Primary outcomeMean· 24 hours (Visit 3 = Day 1)
Colonic Transit, Colonic Geometric Center at 24 Hours
| Group | Value (units on a scale) | Spread |
|---|---|---|
| ROSE-010 30 Mcg | 2.39 | 0.22 |
| ROSE-010 100 Mcg | 2.37 | 0.41 |
| ROSE-010 300 Mcg | 2.02 | 0.23 |
| Placebo | 1.76 | 0.14 |
Trial · Interventional
CompletedPhase 1/2Results postedRegistry dataEffects of ROSE-010 on GI Transit in Constipation Predominant Irritable Bowel Syndrome (C-IBS) Patients
Overview
- Status
- Completed
- Phase
- Phase 1/2
- Enrollment
- 52 participants (actual)
- Sponsor
- Mayo Clinic · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- Jan 2010
- Primary completion
- Dec 2011
- Completion
- Dec 2011
- First posted
- 26 Jan 2010 (estimated)
- Last update posted
- 31 May 2013 (estimated)
- Conditions
- Irritable Bowel Syndrome Constipation Predominant
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201020112012
- Ph 1/2
Effects of ROSE-010 on GI Transit in Constipation Predominant Irritable Bowel Syndrome (C-IBS) Patients
NCT01056107Jan 2010 to Dec 2011
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- ROSE-010Drug
- PlaceboDrug
Arms4
Experimental
ROSE-010 30 mcg
A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
Experimental
ROSE-010 100 mcg
A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
Experimental
ROSE-010 300 mcg
A glucagon-like peptide-1 (GLP-1) analogue. A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
Placebo comparator
Placebo
Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
Primary outcomes3
Outcomes the sponsor listed as primary.
Colonic Transit, Colonic Geometric Center at 24 Hours
Time frame · 24 hours (Visit 3 = Day 1)
Registry description
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.
Change Between Postprandial and Fasting Whole Gastric Volume by Technetium-99m (99mTc)-SPECT Imaging (Gastric Accommodation)
Time frame · approximately 1 hour after 99mTC injection, approximately 30 min after liquid meal (Visit 5 = approximately 2-10 days after Visit 4)
Registry description
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 of Solids Measured by Scintigraphy (Gastric Transit)
Time frame · approximately 2 hours after radiolabeled meal is ingested (Visit 2 = Day 0)
Registry description
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.
Secondary outcomes(7)
Gastric Residual at 2 and 4 Hours Measured by Scintigraphy
Time frame · 2 hours, 4 hours (Visit 2 = Day 0)
Registry description
The gastric residual will be calculated as the proportion of isotope remaining in the stomach (at 2 and 4 hours).
Colonic Geometric Center at 4 h Measured by Scintigraphy
Time frame · 4 hours (Visit 2 = Day 0)
Registry description
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.)
Colonic Filling at 6 h Measured by Scintigraphy
Time frame · 6 hours (Visit 2 = Day 0)
Registry description
Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.
Ascending Colon Emptying Half-time (AC t1/2) Measured by Scintigraphy
Time frame · 48 hours (Visit 4 = Day 2)
Registry description
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.
Colonic Transit, Colonic Geometric Center at 48 h Measured by Scintigraphy, as Compared to Placebo.
Time frame · 48 hours (Visit 4 = Day 2)
Registry description
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
Time frame · screening visit (Visit 1), 34 days (Visit 6)
Registry description
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.
