Opioid-induced ConstipationNCT01645371
Assessing a Stool Symptom Screener in Patients With Chronic Opioid-Induced Constipation
An observational study of Opioid-induced Constipation, run by AstraZeneca.
Trial summary
This qualitative research is to assess the validity of the stool symptom screener that will be used in patients with chronic opioid-induced constipation to determine the adequacy of their response to laxatives. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Opioid-induced Constipation
- How many people
- 79 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Feb 2013
- 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 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: multi-speciality medical clinics ( family practice, neurology, internal medicine, pain management)
Who may be able to join
- Receiving a stable maintenance opioid regimen (total daily dose of 30-1000mg of oral morphine, or equianalgesic amounts of 1 or more other opioid therapies) for a minimum of 4 weeks for non-cancer related pain.
- Development of constipation symptoms since starting opioids.
- Taken laxatives to help with bowel movements for at least four days over the past 2 weeks.
Who cannot join
- Receiving opioid regimen for treatment of pain related to cancer.
- Participated in any clinical trial or research study relating to opioid use and/or constipation within the past year.
- History of cancer within 5 years from the time of screening.
- Has medical condition(s) and/or treatment(s) associated with diarrhea, intermittent loose stools, or constipation (e.g., fecal incontinence or chronic idiopathic constipation).
- Has irritable bowel syndrome (IBS) or chronic functional constipation.
About this study
Official title: Assessing the Content Validity of a Stool Symptom Screener in Patients With Chronic Opioid-Induced Constipation
This qualitative research is to assess the validity of the stool symptom screener that will be used in patients with chronic opioid-induced constipation to determine the adequacy of their response to laxatives.
Read the detailed description
Assessing the Content Validity of a Stool Symptom Screener in Patients with Chronic Opioid-Induced Constipation
- Conditions
- Opioid-induced Constipation
- Keywords
- opioid-induced constipation
- Medical subject headings
- Opioid-Induced Constipation
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 |
|---|---|---|
| Subjects with opioid induced constipation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-structured discussion guide
Using a semi-structured discussion guide during a single one-on-one interview, qualitative information will be collected from subjects that relates to their experience with Opioid Induced Constipation symptoms and to their understanding and perception of a verbally-administered stool symptom screener.
Measured: Data will be collected at ONE time point from each patient using a semi-structured interview guide (up to 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid-induced ConstipationStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Sostek, MD, Study director, AstraZenecaKarin S Coyne, PHD, MPH, Principal investigator, United BioSource
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645371
- Sponsor's protocol ID
- D3820C00028
- Status last verified
- Oct 2014
- First submitted
- 12 Jul 2012
- Last updated
- 20 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Frank L, Kleinman L, Farup C, Taylor L, Miner P Jr. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol. 1999 Sep;34(9):870-7. doi: 10.1080/003655299750025327.
PubMed 10522604Slappendel R, Simpson K, Dubois D, Keininger DL. Validation of the PAC-SYM questionnaire for opioid-induced constipation in patients with chronic low back pain. Eur J Pain. 2006 Apr;10(3):209-17. doi: 10.1016/j.ejpain.2005.03.008.
PubMed 15914049
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Content Validity of a Stool Symptom Screener in Patients With Chronic Opioid-Induced Constipation
- ClinicalTrials.gov ID
- NCT01645371
- Acronym / sponsor ID
- D3820C00028
- Conditions
- Opioid-induced Constipation
- Keywords
- opioid-induced constipation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 20 Jul 2012 (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 qualitative research is to assess the validity of the stool symptom screener that will be used in patients with chronic opioid-induced constipation to determine the adequacy of their response to laxatives.
Detailed description
Assessing the Content Validity of a Stool Symptom Screener in Patients with Chronic Opioid-Induced Constipation
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with opioid induced constipation | – | – |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- multi-speciality medical clinics ( family practice, neurology, internal medicine, pain management)
Key inclusion criteria (3 listed)
- Receiving a stable maintenance opioid regimen (total daily dose of 30-1000mg of oral morphine, or equianalgesic amounts of 1 or more other opioid therapies) for a minimum of 4 weeks for non-cancer related pain.
- Development of constipation symptoms since starting opioids.
- Taken laxatives to help with bowel movements for at least four days over the past 2 weeks.
Key exclusion criteria (5 listed)
- Receiving opioid regimen for treatment of pain related to cancer.
- Participated in any clinical trial or research study relating to opioid use and/or constipation within the past year.
- History of cancer within 5 years from the time of screening.
- Has medical condition(s) and/or treatment(s) associated with diarrhea, intermittent loose stools, or constipation (e.g., fecal incontinence or chronic idiopathic constipation).
- Has irritable bowel syndrome (IBS) or chronic functional constipation.
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
Semi-structured discussion guide
Time frame: Data will be collected at ONE time point from each patient using a semi-structured interview guide (up to 5 months)
Using a semi-structured discussion guide during a single one-on-one interview, qualitative information will be collected from subjects that relates to their experience with Opioid Induced Constipation symptoms and to their understanding and perception of a verbally-administered stool symptom screener.
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 20 Oct 2014.
- Background: PubMed 10522604Frank L, Kleinman L, Farup C, Taylor L, Miner P Jr. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol. 1999 Sep;34(9):870-7. doi: 10.1080/003655299750025327.
- Background: PubMed 15914049Slappendel R, Simpson K, Dubois D, Keininger DL. Validation of the PAC-SYM questionnaire for opioid-induced constipation in patients with chronic low back pain. Eur J Pain. 2006 Apr;10(3):209-17. doi: 10.1016/j.ejpain.2005.03.008.
- D3820C00028\_statement\_of\_no\_CSR\_Synopsis.pdfLink provided by the sponsor.
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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.
Mark Sostek, MD study director
AstraZeneca
Karin S Coyne, PHD, MPH principal investigator
United BioSource
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-induced Constipation, run by AstraZeneca.
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 5 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 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Semi-structured discussion guide (time frame: Data will be collected at ONE time point from each patient using a semi-structured interview guide (up to 5 months)). 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 NCT01645371, which also lists 2 linked publications.
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 20 Oct 2014.