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

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ClinicalTrials.gov Identifier: NCT01056107
Recruitment Status : Completed
First Posted : January 26, 2010
Results First Posted : May 31, 2013
Last Update Posted : May 31, 2013
Sponsor:
Collaborators:
Rose Pharma A/S
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Michael Camilleri, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Irritable Bowel Syndrome Constipation Predominant
Interventions Drug: ROSE-010
Drug: Placebo
Enrollment 52
Recruitment Details Subjects were recruited at the Mayo Clinic in Rochester, Minnesota.
Pre-assignment Details 52 subjects were enrolled, but 6 subjects were excluded because they did not meet eligibility criteria.
Arm/Group Title ROSE-010 30 Mcg ROSE-010 100 Mcg ROSE-010 300 Mcg Placebo
Hide Arm/Group Description 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. 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. 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. Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
Period Title: Overall Study
Started 11 11 12 12
Completed 11 10 9 12
Not Completed 0 1 3 0
Reason Not Completed
Withdrawal by Subject             0             1             3             0
Arm/Group Title ROSE-010 30 Mcg ROSE-010 100 Mcg ROSE-010 300 Mcg Placebo Total
Hide Arm/Group Description 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. 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. 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. Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later. Total of all reporting groups
Overall Number of Baseline Participants 11 11 12 12 46
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 11 participants 12 participants 12 participants 46 participants
43.4  (6.0) 40.2  (11.7) 42.0  (11.9) 43.8  (8.0) 42.4  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 12 participants 12 participants 46 participants
Female
11
 100.0%
11
 100.0%
12
 100.0%
12
 100.0%
46
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 11 participants 12 participants 12 participants 46 participants
11 11 12 12 46
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 11 participants 11 participants 12 participants 12 participants 46 participants
27.2  (3.8) 26.4  (5.5) 26.4  (4.8) 27.7  (4.0) 26.9  (4.5)
Stool frequency  
Mean (Standard Deviation)
Unit of measure:  Stools/day
Number Analyzed 11 participants 11 participants 12 participants 12 participants 46 participants
0.7  (0.3) 1.0  (0.8) 0.8  (0.6) 0.7  (0.4) 0.8  (0.5)
Stool Consistency   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 11 participants 11 participants 12 participants 12 participants 46 participants
2.8  (1.1) 3.0  (0.8) 2.8  (1.8) 2.4  (0.9) 2.7  (1.2)
[1]
Measure Description: The subjects rated their stool consistency using the 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.
1.Primary Outcome
Title Colonic Transit, Colonic Geometric Center at 24 Hours
Hide 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.
Time Frame 24 hours (Visit 3 = Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title ROSE-010 30 Mcg ROSE-010 100 Mcg ROSE-010 300 Mcg Placebo
Hide Arm/Group Description:
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.
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.
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.
Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
Overall Number of Participants Analyzed 11 11 12 12
Mean (Standard Error)
Unit of Measure: units on a scale
2.39  (0.22) 2.37  (0.41) 2.02  (0.23) 1.76  (0.14)
2.Primary Outcome
Title Change Between Postprandial and Fasting Whole Gastric Volume by Technetium-99m (99mTc)-SPECT Imaging (Gastric Accommodation)
Hide 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).
Time Frame approximately 1 hour after 99mTC injection, approximately 30 min after liquid meal (Visit 5 = approximately 2-10 days after Visit 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title ROSE-010 30 Mcg ROSE-010 100 Mcg ROSE-010 300 Mcg Placebo
Hide Arm/Group Description:
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.
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.
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.
Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
Overall Number of Participants Analyzed 11 11 12 12
Mean (Standard Error)
Unit of Measure: mL
532.2  (36.6) 575.6  (19.4) 515.2  (52.5) 532.8  (22.8)
3.Primary Outcome
Title Half Time (t1/2) of Gastric Emptying of Solids Measured by Scintigraphy (Gastric Transit)
Hide 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.
