Cardiac Safety of Lansoprazole and Domperidon Combination

Safety Issues Clinical Trial

Official title:

Cardiac Safety Evaluation of Lansoprazole/Domperidone 30/30 mg Sustained Release Capsule Formulation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03355170
• Other study ID #: NEU-05.16
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 1, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: January 2023
• Source: Neutec Ar-Ge San ve Tic A.S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of current study is to compare safety and efficacy of lansoprazole/domperidone 30/30 mg sustained release capsules (brand name: Duolans) and lansoprazole 30 mg micropellet capsules (brand name: Lasotab) in GERD patients in terms of cardiac safety.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• GERD patients with BMI 18-33 kg/m2

• Patients with esophagitis class A-B according to Los Angeles classification

Exclusion Criteria:

• Patients whose long QT syndrome risk score > 3.

• Patients with family history of short or long QT syndrome.

• Patients with Barrett's stricture, gastric outlet obstruction, malignancy, gastrointestinal system bleeding or any other upper gastrointestinal system pathology.

• Patients whose Hiatus hernia is > 3 cm.

• Patients with uncontrolled or insulin dependent diabetes mellitus, symptomatic gallbladder stone, active or unhealed stomach or duodenum ulcer, Zollinger-Ellison syndrome, primary esophagus motility disorder, pancreatitis, inflammatory bowel disease, severe lung disease, chronic liver disease, uncontrolled kidney impairment, cancer (except skin cancer except melanoma), cerebrovascular disease, epilepsy.

• Patients with history of heart failure, ventricular tachycardia, ventricular fibrillation, cardiac arrest, Torsades de pointes, bradycardia, sinus node dysfunction, heart attack, long QTc (>460 ms).

• Patients taken PPIs or H2-blockers within 7 days and prokinetic drugs within 3 days before entering the study.

• Patients with major psychiatric disease.

• Alcoholism and drug use.

• Patients with pathologic laboratory tests; hemogram, sedimentation, CRP, thyroid functions tests, liver enzymes.

• Malabsorption.

• Immunosuppressive patients.

• Patients taken cortisone.

• Patients taken other drugs that prolong QT interval.

• Patients taken drugs that need gastric acid for optimal absorption; ketoconazole, iron salts, digoxin, ampicillin esters, anticoagulants, antineoplastic agents, prostaglandin analogues, sucralfate, atazanavir, theophylline, tacrolimus, fluvoxamine, rifampisin, nefazodone and aprepitant.

• Patients taken drugs carried with P-glycoprotein, indicated for heart diseases, AIDS/HIV or infection treatment.

• Pregnancy or breast-feeding.

• Patients taken drugs that may affect gastrointestinal system motility or acid release.

• History of abdominal surgery (hysterectomy, abdominal hernia repair, caesarean cases may be included; cholecystectomy have to be excluded).

• Patients with hypocalcemia and hypercalcemia

• Patients taken NSAII drugs (paracetamol may be used up to 2 gr/day).

• Patients taken antidepressants.

• Hypersensitivity to study drugs.

Related Conditions & MeSH terms

• Cardiac Event
• GERD
• Safety Issues

Intervention

Combination Product:
• Lansoprazole/Domperidone
Experimental

Drug:
• Lansoprazole
Active comparator

Locations

Country	Name	City	State
Turkey	Baskent University Hospital Gastroenterology Dep.	Adana
Turkey	Çukurova University Medical Faculty Cardiology Dep.	Adana
Turkey	Ankara University Medical Faculty Gastroenterology Dep.	Ankara
Turkey	Diskapi Research and Training Hospital Gastroenterology Dep.	Ankara
Turkey	Yüksek Ihtisas Research and Training Hospital Gastroenterology Dep.	Ankara
Turkey	Antalya Research and Training Hospital Gastroenterology Dep.	Antalya
Turkey	Balikesir University Medical Faculty Gastroenterology Dep.	Balikesir
Turkey	Gaziantep Sahinbey Research and Training Hospital Gastroenterology Dep.	Gaziantep
Turkey	Dr. Sadi Konuk Research and Training Hospital Gastroenterology Dep.	Istanbul
Turkey	Ümraniye Research and Training Hospital Gastroenterology Dep.	Istanbul
Turkey	Ege University Medical Faculty Gastroenterology Dep.	Izmir
Turkey	Tepecik Research and Training Hospital Gastroenterology Dep.	Izmir
Turkey	Celal Bayar University Medical Faculty Gastroenterology Dep.	Manisa
Turkey	Sitki Koçman University Medical Faculty Gastroenterology Dep.	Mugla
Turkey	Recep Tayyip Erdogan University Medical Faculty Gastroenterology Dep.	Rize
Turkey	Cumhuriyet University Medical Faculty Gastroenterology Dep.	Sivas

Sponsors (1)

Lead Sponsor	Collaborator
Neutec Ar-Ge San ve Tic A.S

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in QT and corrected QT (QTc) interval compared to baseline		8 weeks
Secondary	Change in upper gastrointestinal symptom severity index compared to baseline.		8 weeks