ConstipationPhase 3NCT01251822
Comparator Study of PEG 3350 Versus Prucalopride in Females With Chronic Constipation
A Phase 3 study testing PEG 3350 plus electrolytes and Prucalopride in people with Constipation, run by Norgine at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Constipation
- What is being tested?
- PEG 3350 plus electrolytes and Prucalopride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteRomania
- Study dates
- Nov 2010to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- PEG 3350 plus electrolytes, Prucalopride
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG 3350 plus electrolytesDrug
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.
PrucaloprideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| PEG 3350 | Experimental | PEG 3350 plus electrolytes in solution plus placebo tablets Receives: Drug: PEG 3350 plus electrolytes |
| Prucalopride | Active comparator | Prucalopride tablets plus placebo solution Receives: Drug: Prucalopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of spontaneous bowel movements
Proportion of patients having normal number of spontaneous bowel movements during the last treatment week.
Measured: Days 22 to 28 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rodica Cinci, Prof Dr, Principal investigator, Pierrel Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251822
- Sponsor's protocol ID
- PEG-01/2010 (PRUC)
- Status last verified
- Aug 2012
- First submitted
- 30 Nov 2010
- Last updated
- 31 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23480216
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01251822
- Acronym / sponsor ID
- PEG-01/2010 (PRUC)
- Conditions
- Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG 3350 | Experimental | Drug: PEG 3350 plus electrolytesPEG 3350 plus electrolytes in solution plus placebo tablets |
| Prucalopride | Active comparator | Drug: PrucalopridePrucalopride tablets plus placebo solution |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG 3350 plus electrolytesEach 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. | Drug | PEG 3350 |
| PrucalopridePatients 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. | Drug | Prucalopride |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2012.
- Derived from this study: PubMed 23480216Cinca 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodica Cinci, Prof Dr principal investigator
Pierrel Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PEG 3350 plus electrolytes and Prucalopride in people with Constipation, run by Norgine at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of spontaneous bowel movements (time frame: Days 22 to 28 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01251822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2012.