Time Frame approximately 2 hours after radiolabeled meal is ingested (Visit 2 = Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title ROSE-010 30 Mcg ROSE-010 100 Mcg ROSE-010 300 Mcg Placebo
Hide Arm/Group Description:
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.
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.
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.
Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
Overall Number of Participants Analyzed 11 11 12 12
Mean (Standard Error)
Unit of Measure: minutes
151.8  (10.4) 172.6  (7.1) 210.7  (8.6) 136.9  (7.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ROSE-010 100 Mcg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0075
Comments [Not Specified]
Method Dunnett's test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ROSE-010 300 Mcg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Dunnett's test
Comments [Not Specified]
4.Secondary Outcome
Title Gastric Residual at 2 and 4 Hours Measured by Scintigraphy
Hide Description The gastric residual will be calculated as the proportion of isotope remaining in the stomach (at 2 and 4 hours).
Time Frame 2 hours, 4 hours (Visit 2 = Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title ROSE-010 30 Mcg ROSE-010 100 Mcg ROSE-010 300 Mcg Placebo
Hide Arm/Group Description:
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.
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.
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.
Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
Overall Number of Participants Analyzed 11 11 12 12
Mean (Standard Error)
Unit of Measure: proportion of isotope in the stomach
Gastric residual at 2 hours 0.66  (0.42) 0.76  (0.03) 0.86  (0.03) 0.59  (0.04)
Gastric residual at 4 hours 0.14  (0.03) 0.16  (0.03) 0.30  (0.06) 0.12  (0.03)
5.Secondary Outcome
Title Colonic Geometric Center at 4 h Measured by Scintigraphy
Hide 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.)
Time Frame 4 hours (Visit 2 = Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title ROSE-010 30 Mcg ROSE-010 100 Mcg ROSE-010 300 Mcg Placebo
Hide Arm/Group Description:
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.
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.
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.
Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
Overall Number of Participants Analyzed 11 11 12 12
Mean (Standard Error)
Unit of Measure: units on a scale
0.70  (0.20) 0.47  (0.16) 0.57  (0.17) 0.53  (0.17)
6.Secondary Outcome
Title Colonic Filling at 6 h Measured by Scintigraphy
Hide Description Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.
Time Frame 6 hours (Visit 2 = Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title ROSE-010 30 Mcg ROSE-010 100 Mcg ROSE-010 300 Mcg Placebo
Hide Arm/Group Description:
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.
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.
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.
Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
Overall Number of Participants Analyzed 11 11 12 12
Mean (Standard Error)
Unit of Measure: percentage of meal
47.6  (7.4) 54.4  (7.8) 48.0  (10.0) 53.5  (4.8)
7.Secondary Outcome
Title Ascending Colon Emptying Half-time (AC t1/2) Measured by Scintigraphy
Hide 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.
Time Frame 48 hours (Visit 4 = Day 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title ROSE-010 30 Mcg ROSE-010 100 Mcg ROSE-010 300 Mcg Placebo
Hide Arm/Group Description:
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.
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.
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.
Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
Overall Number of Participants Analyzed 11 11 12 12
Mean (Standard Error)
Unit of Measure: hours
14.5  (1.6) 14.8  (3.7) 17.1  (4.0) 19.3  (3.2)
8.Secondary Outcome
Title Colonic Transit, Colonic Geometric Center at 48 h Measured by Scintigraphy, as Compared to Placebo.
Hide 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.
Time Frame 48 hours (Visit 4 = Day 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title ROSE-010 30 Mcg ROSE-010 100 Mcg ROSE-010 300 Mcg Placebo
Hide Arm/Group Description:
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.
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.
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.
Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
Overall Number of Participants Analyzed 11 11 12 12
Mean (Standard Error)
Unit of Measure: units on a scale
3.69  (0.23) 3.79  (0.33) 3.36  (0.37) 2.67  (0.26)
9.Secondary Outcome
Title Stool Frequency
Hide 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.
Time Frame screening visit (Visit 1), 34 days (Visit 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title ROSE-010 30 Mcg ROSE-010 100 Mcg ROSE-010 300 Mcg Placebo
Hide Arm/Group Description:
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.
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.
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.
Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
Overall Number of Participants Analyzed 11 11 12 12
Mean (Standard Error)
Unit of Measure: Stools/day
0.75  (0.09) 1.13  (0.17) 0.88  (0.15) 0.70  (0.05)
10.Secondary Outcome
Title Stool Consistency Post Treatment
Hide 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.
Time Frame 34 days (Visit 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title ROSE-010 30 Mcg ROSE-010 100 Mcg ROSE-010 300 Mcg Placebo
Hide Arm/Group Description:
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.
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.
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.
Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
Overall Number of Participants Analyzed 11 11 12 12
Mean (Standard Error)
Unit of Measure: units on a scale
2.93  (0.33) 2.96  (0.36) 2.93  (0.47) 3.05  (0.32)
Time Frame Subjects were assessed for adverse events at every study visit, approximately over 22 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ROSE-010 30 Mcg ROSE-010 100 Mcg ROSE-010 300 Mcg Placebo
Hide Arm/Group Description 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. 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. 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. Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
All-Cause Mortality
ROSE-010 30 Mcg ROSE-010 100 Mcg ROSE-010 300 Mcg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ROSE-010 30 Mcg ROSE-010 100 Mcg ROSE-010 300 Mcg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/11 (0.00%)      0/12 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ROSE-010 30 Mcg ROSE-010 100 Mcg ROSE-010 300 Mcg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/11 (54.55%)      10/11 (90.91%)      11/12 (91.67%)      6/12 (50.00%)    
Gastrointestinal disorders         
Nausea   1/11 (9.09%)  1 8/11 (72.73%)  8 9/12 (75.00%)  9 0/12 (0.00%)  0
Vomiting   0/11 (0.00%)  0 2/11 (18.18%)  2 5/12 (41.67%)  5 1/12 (8.33%)  1
Dry heaving   0/11 (0.00%)  0 0/11 (0.00%)  0 2/12 (16.67%)  2 0/12 (0.00%)  0
Stomach ache   1/11 (9.09%)  1 2/11 (18.18%)  2 1/12 (8.33%)  1 0/12 (0.00%)  0
Abdominal cramp   1/11 (9.09%)  1 1/11 (9.09%)  1 1/12 (8.33%)  1 2/12 (16.67%)  2
Flatulence   0/11 (0.00%)  0 2/11 (18.18%)  2 0/12 (0.00%)  0 2/12 (16.67%)  2
Bloating   2/11 (18.18%)  2 2/11 (18.18%)  2 0/12 (0.00%)  0 1/12 (8.33%)  1
General disorders         
Headache   0/11 (0.00%)  0 3/11 (27.27%)  3 4/12 (33.33%)  4 2/12 (16.67%)  2
Drowsiness   0/11 (0.00%)  0 1/11 (9.09%)  1 3/12 (25.00%)  3 0/12 (0.00%)  0
Lightheadedness   0/11 (0.00%)  0 2/11 (18.18%)  2 1/12 (8.33%)  1 2/12 (16.67%)  2
Skin and subcutaneous tissue disorders         
Injection site rash   1/11 (9.09%)  1 0/11 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michael Camilleri
Organization: Mayo Clinic
Phone: 507-266-2305
EMail: camilleri.michael@mayo.edu
Layout table for additonal information
Responsible Party: Michael Camilleri, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01056107     History of Changes
Other Study ID Numbers: 09-005871
UL1RR024150 ( U.S. NIH Grant/Contract )
First Submitted: January 22, 2010
First Posted: January 26, 2010
Results First Submitted: February 21, 2013
Results First Posted: May 31, 2013
Last Update Posted: May 31, 2013