Effectiveness of Docusate in Preventing/Treating Constipation in Palliative Care Patients

Constipation Clinical Trial

Official title:

Randomized, Double-Blind, Placebo-Controlled Trial of Oral Docusate for Preventing/Treating Constipation in Palliative Care Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902031
• Other study ID #: G599001036
• Secondary ID: G517000014
• Status: Completed
• Phase: N/A
• First received: May 13, 2009
• Last updated: April 19, 2011
• Start date: April 2006
• Est. completion date: October 2010

Study information

• Verified date: April 2011
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if docusate is effective in the treatment of constipation in palliative care patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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%

Exclusion Criteria:

• 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%

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Constipation
• Palliative Care

Intervention

Drug:
• Docusate Sodium, Sennoside
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 + Placebo
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

Locations

Country	Name	City	State
Canada	CapitalCare Norwood	Edmonton	Alberta
Canada	Mel Miller Hospice at Edmonton General Continuing Care Hospital	Edmonton	Alberta
Canada	St. Joseph's Auxiliary Care Hospital	Edmonton	Alberta

Sponsors (4)

Lead Sponsor	Collaborator
University of Alberta	Capital Care, College of Family Physicians of Canada (Janus Research Grant), Covenant Health

Country where clinical trial is conducted

Canada, 

References & Publications (5)

CASS LJ, FREDERIK WS. Doxinate in the treatment of constipation. Am J Gastroenterol. 1956 Dec;26(6):691-8. — View Citation

Castle SC, Cantrell M, Israel DS, Samuelson MJ. Constipation prevention: empiric use of stool softeners questioned. Geriatrics. 1991 Nov;46(11):84-6. — View Citation

Fain 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. — View Citation

Goodman J, Pang J, Bessman AN. Dioctyl sodium sulfosuccinate- an ineffective prophylactic laxative. J Chronic Dis. 1976 Jan;29(1):59-63. — View Citation

Hurdon 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool Frequency		10 days	No
Primary	Stool Consistency		10 day	No
Primary	Difficulty Defecating		10 day	No
Primary	Symptoms Related to Constipation (pain, nausea, appetite loss, abdominal discomfort, shortness of breath)		10 day	No
Primary	Type of Additional Bowel Care Interventions which may be Required		10 days	No