CLINICAL STUDY, DOUBLE-BLIND, RANDOMIZED TO EVALUATE THE EFFICACY AND SAFETY OF SODIUM PICOSULPHATE 2.5MG /100ML (MARKOS PURGANT LEMONADE), PLACEBO CONTROLLED IN PATIENTS WITH FUNCTIONAL CHRONIC CONSTIPATIO
- Conditions
- K599 Functional intestinal disorder, unspecifiedFunctional intestinal disorder, unspecifiedK599
- Registration Number
- PER-005-21
- Lead Sponsor
- ABORATORIOS FARMACEUTICOS MARKOS S.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrollment closed
- Sex
- All
- Target Recruitment
- 165
3. Able and willing to complete a log journal.
4. Written informed consent signed and dated prior to enrollment in the study in accordance with GCP and local legislation
1. Participants of both sexes between 18 to 60 years of age
2. Have a diagnosis of functional chronic constipation, according to their medical history as defined by the Rome IV diagnostic criteria. Criteria met during the last 3 months with onset of symptoms at least 6 months before diagnosis.
a) Presence of two or more of the following criteria:
• Excessive straining in at least 25% of stools
• Hard stools in at least 25% of stools (Bristol type 1-2)
• Feeling of incomplete evacuation in at least 25% of stools
• Anorectal blockage or blockage sensation in at least 25% of bowel movements
• Manual maneuvers to facilitate defecation in at least 25% of bowel movements
• Less than three complete spontaneous bowel movements a week
b) The presence of liquid stools is rare without the use of laxatives
c) There should not be sufficient criteria for the diagnosis of Irritable Bowel Syndrome
9. Patients whose concomitant therapy includes an opioid medication (eg morphine, codeine) or anticholinergics
10. Patients who are unwilling to discontinue the use of the prohibited concomitant therapy
11. Pregnant or lactating women
12. Participate concomitantly in another trial
13. Drug or alcohol abuse
14. Concomitant use of antibiotics
15. Therapy with other drugs of similar action within 02 weeks before the screening visit
16. Use of potassium-sparing diuretics or potassium supplements, chronic or excessive use of laxatives can reduce the serum concentration of potassium by promoting an excessive loss of potassium in the intestinal tract.
17. Use of Antiarrhythmics (quinidine type): Sotalol, amiodarone, vincamine, digitalis.
18. Inflammatory bowel disease (ulcerative colitis, Crohn's disease).
Patient with a history or clinical suspicion at the time of medical evaluation of the following entities:
1. Eating disorders such as anorexia nervosa and bulimia, as a cause of excessive use of laxatives.
2. Patients whose constipation is caused by a primary organic disease of the colon or pelvic floor.
3. Patients with metabolic disorders, neurological disorders, severe psychiatric disorders, or any other significant or intercurrent illness (eg, abdominal / gastrointestinal surgery) that, in the opinion of the investigators, would interfere with participation in the trial.
4. Patients with a disability that restricts their spontaneous mobility (eg, in a wheelchair or in bed).
5. Patients with known hypersensitivity to sodium picosulfate, bisacodyl, or any other ingredient in the study medication.
6. Patients with ileus, intestinal obstruction, acute surgical abdominal conditions (such as acute appendicitis and acute inflammatory bowel diseases) or severe dehydration
7. Patients with anal fissures or ulcerative proctitis with mucosal damage.
8. Patients with kno
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Self Report / e-CRF<br> NAME OF THE RESULT: Average number of CSBMs per week<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: During study treatment (4 weeks)
- Secondary Outcome Measures
Name Time Method