Occasional constipation MedDRA version: 16.1 Level: PT Classification code 10010774 Term: Constipation System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: LAXANTE FIBRA
Pharmaceutical Form: Powder and solvent for oral suspension
INN or Proposed INN: Plantago ovata seed coat
Other descriptive name: PLANTAGO OVATA SEED COAT
Concentration uni
Sponsors
GeiserPHARMA SL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects of both sexes (men or women). 2. Between the ages of 18 and 60 years. 3. Occasional constipation, since 6 weeks ago 4. Appropriate cultural level and understanding of the clinical trial. 5. Agree to participate voluntarily in the clinical trial and give their informed consent in writing 6. Not treated for constipation (medication or nutritional supplement) in a period of 7 days before the treatment 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 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy and lactation 2. Be taking other laxatives 3. Functional constipation (according to criteria Rome III) 4. Gastrointestinal diseases severe acute in a prior period of 3 months to the participation in the clinical trial, or suffering from chronic gastrointestinal illnesses such as (intestinal obstruction, stenosis of the tract di gestivo, fecal impaction, atony of colon, ileus, abdominal pain, nausea or vomiting, diabetes mellitus difficult to regulate, undiagnosed rectal bleeding, inability to have a bowel movement after use of a laxative, patients with diseases of the esophagus, as Barrett's Esophagus and gastro-oesophageal reflux...) 5. Subjects with allergy or hypersensitivity to any component of the product under study (excipients or API) 6. Patients with swallowing difficulty. 7. To present acetyl salicylic acid allergy 8. To present situation of 'immobility' and previous episodes of 'faecal impaction'
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of 2 formulations in terms of weekly stools production in patients with occasional constipation;Secondary Objective: - To evaluate the quality of the stools - To evaluate the organoleptic and acceptability properties and subjective efficacy of the product. - To evaluate the safety of a laxative formula fibre;Primary end point(s): Number of weekly stools (weekly stools production);Timepoint(s) of evaluation of this end point: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 7 days;Secondary end point(s): - The time that it takes to achieve a pharmacological effect. (the time that it takes to go from 3.5weekly stools) - Quality of stools (number and consitency) according to Bristol scale - Evaluation of the organoleptic and acceptability properties and subjective efficacy, through the satisfaction survey. Score from 0 to 4 of each of the items proposed in the survey -Presence of pain associated with defecation (through analysis of visual analog scale). - Assessment of the adverse events | — |
Countries
Spain
Contacts
Public ContactTamara Cordero
GeiserPHARMA SL
Outcome results
None listed