- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01251822
Comparator Study of PEG 3350 Versus Prucalopride in Females With Chronic Constipation
Double-dummy, Double-blind, Randomised, Parallel Group, Controlled Comparative Study of Polyethylene Glycol (PEG)Plus Electrolytes Versus Prucalopride in Females With Chronic Constipation Who Failed Adequate Relief With Laxatives
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Timisoara, Romania, RO-300244
- Pierrel Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient's written informed consent must be obtained prior to inclusion.
- Female patient aged 18 to 75 years with chronic constipation confirmed during the run-in period.
Patient with a history of self-reported chronic constipation for at least 6 months and not satisfied with laxatives in the past. Chronic constipation is defined by ROME III criteria (Drossman DA et al., 2006; Drossman DA, 2006) and characterised by:
<3 successful bowel movements per week and at least 1 of the following symptoms that has to have been present for at least 3 months prior to enrolment:
- Straining in at least 25% of defecations.
- Lumpy or hard stools in at least 25% of defecations.
- Sense of incomplete evacuation in at least 25% of defecations.
- Sensation of anorectal blockage in at least 25% of defecations.
- Manual manoeuvres to facilitate at least 25% of defecations.
- Less than 3 SCBMs during the last week of the run-in period.
- Willing and able to follow the entire procedure and to comply with study instructions.
Exclusion Criteria:
- History or evidence of organic disease in the large bowel, intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract such as Crohn's disease or ulcerative colitis, toxic megacolon or occlusive or subocclusive syndrome.
- Abdominal pain of unknown cause.
- Known allergy to PEG 3350, prucalopride or known hypersensitivity to any of the other study medication ingredients.
- Drug or alcohol abuse (recent history or within previous 12 months).
- Pregnant or lactating female.
- Severe or acute disease within the last 2 weeks prior to the start of the study based on Investigator's judgement.
Use of:
- Any oral purgatives/laxatives and prokinetics within the last 14 days prior to dosing and during the study.
- Any opioids, anticholinergics, tricyclic anti-depressants, monoamine-oxidase inhibitors or iron preparations within the last 4 weeks prior to dosing.
- Any calcium-antagonists, beta-blockers or diuretics within the last 4 weeks prior to dosing.
- Other investigational drugs or prescribed medications affecting gastrointestinal function such as antispasmodics, drugs affecting motility (e.g. erythromycin), anthraquinones, ondansetron or other 5-hydroxytryptamine-3 (5-HT3) antagonists.
- Any other medication which in the opinion of the investigator could interfere with the principal function of the gastrointestinal tract.
- Insufficient documentation of chronic constipation during the run-in period.
- Diarrhoea during the run-in period.
- Anamnesis/medical history with clinically relevant findings in the gastrointestinal tract during proctoscopy, colonoscopy, sigmoidoscopy or computer tomography, or any other condition which in the Investigator's opinion, may put the patient at significant risk, may confound the study results or may interfere significantly with the results of the study.
- Participation in another clinical study of drugs or devices parallel to or less than 90 days before study entry or previous participation in this study.
- Gastrointestinal surgery within the last 6 months prior to the start of the study.
- Malignant tumours within the last 5 years prior to the start of the study.
- Uncontrolled blood pressure or terminal cardiac, liver and/or kidney diseases.
- Patient with diagnosis or evidence of the following diseases: hypothyroidism, diabetes mellitus, porphyria, pituitary gland insufficiency, pheochromocytoma, glucagonoma, neurological diseases (e.g. Hirschprung diseases, neurofibromatosis, Chagas diseases, stroke, autonomous neuropathy, intestinal pseudo-obstruction, multiple sclerosis, medullar injury, Parkinson diseases, Shy-Drager syndrome), collagenosis, vasculitis, myopathy (e.g. sclerodermatitis, amyloidosis, dermatomyositis), intoxication with heavy metals (e.g. lead, phosphorus, arsenic, mercury).
- Patients with known HIV infection.
- Woman of childbearing potential, who is not using and not willing to use medically reliable methods of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless she is surgically sterilised/hysterectomised or any other criteria considered sufficiently reliable by the Investigator in individual cases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PEG 3350
PEG 3350 plus electrolytes in solution plus placebo tablets
|
Each sachet of PEG 3350 is dissolved in 125 mL of water.
Patients receive two sachets of PEG 3350 plus electrolytes followed by two placebo tablets for the first 14 days, after which dosage adjustment is permitted, according to effect.
Each patient is treated for 28 days in total.
|
Active Comparator: Prucalopride
Prucalopride tablets plus placebo solution
|
Patients less than 65 years of age receive a solution containing two sachets of reconstituted placebo followed by two prucalopride 1 mg tablets for 28 days. Patients more than 65 years of age receive a solution containing two sachets of reconstituted placebo followed by one prucalopride 1 mg tablet and one placebo tablet for 28 days. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of spontaneous bowel movements
Time Frame: Days 22 to 28 of treatment
|
Proportion of patients having normal number of spontaneous bowel movements during the last treatment week.
|
Days 22 to 28 of treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rodica Cinci, Prof Dr, Pierrel Research
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEG-01/2010 (PRUC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Constipation
-
usMIMA S.L.CompletedConstipation | Constipation Chronic Idiopathic | Constipation; NeurogenicSpain, United Kingdom
-
AbbVieIronwood Pharmaceuticals, Inc.RecruitingFunctional Constipation (FC) | Chronic Idiopathic Constipation (CIC)United States, United Kingdom, Bulgaria, Netherlands
-
usMIMA S.L.University of York; County Durham and Darlington NHS Foundation TrustNot yet recruitingConstipation | Constipation-predominant Irritable Bowel Syndrome | Constipation - Functional | Constipation Chronic Idiopathic | Constipation; Neurogenic
-
Institute of Medical Sciences and SUM HospitalNot yet recruitingFunctional Constipation | Constipation - Functional | Constipation Chronic Idiopathic | Fecal Impaction | Pediatric Functional ConstipationIndia
-
SK Life Science, Inc.CompletedChronic Constipation | Functional ConstipationUnited States
-
Cairo UniversityUnknownChronic Idiopathic Constipation | Functional ConstipationEgypt
-
ProgenaBiomeRecruitingConstipation | Constipation - Functional | Constipation Chronic Idiopathic | Constipation (Excl Faecal Impaction)United States
-
Pamukkale UniversityRecruiting
-
Shanghai University of Traditional Chinese MedicineLonghua Hospital; Shanghai Municipal Hospital of Traditional Chinese MedicineRecruiting
-
Universidade Nova de LisboaCINTESIS - Center for Health Technology and Services ResearchRecruiting
Clinical Trials on PEG 3350 plus electrolytes
-
BayerCompleted
-
Temple UniversityCompletedColon CancerUnited States
-
Indiana UniversityRecruiting
-
Fundación Pública Andaluza para la gestión de la...Unknown
-
Instituto Nacional de Ciencias Medicas y Nutricion...CompletedBowel Preparation for ColonoscopyMexico
-
ColonaryConcepts LLCCompleted
-
University of MichiganRecruitingIrritable Bowel Syndrome Characterized by ConstipationUnited States
-
Children's Hospital of PhiladelphiaFood and Drug Administration (FDA)Recruiting
-
Institute of Medical Sciences and SUM HospitalNot yet recruitingFunctional Constipation | Constipation - Functional | Constipation Chronic Idiopathic | Fecal Impaction | Pediatric Functional ConstipationIndia