| Outcome Measures: |
Primary: Colonic Geometric Center at 24 Hours (GC24) Measured by Scintigraphy, The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images of the abdomen are taken hourly for the first 6 hours after the radio-labeled meal, then at 8, 24 and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. GC24 is the measurement taken at 24 hours after the radio-labeled meal., Baseline period (days 7-9 ), Treatment period (days 14-17)|Ascending Colon Emptying Half-time (AC t1/2) Measured in Hours, Calculated by linear interpolation of values on the AC emptying curve., Baseline period (days 7-9 ), Treatment period (days 14-17) | Secondary: Gastric Emptying Half-time (GE t1/2), The measure of time for 50 percent of a radio-labeled meal to empty from the stomach., Baseline period (9 days), Treatment period (7 days)|Colonic Filling at 6 Hours, The proportion of a radio-labeled meal in the colon at 6 hours (identifiable by radio-labelled tracer to capsule eaten with meal), measured by scintigraphy. This is an indirect measurement of small-bowel transit time., Baseline period (9 days), Treatment period (7 days)|Colonic Geometric Center at 48 Hours (GC48) as Measured by Scintigraphy, The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly for the first 6 hours after the radio-labeled meal, then at 8, 24 and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. GC48 is the measurement taken at 48 hours after the radio-labeled meal., Baseline period (days 7-9 ), Treatment period (days 14-17)|Stool Frequency Per Day, During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record the number of times per day they had a bowel movement. Only the 7 days of highest treatment dose will be used for comparison purposes., Daily during baseline period (9 days), Treatment period (7 days)|Stool Form/Consistency, During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record a description of stool consistency according to the Bristol Stool Form Scale (ranging from 1 (hard lumps) to 7 (watery)). The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the "ideal stools" especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea., Daily during baseline period (9 days), Treatment period (7 days)|Stool Ease of Passage, During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record a description of stool ease of passage of stool, according to the Bristol Stool Form Scale (ranging from 1 (manual disimpaction) to 7 (incontinence)). Only the 7 days at highest treatment dose will be used for comparison purposes., Daily during baseline period (9 days), Treatment period (7 days)|Sense of Completely Emptying Bowels, During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record whether or not they felt they had completely emptied their bowels(1= Yes; 0= No). Only the 7 days of highest treatment dose will be used for comparison purposes., Daily during baseline period (9 days), Treatment period (7 days)|Stool Frequency Per Week, During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record the number of times per day they had a bowel movement. Complete spontaneous bowel movements per week are reported. Only the 7 days of highest treatment dose will be used for comparison purposes., Daily during baseline period (9 days), Treatment period (7 days)|Heart Rate Before and After Treatment, Heart rate is the number of beats per minute, as recording on an Electrocardiogram (ECG)., Baseline period (9 days), Treatment period (7 days)|QTc Interval Before and After Treatment, The corrected QT interval (QTc) is a measurement of time (seconds) between the Q and T waves of an heart beat as recorded during an Electrocardiogram (ECG)., Baseline period (9 days), Treatment period (7 days)
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