Comparison of PEG Solutions With and Without Electrolytes in the Treatment of Constipation
PEGorion
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
1 other identifier
interventional
67
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2008
Shorter than P25 for phase_4
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 16, 2008
CompletedFirst Posted
Study publicly available on registry
January 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedOctober 7, 2008
October 1, 2008
6 months
January 16, 2008
October 6, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stool frequency
week 4
Secondary Outcomes (3)
Stool frequency
Week 2
Stool straining
Weeks 2 and 4
Stool consistency
Weeks 2 and 4
Study Arms (2)
T
EXPERIMENTALTest product
C
ACTIVE COMPARATORReference product
Interventions
powder for oral solution 12 g of PEG once a day, twice a day or once every other day for 4 weeks
granules for oral solution 12 g of PEG once a day, twice a day or once every other day for 4 weeks
Eligibility Criteria
You may qualify if:
- Isotonic PEG treatment for constipation at the stable dose for at least 2 weeks before the run-in period
You may not qualify if:
- Other medical treatment for constipation than isotonic PEG or plantago ovata seeds
- Severe dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Koskikoti
Tampere, 33100, Finland
Koivupirtti
Tampere, 33500, Finland
Tampereen sotainvalidien Veljeskoti
Tampere, 33500, Finland
Lahdensivun koti
Tampere, 33560, Finland
Nurmikoti
Tampere, 33680, Finland
Vire Koti Kaukaharju assisted-living facility
Tampere, 33710, Finland
Taatala assested-living facility
Tampere, 33820, Finland
Kuusela assisted-living facility
Tampere, 33900, Finland
Petäjäkoti
Tampere, 33900, Finland
Nursing home of Tiuravuori
Ylöjärvi, 33480, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lauri Seinelä, MD
Pirkanmaan erikoislääkäripalvelu Oy
- STUDY DIRECTOR
Ulla Sairanen, MSc
Orion Corporation, Orion Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 16, 2008
First Posted
January 29, 2008
Study Start
January 1, 2008
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
October 7, 2008
Record last verified: 2008-10