ConstipationNCT00849628
Use of Drugs and Constipation in Nursing Homes
An observational study of Constipation and Diarrhea, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is to study factors (drugs, serum concentration of drugs, nutrition, physical activity, demographics, diseases etc.) related to constipation and diarrhea in nursing homes, and the effect of different laxative regimens. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Constipation, Diarrhea
- How many people
- 267 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2008to Feb 2010
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Residents in nursing homes
Who may be able to join
- Above 60 years old
- Stayed in nursing homes for more than 8 weeks
- Informed consent
Who cannot join
- Expected discharge within 2 weeks
- Organic disorders causing constipation and diarrhea
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to study factors (drugs, serum concentration of drugs, nutrition, physical activity, demographics, diseases etc.) related to constipation and diarrhea in nursing homes, and the effect of different laxative regimens.
- Conditions
- Constipation, Diarrhea
- Keywords
- Aged, Polypharmacy, Adverse effects, Nursing homes
- Medical subject headings
- Constipation, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Constipation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of constipation
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startJun 2008
- Primary completionDec 2009
- Study completionFeb 2010
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.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Sykehuset Innlandet HF
- Responsible party
- Sponsor
- Investigators
- Per G Farup, PhD, Principal investigator, Sykehuset Innlandet HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849628
- Sponsor's protocol ID
- SI 150069-1
- Status last verified
- Jul 2016
- First submitted
- 23 Feb 2009
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Fosnes GS, Lydersen S, Farup PG. Drugs and constipation in elderly in nursing homes: what is the relation? Gastroenterol Res Pract. 2012;2012:290231. doi: 10.1155/2012/290231. Epub 2012 Feb 29.
PubMed 22505881
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Drugs and Constipation in Nursing Homes
- ClinicalTrials.gov ID
- NCT00849628
- Acronym / sponsor ID
- SI 150069-1
- Conditions
- Constipation, Diarrhea
- Keywords
- Aged, Polypharmacy, Adverse effects, Nursing homes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Sykehuset Innlandet HF
- Study start
- Jun 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 24 Feb 2009 (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 purpose of this study is to study factors (drugs, serum concentration of drugs, nutrition, physical activity, demographics, diseases etc.) related to constipation and diarrhea in nursing homes, and the effect of different laxative regimens.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Constipation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Residents in nursing homes
Key inclusion criteria (3 listed)
- Above 60 years old
- Stayed in nursing homes for more than 8 weeks
- Informed consent
Key exclusion criteria (2 listed)
- Expected discharge within 2 weeks
- Organic disorders causing constipation and diarrhea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of constipation
Time frame: One year
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 19 Jul 2016.
- Results publication: PubMed 22505881Fosnes GS, Lydersen S, Farup PG. Drugs and constipation in elderly in nursing homes: what is the relation? Gastroenterol Res Pract. 2012;2012:290231. doi: 10.1155/2012/290231. Epub 2012 Feb 29.
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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.
Per G Farup, PhD principal investigator
Sykehuset Innlandet HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation and Diarrhea, run by Norwegian University of Science and Technology at 1 site in Norway.
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 3 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 19 Jul 2016. 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 Norway. 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.
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?
Prevalence of constipation (time frame: One year). 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 NCT00849628, 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 19 Jul 2016.