Constipation Clinical Trial
— PEGorionOfficial 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
Verified date | October 2008 |
Source | Orion Corporation, Orion Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Finnish Medicines Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 67 |
Est. completion date | July 2008 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - Isotonic PEG treatment for constipation at the stable dose for at least 2 weeks before the run-in period Exclusion Criteria: - Other medical treatment for constipation than isotonic PEG or plantago ovata seeds - Severe dementia |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Finland | Koivupirtti | Tampere | |
Finland | Koskikoti | Tampere | |
Finland | Kuusela assisted-living facility | Tampere | |
Finland | Lahdensivun koti | Tampere | |
Finland | Nurmikoti | Tampere | |
Finland | Petäjäkoti | Tampere | |
Finland | Taatala assested-living facility | Tampere | |
Finland | Tampereen sotainvalidien Veljeskoti | Tampere | |
Finland | Vire Koti Kaukaharju assisted-living facility | Tampere | |
Finland | Nursing home of Tiuravuori | Ylöjärvi |
Lead Sponsor | Collaborator |
---|---|
Orion Corporation, Orion Pharma |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stool frequency | week 4 | No | |
Secondary | Stool frequency | Week 2 | No | |
Secondary | Stool straining | Weeks 2 and 4 | No | |
Secondary | Stool consistency | Weeks 2 and 4 | No |
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