Trial Outcomes & Findings for Effects of ROSE-010 on GI Transit in Constipation Predominant Irritable Bowel Syndrome (C-IBS) Patients (NCT NCT01056107)

Subjects were recruited at the Mayo Clinic in Rochester, Minnesota.

52 subjects were enrolled, but 6 subjects were excluded because they did not meet eligibility criteria.

Effects of ROSE-010 on GI Transit in Constipation Predominant Irritable Bowel Syndrome (C-IBS) Patients

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. 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.

A noninvasive SPECT method was used to measure gastric volume during fasting and 32 min after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC was giving by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication was given s.c. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans were obtained. Each scan required 9-12 min. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. For this outcome measure, the scans for the "fasting volume" and 2 "postprandial volumes" were used. The 2 postprandial (PP) volumes were averaged. Change was calculated as (PP - Fasting = gastric accommodation).

Half time (t1/2) of gastric emptying (GE) of solids is the time for half of the ingested solids or liquids to leave the stomach. The scintigraphy for GE t1/2 was done on Visit 2 (Day 0 of the study), the first day of scintigraphy.

The gastric residual will be calculated as the proportion of isotope remaining in the stomach (at 2 and 4 hours).

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. 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. (Note: when there is no radio isotope in the colon (e.g., at 4 hours) the geometric center values are recorded as "zero," thus the mean values can be less than one.)

Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.

Ascending colon emptying half-time will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 48 hour data.

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. 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.

Stool frequency was self reported in a Bowel Pattern Diary. The bowel pattern diary was dispensed at the screening visit, and the completed bowel pattern diary was collected at the completion of the study.

The subjects rated their stool consistency using the 7-point Bristol Stool Scale. 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. The Bristol stool form was part of the bowel pattern diary, which was dispensed at the screening visit, and the completed bowel pattern diary was collected at the completion of the study.