ConstipationPhase 4PEGorionNCT00603681
Comparison of PEG Solutions With and Without Electrolytes in the Treatment of Constipation
A Phase 4 study testing Polyethylene glycol 4000 and Polyethylene glycol 4000 with electrolytes in people with Constipation, run by Orion Corporation, Orion Pharma at 10 sites in Finland.
Trial summary
The aim of the study is to show that new polyethylene glycol (PEG) solution without electrolytes is as effective in the treatment of constipation as PEG solution with electrolytes in the elderly institutionalized people. Also, the tolerability and the safety of the study drug will be examined. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- Polyethylene glycol 4000 and Polyethylene glycol 4000 with electrolytes
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 10 sitesFinland
- Study dates
- Jan 2008to Jul 2008
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Isotonic PEG treatment for constipation at the stable dose for at least 2 weeks before the run-in period
Who cannot join
- Other medical treatment for constipation than isotonic PEG or plantago ovata seeds
- Severe dementia
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Finland10 sites
Koskikoti
Tampere, 33100
Koivupirtti
Tampere, 33500
Tampereen sotainvalidien Veljeskoti
Tampere, 33500
Lahdensivun koti
Tampere, 33560
Nurmikoti
Tampere, 33680
Vire Koti Kaukaharju assisted-living facility
Tampere, 33710
Taatala assested-living facility
Tampere, 33820
Kuusela assisted-living facility
Tampere, 33900
Petäjäkoti
Tampere, 33900
Nursing home of Tiuravuori
Ylöjärvi, 33480
About this study
Official title: Non-Inferiority Study; Comparison of Polyethylene Glycol Solution With and Without Electrolytes for Treatment of Chronic Constipation in Elderly Institutionalised Patients: a Double-Blind, Randomised, Parallel-Group, Multicentre Study
The aim of the study is to show that new polyethylene glycol (PEG) solution without electrolytes is as effective in the treatment of constipation as PEG solution with electrolytes in the elderly institutionalized people. Also, the tolerability and the safety of the study drug will be examined.
Read the detailed description
Constipation is a major problem in elderly institutionalised patients. Non-pharmacological treatments are proposed as primary management of constipation, but institutionalised patients are not likely to be able to increase either the intake of dietary fibre or fluid and their physical activity is low.
The latest agent widely used for the treatment of constipation is polyethylene glycol (PEG). PEG is classified into the group of osmotic laxatives. It is minimally absorbed from the gastrointestinal tract and not metabolised by colonic bacteria.
Most of the PEG products at the market contain electrolytes and have a salty and unpleasant taste which may affect the compliance of using them. A PEG solution without electrolytes has been developed and used for some years in various countries. Now we will compare the efficacy and safety of PEG solutions with or without electrolytes and their acceptability in the use for constipation in institutionalised patients.
- Conditions
- Constipation
- Being tested
- Polyethylene glycol 4000, Polyethylene glycol 4000 with electrolytes
- Keywords
- constipation, aged, polyethylene glycol
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene glycol 4000Drug
Also called Pegorion
powder for oral solution 12 g of PEG once a day, twice a day or once every other day for 4 weeks
Polyethylene glycol 4000 with electrolytesDrug
Also called Colonsoft
granules for oral solution 12 g of PEG once a day, twice a day or once every other day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| T | Experimental | Test product Receives: Drug: Polyethylene glycol 4000 |
| C | Active comparator | Reference product Receives: Drug: Polyethylene glycol 4000 with electrolytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool frequency
Measured: week 4
Secondary outcomes (3)
Stool frequency
Measured: Week 2
Stool straining
Measured: Weeks 2 and 4
Stool consistency
Measured: Weeks 2 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lauri Seinelä, MD, Principal investigator, Pirkanmaan erikoislääkäripalvelu OyUlla Sairanen, MSc, Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603681
- Sponsor's protocol ID
- 3066001
- Acronym
- PEGorion
- Status last verified
- Oct 2008
- First submitted
- 16 Jan 2008
- Last updated
- 7 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Inferiority Study; Comparison of Polyethylene Glycol Solution With and Without Electrolytes for Treatment of Chronic Constipation in Elderly Institutionalised Patients: a Double-Blind, Randomised, Parallel-Group, Multicentre Study
- ClinicalTrials.gov ID
- NCT00603681
- Acronym / sponsor ID
- PEGorion / 3066001
- Conditions
- Constipation
- Keywords
- constipation, aged, polyethylene glycol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 29 Jan 2008 (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.
The aim of the study is to show that new polyethylene glycol (PEG) solution without electrolytes is as effective in the treatment of constipation as PEG solution with electrolytes in the elderly institutionalized people. Also, the tolerability and the safety of the study drug will be examined.
Detailed description
Constipation is a major problem in elderly institutionalised patients. Non-pharmacological treatments are proposed as primary management of constipation, but institutionalised patients are not likely to be able to increase either the intake of dietary fibre or fluid and their physical activity is low.
The latest agent widely used for the treatment of constipation is polyethylene glycol (PEG). PEG is classified into the group of osmotic laxatives. It is minimally absorbed from the gastrointestinal tract and not metabolised by colonic bacteria.
Most of the PEG products at the market contain electrolytes and have a salty and unpleasant taste which may affect the compliance of using them. A PEG solution without electrolytes has been developed and used for some years in various countries. Now we will compare the efficacy and safety of PEG solutions with or without electrolytes and their acceptability in the use for constipation in institutionalised patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T | Experimental | Drug: Polyethylene glycol 4000Test product |
| C | Active comparator | Drug: Polyethylene glycol 4000 with electrolytesReference product |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Isotonic PEG treatment for constipation at the stable dose for at least 2 weeks before the run-in period
Key exclusion criteria (2 listed)
- Other medical treatment for constipation than isotonic PEG or plantago ovata seeds
- Severe dementia
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 |
|---|---|---|
| Polyethylene glycol 4000Also: Pegorionpowder for oral solution 12 g of PEG once a day, twice a day or once every other day for 4 weeks | Drug | T |
| Polyethylene glycol 4000 with electrolytesAlso: Colonsoftgranules for oral solution 12 g of PEG once a day, twice a day or once every other day for 4 weeks | Drug | C |
Primary outcome
Stool frequency
Time frame: week 4
3 secondary outcomes
Stool frequency
Time frame: Week 2
Stool straining
Time frame: Weeks 2 and 4
Stool consistency
Time frame: Weeks 2 and 4
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 7 Oct 2008.
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This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
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Not yet recruiting
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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.
Lauri Seinelä, MD principal investigator
Pirkanmaan erikoislääkäripalvelu Oy
Ulla Sairanen, MSc study director
Orion Corporation, Orion Pharma
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polyethylene glycol 4000 and Polyethylene glycol 4000 with electrolytes in people with Constipation, run by Orion Corporation, Orion Pharma at 10 sites in Finland.
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 1 inclusion and 2 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 7 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Finland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Stool frequency (time frame: week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2008; AzTrials last refreshed its copy on 6 Nov 2026.