NCT00902031 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

CASS LJ, FREDERIK WS
Doxinate in the treatment of constipation. Am J Gastroenterol. 1956 Dec;26(6):691-8.
Castle SC, Cantrell M, Israel DS, Samuelson MJ
Constipation prevention: empiric use of stool softeners questioned. Geriatrics. 1991 Nov;46(11):84-6.
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.
Goodman J, Pang J, Bessman AN
Dioctyl sodium sulfosuccinate- an ineffective prophylactic laxative. J Chronic Dis. 1976 Jan;29(1):59-63.
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.

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

Clinical trial NCT00902031 - References