ≥ 18 years and \<75 years
Known type 1 diabetic patients for \> 5 years treated with multi-injection insulin regimen or insulin pump with continuous interstitial glucose recording device (CGM)

Sponsors & Collaborators

University Hospital, Rouen
Otherlead
Centre Hospitalier Universitaire Rouen
Type not reportedlead

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Sites (6)

CHU Amiens

Amiens, France

Rachel DESAILLOUD, PrCONTACT322455478 ext. +33 desailloud.rachel@chu-amiens.fr

CHU de CAEN

Caen, France

Michael JOUBERT, PrCONTACT231064575 ext. +33 joubert-m@chu-caen.fr

CH Dieppe

Dieppe, France

Caroline FOLOPPE, MDCONTACT232147557 ext. +33

MeSH Terms

Interventions

Domperidone

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Gaetan PREVOST, Pr

CONTACT

232889061 gaetan.prevost@chu-rouen.fr

Armelle Guidotti

CONTACT

232888265

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 15, 2024

First Posted

November 19, 2024

Study Start

March 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

June 1, 2029

You may not qualify if:

Type 2 diabetic patients
Patients with CGM\<70%
Type 1 diabetic patients with glycemic target TIR (70-180 mg/dL) \< 40%
Patients with renal insufficiency (GFR\<60 ml/min according to CKD-EPI formula),
Patients with contraindications to DOMPERIDONE ARROW 10 mg film-coated tablet:
Hypersensitivity to the active substance or to one of the excipients
Pituitary prolactin tumor (prolactinoma)
Underlying heart disease such as congestive heart failure (NYHA stage ≥2),
Kalemia less than 3.7 mmol/L or greater than 5.5 mmol/L,
Magnesemia less than 0.7 mmol/L
Hepatic impairment (TGO, TGP, GGT\>2N, TP\<70% (unless on anticoagulant))
Known prolongation of cardiac conduction intervals, notably the QTc interval (QTc greater than 440 ms for men and greater than 460 ms for women)
Use of drugs that prolong the QTc interval (class IA antiarrhythmics (e.g. disopyramide, hydroquinidine, quinidine) and class III antiarrhythmics (e.g. amiodarone, dofetilide, dronedarone, ibutilide, sotalol), certain antipsychotics (e.g. haloperidol, pimozide, sertindole), certain antidepressants (e.g. citalopram, escitalopram), certain antibiotics (e.g. erythromycin, levifloxacin, moxifloxacin, spiramycin), certain antifungals (e.g. pentamidine, fluconazole), certain antimalarial drugs (in particular halofantrine, lumefantrine), certain digestive drugs (e.g. cisapride, dolasetron, prucalopride), certain antihistamines (e.g. mequitazine, mizolastine), certain anticancer drugs (e.g. toremifene, vandetanib, vincamine), certain other drugs (e.g. bepridil, diphemanil, methadone), apomorphine (unless the benefit of concomitant administration outweighs the risks, and only if the precautions recommended for concomitant administration are strictly observed).
Taking levodopa
Use of drugs that are potent or moderate inhibitors of CYP3A4: antiproteases, systemic azole antifungals, certain macrolide antibiotics (clarithromycin, telithromycin, azithromycin, roxithromycin, etc.), diltiazem, verapamil, etc.
+10 more criteria

Efficacy of Domperidone (a Prokinetic Agent) on Time in Range in Digestively Asymptomatic Type I Diabetic Patients With Delayed Gastric Emptying (Gastro-TIR)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Domperidone then placebo

Placebo then Domperidone

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations

Efficacy of Domperidone (a Prokinetic Agent) on Time in Range in Digestively Asymptomatic Type I Diabetic Patients With Delayed Gastric Emptying (Gastro-TIR)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Domperidone then placebo

Placebo then Domperidone

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations