ConstipationNCT00902031
Effectiveness of Docusate in Preventing/Treating Constipation in Palliative Care Patients
A study testing Docusate Sodium, Sennoside in people with Constipation and Palliative Care, run by University of Alberta at 3 sites in Canada.
Trial summary
The purpose of this study is to determine if docusate is effective in the treatment of constipation in palliative care patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation, Palliative Care
- What is being tested?
- Docusate Sodium, Sennoside
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 3 sitesCanada
- Study dates
- Apr 2006to Oct 2010
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- greater than or equal to 18 years of age
- new admissions
- able to take oral medications
- patient and/or personal directive agent (proxy) provides written consent
- does not have a stoma
- no difficulty swallowing
- no previous intolerance/contraindications to docusate
- palliative performance greater than or equal to 20%
Who cannot join
- less than 18 years of age
- failing to provide consent
- unable to take oral medication/difficulty swallowing
- previous intolerance/contraindications to docusate (Colace)
- patients who have a stoma
- palliative performance status < 20%
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
CapitalCare Norwood
Edmonton, Alberta, T5G 3A2
Mel Miller Hospice at Edmonton General Continuing Care Hospital
Edmonton, Alberta, T5K 0A1
St. Joseph's Auxiliary Care Hospital
Edmonton, Alberta, T6J 6W1
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Trial of Oral Docusate for Preventing/Treating Constipation in Palliative Care Patients.
The purpose of this study is to determine if docusate is effective in the treatment of constipation in palliative care patients.
Read the detailed description
Palliative patients frequently experience constipation due to multiple factors - structural abnormalities, medications, metabolic disturbances, neurological disorders, and other general conditions. Docusate is a stool softener that has been widely used, in combination with other stimulating laxatives, to prevent and treat constipation in palliative care patients. In the past decade there has been controversy about its effectiveness in these populations, but no controlled trials have been conducted on the use of docusate in palliative patients. The purpose of this study is to assess the effectiveness of docusate in preventing and treating constipation in palliative care patients. The study design is a randomized, double-blind, placebo-controlled trial to compare the current standard treatment (docusate in combination with a laxative, sennoside) to that of a sennoside laxative alone. A total of 70 patients (35 in each group) will be recruited from the Palliative Care Unit at St. Joseph's Auxiliary Care Hospital, the Mel Miller Hospice at the Edmonton General Continuing Care Hospital, and CapitalCare Norwood in Edmonton, Alberta, Canada. Patients must be ≥ 18 years of age, able to take oral medication, without difficulty swallowing, have a palliative performance ≥ 20%, and do not have a stoma. The duration of treatment will be for 10 days. The main outcome measures will include bowel frequency, stool consistency, other interventions (suppositories, enemas), difficulty defecating, and sense of inability to evacuate completely. This study will provide insight into the effectiveness of docusate in preventing and treating constipation in palliative patients who are cared for by family physicians and specialized palliative care providers. If docusate is found to have no added benefit,it has the potential to enhance the quality of life for palliative care patients by reducing the number of medications taken and reducing the palliative care team's (e.g. nursing) workload and cost.
- Conditions
- Constipation, Palliative Care
- Being tested
- Docusate Sodium, Sennoside, Sennoside + Placebo
- Keywords
- Docusate, Constipation, Colace, Palliative Care, Sennoside, Senokot, Terminally Ill, Stool, Randomized Trial
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docusate Sodium, SennosideDrug
Also called Colace, Senokot
Docusate sodium: given in capsule form (100 mg/capsule), at a dosage of 200 mg, taken twice daily for 10 days.
Sennoside: will be given in tablet form (8.6 mg), 1-3 tablets taken 1-3 times daily for 10 days.
Sennoside + PlaceboDrug
Also called Senokot
Sennoside: will be given in tablet form (8.6 mg), 1-3 tablets taken 1-3 times daily for 10 days.
Placebo: will be taken in capsule form, similar in size, shape, and color to docusate, taken twice daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Docusate + Sennoside | Experimental | Not described Receives: Drug: Docusate Sodium, Sennoside |
| Sennoside + Placebo | Placebo comparator | Not described Receives: Drug: Sennoside + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool Frequency
Measured: 10 days
Stool Consistency
Measured: 10 day
Difficulty Defecating
Measured: 10 day
Symptoms Related to Constipation (pain, nausea, appetite loss, abdominal discomfort, shortness of breath)
Measured: 10 day
Type of Additional Bowel Care Interventions which may be Required
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startApr 2006
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- College of Family Physicians of Canada, Covenant Health, Canada, Capital Care
- Investigators
- Richard Spooner, MD, Principal investigator, University of AlbertaYoko Tarumi, MD, Principal investigator, University of Alberta/Regional Palliatvie Care Program (Capital Health)Olga Szafran, MSc., Study director, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902031
- Sponsor's protocol ID
- G599001036
- Other IDs
- G517000014
- Status last verified
- Apr 2011
- First submitted
- 13 May 2009
- Last updated
- 20 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
CASS LJ, FREDERIK WS. Doxinate in the treatment of constipation. Am J Gastroenterol. 1956 Dec;26(6):691-8. No abstract available.
PubMed 13372512Castle SC, Cantrell M, Israel DS, Samuelson MJ. Constipation prevention: empiric use of stool softeners questioned. Geriatrics. 1991 Nov;46(11):84-6. No abstract available.
PubMed 1718823Fain AM, Susat R, Herring M, Dorton K. Treatment of constipation in geriatric and chronically ill patients: a comparison. South Med J. 1978 Jun;71(6):677-80. doi: 10.1097/00007611-197806000-00022.
PubMed 78527Goodman J, Pang J, Bessman AN. Dioctyl sodium sulfosuccinate- an ineffective prophylactic laxative. J Chronic Dis. 1976 Jan;29(1):59-63. doi: 10.1016/0021-9681(76)90068-0. No abstract available.
PubMed 1254685Hurdon V, Viola R, Schroder C. How useful is docusate in patients at risk for constipation? A systematic review of the evidence in the chronically ill. J Pain Symptom Manage. 2000 Feb;19(2):130-6. doi: 10.1016/s0885-3924(99)00157-8.
PubMed 10699540
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Trial of Oral Docusate for Preventing/Treating Constipation in Palliative Care Patients.
- ClinicalTrials.gov ID
- NCT00902031
- Acronym / sponsor ID
- G599001036
- Conditions
- Constipation, Palliative Care
- Keywords
- Docusate, Constipation, Colace, Palliative Care, Sennoside, Senokot, Terminally Ill, Stool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- College of Family Physicians of Canada, Covenant Health, Canada, Capital Care
- Study start
- Apr 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 14 May 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 determine if docusate is effective in the treatment of constipation in palliative care patients.
Detailed description
Palliative patients frequently experience constipation due to multiple factors - structural abnormalities, medications, metabolic disturbances, neurological disorders, and other general conditions. Docusate is a stool softener that has been widely used, in combination with other stimulating laxatives, to prevent and treat constipation in palliative care patients. In the past decade there has been controversy about its effectiveness in these populations, but no controlled trials have been conducted on the use of docusate in palliative patients. The purpose of this study is to assess the effectiveness of docusate in preventing and treating constipation in palliative care patients. The study design is a randomized, double-blind, placebo-controlled trial to compare the current standard treatment (docusate in combination with a laxative, sennoside) to that of a sennoside laxative alone. A total of 70 patients (35 in each group) will be recruited from the Palliative Care Unit at St. Joseph's Auxiliary Care Hospital, the Mel Miller Hospice at the Edmonton General Continuing Care Hospital, and CapitalCare Norwood in Edmonton, Alberta, Canada. Patients must be ≥ 18 years of age, able to take oral medication, without difficulty swallowing, have a palliative performance ≥ 20%, and do not have a stoma. The duration of treatment will be for 10 days. The main outcome measures will include bowel frequency, stool consistency, other interventions (suppositories, enemas), difficulty defecating, and sense of inability to evacuate completely. This study will provide insight into the effectiveness of docusate in preventing and treating constipation in palliative patients who are cared for by family physicians and specialized palliative care providers. If docusate is found to have no added benefit,it has the potential to enhance the quality of life for palliative care patients by reducing the number of medications taken and reducing the palliative care team's (e.g. nursing) workload and cost.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docusate + Sennoside | Experimental | Drug: Docusate Sodium, Sennoside |
| Sennoside + Placebo | Placebo comparator | Drug: Sennoside + Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- greater than or equal to 18 years of age
- new admissions
- able to take oral medications
- patient and/or personal directive agent (proxy) provides written consent
- does not have a stoma
Key exclusion criteria (6 listed)
- less than 18 years of age
- failing to provide consent
- unable to take oral medication/difficulty swallowing
- previous intolerance/contraindications to docusate (Colace)
- patients who have a stoma
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 |
|---|---|---|
| Docusate Sodium, SennosideAlso: Colace, SenokotDocusate sodium: given in capsule form (100 mg/capsule), at a dosage of 200 mg, taken twice daily for 10 days. Sennoside: will be given in tablet form (8.6 mg), 1-3 tablets taken 1-3 times daily for 10 days. | Drug | Docusate + Sennoside |
| Sennoside + PlaceboAlso: SenokotSennoside: will be given in tablet form (8.6 mg), 1-3 tablets taken 1-3 times daily for 10 days. Placebo: will be taken in capsule form, similar in size, shape, and color to docusate, taken twice daily for 10 days | Drug | Sennoside + Placebo |
Primary outcome
Stool Frequency
Time frame: 10 days
Stool Consistency
Time frame: 10 day
Difficulty Defecating
Time frame: 10 day
Symptoms Related to Constipation (pain, nausea, appetite loss, abdominal discomfort, shortness of breath)
Time frame: 10 day
Type of Additional Bowel Care Interventions which may be Required
Time frame: 10 days
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 Apr 2011.
- Background: PubMed 13372512CASS LJ, FREDERIK WS. Doxinate in the treatment of constipation. Am J Gastroenterol. 1956 Dec;26(6):691-8. No abstract available.
- Background: PubMed 1718823Castle SC, Cantrell M, Israel DS, Samuelson MJ. Constipation prevention: empiric use of stool softeners questioned. Geriatrics. 1991 Nov;46(11):84-6. No abstract available.
- Background: PubMed 78527Fain AM, Susat R, Herring M, Dorton K. Treatment of constipation in geriatric and chronically ill patients: a comparison. South Med J. 1978 Jun;71(6):677-80. doi: 10.1097/00007611-197806000-00022.
- Background: PubMed 1254685Goodman J, Pang J, Bessman AN. Dioctyl sodium sulfosuccinate- an ineffective prophylactic laxative. J Chronic Dis. 1976 Jan;29(1):59-63. doi: 10.1016/0021-9681(76)90068-0. No abstract available.
- Background: PubMed 10699540Hurdon V, Viola R, Schroder C. How useful is docusate in patients at risk for constipation? A systematic review of the evidence in the chronically ill. J Pain Symptom Manage. 2000 Feb;19(2):130-6. doi: 10.1016/s0885-3924(99)00157-8.
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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.
Richard Spooner, MD principal investigator
University of Alberta
Yoko Tarumi, MD principal investigator
University of Alberta/Regional Palliatvie Care Program (Capital Health)
Olga Szafran, MSc. study director
University of Alberta
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Docusate Sodium, Sennoside in people with Constipation and Palliative Care, run by University of Alberta at 3 sites in Canada.
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 8 inclusion and 6 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 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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. Some participants in this study may receive a placebo. 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?
Stool Frequency (time frame: 10 days). The study lists 5 primary outcomes in all. 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 NCT00902031, which also lists 5 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 Apr 2011.