Multisite, open, randomized, parallel and controlled clinical trial, to evaluate the efficacy and safety of a laxative fiber formula compared to Plantaben on objective and subjective parameters of the occasional constipatio

• Conditions: Occasional constipation; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]; MedDRA version: 16.1Level: PTClassification code 10010774Term: ConstipationSystem Organ Class: 10017947 - Gastrointestinal disorders

• Registration Number: EUCTR2012-004293-26-ES
• Lead Sponsor: GeiserPHARMA S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-29
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 0

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

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'

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified