Constipation
Conditions
Interventions
Product Name: Lýsisstílar 30%
Product Code: 30FFA
Pharmaceutical Form: Suppository
Pharmaceutical form of the placebo: Suppository
Route of administration of the placebo: Rectal use
Product Name: Lýs
Sponsors
Lipid Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Otherwise healthy individuals, 18 years old and older visiting gastroenterologists and diagnosed with constipation Signed informed consent form 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 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Pregnant women and breastfeeding women. Individuals suffering from diarrhoea unless it is bypass due to constipation. Individuals with active bleeding from rectum or sigmoidcolon. Individuals with known inflammatory disease at rectum or sigmoidcolon. Individuals that have used rectally administered drugs e.g. suppositories and klysma within a week from entering the study. Individuals using anticoagulants. Suspected cancer in rectum. Other medication is at the discretion of the investigating physicians. Individuals incapable of giving consent. Individuals who reject participation. Individuals who have participated in a clinical trial within 6 months prior to entering the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the laxative effects of suppositories containing 30% and 40% free fatty acids and compare to the effects of placebo;Secondary Objective: Monitor safety of the participants;Primary end point(s): Bowel opening after first, second or both applications of the suppositories containing free fatty acids;Timepoint(s) of evaluation of this end point: Within 1 hour after application of the suppositories. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Monitoring of safety;Timepoint(s) of evaluation of this end point: Within 1 hour after application of the suppositories. | — |
Countries
Iceland
Contacts
Public ContactPrincipal Investigator
Lipid Pharmaceuticals
Outcome results
None listed