Stool Consistency Post Treatment
Time frame · 34 days (Visit 6)
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· approximately 1 hour after 99mTC injection, approximately 30 min after liquid meal (Visit 5 = approximately 2-10 days after Visit 4)
Change Between Postprandial and Fasting Whole Gastric Volume by Technetium-99m (99mTc)-SPECT Imaging (Gastric Accommodation)
| Group | Value (mL) | Spread |
|---|---|---|
| ROSE-010 30 Mcg | 532.2 | 36.6 |
| ROSE-010 100 Mcg | 575.6 | 19.4 |
| ROSE-010 300 Mcg | 515.2 | 52.5 |
| Placebo | 532.8 | 22.8 |
Primary outcomeMean· approximately 2 hours after radiolabeled meal is ingested (Visit 2 = Day 0)
Half Time (t1/2) of Gastric Emptying of Solids Measured by Scintigraphy (Gastric Transit)
| Group | Value (minutes) | Spread |
|---|---|---|
| ROSE-010 30 Mcg | 151.8 | 10.4 |
| ROSE-010 100 Mcg | 172.6 | 7.1 |
| ROSE-010 300 Mcg | 210.7 | 8.6 |
| Placebo | 136.9 | 7.2 |
Secondary and other outcome results(5)
Secondary outcomeMean· 2 hours, 4 hours (Visit 2 = Day 0)
Gastric Residual at 2 and 4 Hours Measured by Scintigraphy
| Group | Value (proportion of isotope in the stomach) | Spread |
|---|---|---|
| ROSE-010 30 Mcg | 0.66 | 0.42 |
| ROSE-010 100 Mcg | 0.76 | 0.03 |
| ROSE-010 300 Mcg | 0.86 | 0.03 |
| Placebo | 0.59 | 0.04 |
Secondary outcomeMean· 4 hours (Visit 2 = Day 0)
Colonic Geometric Center at 4 h Measured by Scintigraphy
| Group | Value (units on a scale) | Spread |
|---|---|---|
| ROSE-010 30 Mcg | 0.70 | 0.20 |
| ROSE-010 100 Mcg | 0.47 | 0.16 |
| ROSE-010 300 Mcg | 0.57 | 0.17 |
| Placebo | 0.53 | 0.17 |
Secondary outcomeMean· 6 hours (Visit 2 = Day 0)
Colonic Filling at 6 h Measured by Scintigraphy
| Group | Value (percentage of meal) | Spread |
|---|---|---|
| ROSE-010 30 Mcg | 47.6 | 7.4 |
| ROSE-010 100 Mcg | 54.4 | 7.8 |
| ROSE-010 300 Mcg | 48.0 | 10.0 |
| Placebo | 53.5 | 4.8 |
Secondary outcomeMean· 48 hours (Visit 4 = Day 2)
Ascending Colon Emptying Half-time (AC t1/2) Measured by Scintigraphy
| Group | Value (hours) | Spread |
|---|---|---|
| ROSE-010 30 Mcg | 14.5 | 1.6 |
| ROSE-010 100 Mcg | 14.8 | 3.7 |
| ROSE-010 300 Mcg | 17.1 | 4.0 |
| Placebo | 19.3 | 3.2 |
Secondary outcomeMean· 48 hours (Visit 4 = Day 2)
Colonic Transit, Colonic Geometric Center at 48 h Measured by Scintigraphy, as Compared to Placebo.
| Group | Value (units on a scale) | Spread |
|---|---|---|
| ROSE-010 30 Mcg | 3.69 | 0.23 |
| ROSE-010 100 Mcg | 3.79 | 0.33 |
| ROSE-010 300 Mcg | 3.36 | 0.37 |
| Placebo | 2.67 | 0.26 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| ROSE-010 30 McgA glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later. | – | 0 / 11 | 6 / 11 |
| ROSE-010 100 McgA glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later. | – | 0 / 11 | 10 / 11 |
| ROSE-010 300 McgA glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later. | – | 0 / 12 | 11 / 12 |
| PlaceboSubjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later. | – | 0 / 12 | 6 / 12 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- ResultCamilleri M, Vazquez-Roque M, Iturrino J, Boldingh A, Burton D, McKinzie S, Wong BS, Rao AS, Kenny E, Mansson M, Zinsmeister AR. Effect of a glucagon-like peptide 1 analog, ROSE-010, on GI motor functions in female patients with constipation-predominant irritable bowel syndrome. Am J Physiol Gastrointest Liver Physiol. 2012 Jul;303(1):G120-8. doi: 10.1152/ajpgi.00076.2012. Epub 2012 Apr 19. PMID 22517769
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 65 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria:
1. Female aged 18-65 years old inclusive.
2. 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:
1. improvement with defecation
2. onset associated with a change in the frequency of stool
3. onset associated with a change in form (appearance) of stool.
3. Constipation predominant type IBS as defined by one or more of the following:
1. fewer than three spontaneous complete bowel movements per week
2. hard or lumpy stools more than 25% of the time
3. straining during a bowel movement more than 25% of the time.
4. A normal rectal exam result on file within the past two years or performed at screen to exclude the possibility of an evacuation disorder. Examination must exclude findings suggestive of an evacuation disorder such as high sphincter tone at rest, failure of perineal descent by more than one centimeter on straining and last, spasm, tenderness or paradoxical contraction of the puborectalis muscles.
5. Females of child bearing potential (those who have not experienced a bilateral tubal ligation, hysterectomy or menopause) must use an acceptable method of contraception during the study. Acceptable methods are surgical sterilization, hormonal methods such as oral contraceptives, Norplant and Depo-Provera, double barrier method such as a condom and spermicide, and an intrauterine device (IUD). Abstinent females may participate if they agree to use the double barrier method should they become sexually active during the study.
6. Able to provide written informed consent prior to any study procedures being performed.
Exclusion Criteria:
1. Female patients who are pregnant or breast-feeding.
2. Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders other than C-IBS.
3. 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.
4. 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.
5. Patients who are considered by the Investigator to be alcoholics not in remission or known substance abusers.
6. Patients who have participated in another clinical study within the past 30 days.
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