Comparator Study of PEG 3350 Versus Prucalopride in Females With Chronic Constipation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norgine
ClinicalTrials.gov Identifier:
NCT01251822
First received: November 30, 2010
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

This study is to compare the efficacy and safety of polyethylene glycol (PEG) 3350 with that of prucalopride in the treatment of chronic constipation in females. A total of 240 patients will be randomly allocated to treatment with one or the other agent. The study consists of a 14-day run-in period, with treatment subsequently administered for 28 days on a daily basis. During the study, patients will fill in a stool diary, samples of faeces will be collected, and colonic transit time will be measured prior to therapy, and from days 22 to 28 of treatment. The proportion of patients with normalised bowel movements (three or more spontaneous movements) during the last week of the study (days 22 to 28 of treatment) will be compared between treatments.


Condition Intervention Phase
Constipation
Drug: PEG 3350 plus electrolytes
Drug: Prucalopride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Norgine:

Primary Outcome Measures:
  • Number of spontaneous bowel movements [ Time Frame: Days 22 to 28 of treatment ] [ Designated as safety issue: No ]
    Proportion of patients having normal number of spontaneous bowel movements during the last treatment week.


Enrollment: 240
Study Start Date: November 2010
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEG 3350
PEG 3350 plus electrolytes in solution plus placebo tablets
Drug: PEG 3350 plus electrolytes
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
Drug: Prucalopride

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.


  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient's written informed consent must be obtained prior to inclusion.
  2. Female patient aged 18 to 75 years with chronic constipation confirmed during the run-in period.
  3. 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.
  4. Less than 3 SCBMs during the last week of the run-in period.
  5. Willing and able to follow the entire procedure and to comply with study instructions.

Exclusion Criteria:

  1. 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.
  2. Abdominal pain of unknown cause.
  3. Known allergy to PEG 3350, prucalopride or known hypersensitivity to any of the other study medication ingredients.
  4. Drug or alcohol abuse (recent history or within previous 12 months).
  5. Pregnant or lactating female.
  6. Severe or acute disease within the last 2 weeks prior to the start of the study based on Investigator's judgement.
  7. 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.
  8. Insufficient documentation of chronic constipation during the run-in period.
  9. Diarrhoea during the run-in period.
  10. 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.
  11. 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.
  12. Gastrointestinal surgery within the last 6 months prior to the start of the study.
  13. Malignant tumours within the last 5 years prior to the start of the study.
  14. Uncontrolled blood pressure or terminal cardiac, liver and/or kidney diseases.
  15. 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).
  16. Patients with known HIV infection.
  17. 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01251822

Locations
Romania
Pierrel Research
Timisoara, Romania, RO-300244
Sponsors and Collaborators
Norgine
Investigators
Principal Investigator: Rodica Cinci, Prof Dr Pierrel Research
  More Information

No publications provided by Norgine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Norgine
ClinicalTrials.gov Identifier: NCT01251822     History of Changes
Other Study ID Numbers: PEG-01/2010 (PRUC)
Study First Received: November 30, 2010
Last Updated: August 30, 2012
Health Authority: Romania: Ministry of Public Health

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014