Sysemic sclerosis with gastroenteric involvement (constipation) MedDRA version: 14.1 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: RESOLOR*28CPR RIV 2MG
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PRUCALOPRIDE SUCCINATE
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number
Sponsors
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: SSc diagnosis according to (12) - Female gender (not breast-feeding, not pregnant) - Age > 18 years - Mild-to-moderate symptoms of gastro-esophageal reflux disease on a 4-grade modified Likert scale (grade 1 and 2) - Mild-to-severe constipation symptoms on a 5-grade modified Likert scale (grade 1 to 3) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients enrolled in other clinical trials - Current use or recent use (<1 weeks) of prokinetics - Current use or recent use (<1 weeks) of laxaitives - Severe symptoms (grade 3) of gastro-esophageal reflux disease on a 4-grade modified Likert scale - Very severe constipation symptoms (grade 4) on a 5-grade modified Likert scale - Renal insufficiency - Hepatic insufficiency Child-Pugh class C - Inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Improve sponaneous bovel movements in patients with constipation secondary to systemic sclerosis;Secondary Objective: Reduce the frequency and intensity of gasto-esophageal reflux sympoms and the quality of life.;Primary end point(s): Reduction in the inesinal transit time as assessed by he lactulose breath test;Timepoint(s) of evaluation of this end point: 12 weeks/pazient | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Reduction in the time to gastric emptying as assessed by the 13-C octanoic acid breath test - Improvement of the quality of life as assessed by the UCLA scleroderma clinical trial gastrointestinal tract instrument, reflux, abdominal distension and constipation subitems - Change in the number of spontaneous complete bowel movements (SCBM) per week with respect to baseline. - Self-reported efficacy on a 5-point modified Likert scale. - Mean number of laxative tablets used as a rescue medication for constipation. - Mean number of Gaviscon chewable tablets used as rescue medication for reflux disease;Timepoint(s) of evaluation of this end point: 12 weeks/pazient | — |
Countries
Italy
Contacts
Public ContactU.O.ALLERGOLOGIA-IMMUNOLOGIA
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
Outcome results
None listed