Evaluación del impacto de LacTEST en el pensamiento diagnóstico y en el manejo terapéutico del paciente, y de reproducibilidad (Test-Retest), para el diagnóstico de la hipolactasia en adultos y población anciana que presenten síntomas clínicos de intolerancia a la lactosa.
Conditions
Interventions
Trade Name: LacTEST 0,45g
Product Name: Gaxilose
Pharmaceutical Form: Powder and solvent for oral solution
INN or Proposed INN: GAXILOSE
Other descriptive name: LacTEST
Concentration unit: g gram(s)
C
Sponsors
Venter Pharma S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults of either sex, between 18 and 70 years old. 2. Capacity for understanding and giving the informed consent to participate in this study. 3. Patients with clinical suggestive of lactose intolerance, primary or secondary, who have not been diagnosed and that fulfil the requirements allowed by the Gaxilose summary of product characteristics Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 144 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 144
Exclusion criteria
Exclusion criteria: 1. Pregnant women or breast-feeding women. 2. Unable or reticent to give the informed consent or to comply with the study?s requirements. 3. Severe renal insufficiency. 4. Portal hypertension: ascites, cirrhosis. 5. Medical records of total gastrectomy and/or vagotomy. 6. Patients diagnosed with myxedema. 7. Patients with Diabetes Mellitus. 8. Patients who are participating or have participated in any clinical trial within the 3 months previous to their inclusion in the study. 9. Patients who are drug abuse consumers. 10. Patients under treatment with antibiotics, sulphamides and antiparasitics, who cannot suspend the treatments 7 days prior to the performance of the hydrogen breath test. 11. Patients with any recognized and already existing disorder that might interfere with the any of the lactose intolerance diagnosis tests. 12. Patients who have taken aspirin of indomethacin in the 48h preceding the performance of the Gaxilose test. 13. Patients with glomerular filtration rate (GFR) less 90 ml/min/1.73 m2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate non ?inferiority of Gaxilose test, compared with Hydrogen Breath Test (HBT) using a validated method, of the impact on diagnostic thinking for the diagnosis of hypolactasia.;Secondary Objective: 1. to demonstrate non ?inferiority of Gaxilose test, compared with Hydrogen Breath Test (HBT), on the impact on patient management for the diagnosis of hypolactasia; 2. to demonstrate Gaxilose test reproducibility with urine accumulated from 0-4h after Gaxilose administration; 3. to demonstrate Gaxilose test reproducibility with urine accumulated from 0-5h after Gaxilose administration; 4. safety assessments.;Primary end point(s): To analyse the change in diagnostic certainty and in patient management consequent to HBT or Gaxilose test implementation in the clinical practice.;Timepoint(s) of evaluation of this end point: - Visual Analogue Scale (VAS) pre-test and post-test. - Intended management pre-test and post-test questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Spain
Contacts
Public ContactPaz González
Pivotal, S.L.
Outcome results
None listed