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

This study has been completed.
Sponsor:
Collaborators:
College of Family Physicians of Canada (Janus Research Grant)
Covenant Health
Capital Care
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00902031
First received: May 13, 2009
Last updated: April 19, 2011
Last verified: April 2011

May 13, 2009
April 19, 2011
April 2006
October 2010   (final data collection date for primary outcome measure)
  • Stool Frequency [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Stool Consistency [ Time Frame: 10 day ] [ Designated as safety issue: No ]
  • Difficulty Defecating [ Time Frame: 10 day ] [ Designated as safety issue: No ]
  • Symptoms Related to Constipation (pain, nausea, appetite loss, abdominal discomfort, shortness of breath) [ Time Frame: 10 day ] [ Designated as safety issue: No ]
  • Type of Additional Bowel Care Interventions which may be Required [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00902031 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effectiveness of Docusate in Preventing/Treating Constipation in Palliative Care Patients
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Constipation
  • Palliative Care
  • 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.

    Other Names:
    • Colace
    • Senokot
  • Drug: 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

    Other Name: Senokot
  • Experimental: Docusate + Sennoside
    Intervention: Drug: Docusate Sodium, Sennoside
  • Placebo Comparator: Sennoside + Placebo
    Intervention: Drug: Sennoside + Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
October 2010
October 2010   (final data collection date for primary outcome measure)

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%
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00902031
G599001036, G517000014
No
Dr. Richard Spooner, University of Alberta
University of Alberta
  • College of Family Physicians of Canada (Janus Research Grant)
  • Covenant Health
  • Capital Care
Principal Investigator: Richard Spooner, MD University of Alberta
Principal Investigator: Yoko Tarumi, MD University of Alberta/Regional Palliatvie Care Program (Capital Health)
Study Director: Olga Szafran, MSc. University of Alberta
University of Alberta
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP