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Phase I Double-Blind, Placebo-Controlled Trial of 27 mg Dolcanatide (SP-333) to Demonstrate Colorectal Bioactivity in Healthy Volunteers

Enrollment Statistics

Expected Enrollment: 40

Actual Enrollment: 37

  • 27 participants randomized
    • 10 not randomized (ineligible, comorbidity or concomitant medications)
  • 25 completed intervention (25 of 37)
  • 24 completed post-intervention tests (24 of 37)

Total Study Population Demographics (27 Randomized and Eligible People):

  • Age (years):
    • Mean: 47.2
    • Range: 45.8-57.9
    • Median: 50.4
  • Height (cm):
    • Mean: 171
    • IQR: 164 - 180
    • Range: 158 - 183
    • Median: 172
  • Weight (kg):
    • Mean: 84
    • IQR: 74 - 90
    • Range: 38 - 112
    • Median: 82
  • Sex
    • Females: 4 (14.8%)
    • Males: 23 (85.2%)

Final Analysis Population: 24