The primary objective of this trial is to investigate the laxative effect of Lysisstílar (Free Fatty Acids suppositories) as compared to Klyx. Participants are children aged 1 year old to 17 years diagnosed with acute constipation with history and examination.
Conditions
Interventions
Product Name: Lýsisstílar fyrir börn
Product Code: 30FFA
Pharmaceutical Form: Suppository
INN or Proposed INN: Free fatty acids
Current Sponsor code: HF001
Concentration unit: % (W/W) percent weight/w
Sponsors
Lipid Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Otherwise healthy children from 1 year old to 17 years old, including mentally and physically disabled children attending the A&E for children and diagnosed with acute constipation according to history, examination and abdominal X-ray if needed. This includes patients with history of rectal bleeding, anal fissure, anal stenosis, haemorrhoids or rectal itching and have not used rectally applied medicines for 7 days prior to inclution into the study. Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Individuals younger than 1y old and 18 years of age and older, pregnancy, breastfeeding, diarrhoea unless it is bypass due to constipation, active bleeding from rectum. Known inflammatory disease in rectum or rectosigmoid colon. Expected enterocolitis or other active inflammation. Patients receiving rectally administered drugs within 7 days prior to inclusion. Patients using anticoagulants. Other medication is at the discretion of the investigating physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the laxative effects of lýsisstílar as compared to Klyx rectal solution in peadiatric population. ;Secondary Objective: Monitor safety of the participants.;Primary end point(s): Primary endpoint is efficacy of Lýsisstílar compared to Klyx in children diagnosed with acute constipation.;Timepoint(s) of evaluation of this end point: The trial subject's will be monitored after administration of the medicines until their constipation has been resolved. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety of the patients.;Timepoint(s) of evaluation of this end point: Patients will be monitored until their constipation is resolved. Possible side effects of the medicines will be monitored during that time in peticular any bleeding and mucose formation. | — |
Countries
Iceland
Contacts
Public ContactFramkvæmdastjóri
Lipid Pharmaceuticals
Outcome results
None listed