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

NCT01251822 | Completed Phase 3

• 1 other identifier: PEG-01/2010 (PRUC)
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• Number of spontaneous bowel movements

  Proportion of patients having normal number of spontaneous bowel movements during the last treatment week.

  Days 22 to 28 of treatment

Study Arms (2)

PEG 3350

EXPERIMENTAL

PEG 3350 plus electrolytes in solution plus placebo tablets

Drug: PEG 3350 plus electrolytes

Prucalopride

ACTIVE COMPARATOR

Prucalopride tablets plus placebo solution

Drug: Prucalopride

Interventions

PEG 3350 plus electrolytes DRUG

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.

PEG 3350

Prucalopride DRUG

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.

Prucalopride

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norgine: lead

Study Sites (1)

Pierrel Research

Timișoara, RO-300244, Romania

Location

Related Publications (1)

• Cinca R, Chera D, Gruss HJ, Halphen M. Randomised clinical trial: macrogol/PEG 3350+electrolytes versus prucalopride in the treatment of chronic constipation -- a comparison in a controlled environment. Aliment Pharmacol Ther. 2013 May;37(9):876-86. doi: 10.1111/apt.12278. Epub 2013 Mar 11.

  PMID: 23480216 DERIVED

MeSH Terms

Conditions

Constipation

Interventions

polyethylene glycol 3350; Electrolytes; prucalopride

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

• Rodica Cinci, Prof Dr

  Pierrel Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 2, 2010
• Study Start: November 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 31, 2012

Record last verified: 2012-08

Locations

RO (1)