Effects of ROSE-010 on GI Transit in Constipation Predominant Irritable Bowel Syndrome (C-IBS) Pa… (NCT01056107) | Clinical Trial Compass
CompletedPhase 1/2
Effects of ROSE-010 on GI Transit in Constipation Predominant Irritable Bowel Syndrome (C-IBS) Patients
United States52 participantsStarted 2010-01
Plain-language summary
This trial will study the effects of an investigational (not FDA approved) medication, ROSE-010, on the movement of food through the stomach, small intestine and colon in females with constipation predominant irritable bowel syndrome (C-IBS).
The study hypothesis is that ROSE-010 will delay gastric emptying of solids and enhances gastric accommodation without retarding colonic transit in female patients with C-IBS.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. Female aged 18-65 years old inclusive.
✓. A previous diagnosis of IBS according to Rome III criteria to include those patients who have had recurrent abdominal pain or discomfort for the at least the six months prior to diagnosis and currently at least three days per month in the last three months associated with two or more of the following:
✓. improvement with defecation
✓. onset associated with a change in the frequency of stool
✓. onset associated with a change in form (appearance) of stool.
✓. Constipation predominant type IBS as defined by one or more of the following:
✓. fewer than three spontaneous complete bowel movements per week
✓. hard or lumpy stools more than 25% of the time
Exclusion criteria
✕. Female patients who are pregnant or breast-feeding.
✕. Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders other than C-IBS.
✕. Unable to withdraw medications 48 hours prior to the study: any medication that alters GI transit including but not limited to laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants and serotonin-norepinephrine reuptake inhibitors (SNRIs); analgesic drugs including opiates, nonsteroidal anti-inflammatory drugs (NSAIDs), and COX 2 inhibitors (Note: Tylenol is permitted), GABAergic agents and benzodiazepines. Note: All other concomitant medications will be reviewed on a case by case basis by the study physicians.
What they're measuring
1
Colonic Transit, Colonic Geometric Center at 24 Hours
Timeframe: 24 hours (Visit 3 = Day 1)
2
Change Between Postprandial and Fasting Whole Gastric Volume by Technetium-99m (99mTc)-SPECT Imaging (Gastric Accommodation)
Timeframe: approximately 1 hour after 99mTC injection, approximately 30 min after liquid meal (Visit 5 = approximately 2-10 days after Visit 4)
3
Half Time (t1/2) of Gastric Emptying of Solids Measured by Scintigraphy (Gastric Transit)
Timeframe: approximately 2 hours after radiolabeled meal is ingested (Visit 2 = Day 0)
✕. Clinical evidence (including but not limited to a clinically significant abnormal physical exam, ECG or laboratory result in the past medical record) or current clinically significant abnormal physical exam or laboratory test result that could indicate significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other diseases that interfere with the objectives of the study. If a laboratory test result is abnormal and clinically significant, it may be repeated once at the discretion of the PI. If the laboratory test result remains abnormal and clinically significant, the patient will be referred to a primary care physician for further evaluation.
✕. Patients who are considered by the Investigator to be alcoholics not in remission or known substance abusers.
✕. Patients who have participated in another clinical study within the past 30 days.