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

This study has been completed.
Sponsor:
Collaborators:
Rose Pharma A/S
Information provided by (Responsible Party):
Michael Camilleri, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01056107
First received: January 22, 2010
Last updated: April 24, 2013
Last verified: April 2013
Results First Received: February 21, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Irritable Bowel Syndrome Constipation Predominant
Interventions: Drug: ROSE-010
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited at the Mayo Clinic in Rochester, Minnesota.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
52 subjects were enrolled, but 6 subjects were excluded because they did not meet eligibility criteria.

Reporting Groups
  Description
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.
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.
ROSE-010 300 Mcg 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 Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.

Participant Flow:   Overall Study
    ROSE-010 30 Mcg     ROSE-010 100 Mcg     ROSE-010 300 Mcg     Placebo  
STARTED     11     11     12     12  
COMPLETED     11     10     9     12  
NOT COMPLETED     0     1     3     0  
Withdrawal by Subject                 0                 1                 3                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.
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.
ROSE-010 300 Mcg 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 Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
Total Total of all reporting groups

Baseline Measures
    ROSE-010 30 Mcg     ROSE-010 100 Mcg     ROSE-010 300 Mcg     Placebo     Total  
Number of Participants  
[units: participants]
  11     11     12     12     46  
Age  
[units: years]
Mean ± Standard Deviation
  43.4  ± 6.0     40.2  ± 11.7     42.0  ± 11.9     43.8  ± 8.0     42.4  ± 9.5  
Gender  
[units: participants]
         
Female     11     11     12     12     46  
Male     0     0     0     0     0  
Region of Enrollment  
[units: participants]
         
United States     11     11     12     12     46  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  27.2  ± 3.8     26.4  ± 5.5     26.4  ± 4.8     27.7  ± 4.0     26.9  ± 4.5  
Stool frequency  
[units: Stools/day]
Mean ± Standard Deviation
  0.7  ± 0.3     1.0  ± 0.8     0.8  ± 0.6     0.7  ± 0.4     0.8  ± 0.5  
Stool Consistency [1]
[units: units on a scale]
Mean ± Standard Deviation
  2.8  ± 1.1     3.0  ± 0.8     2.8  ± 1.8     2.4  ± 0.9     2.7  ± 1.2  
[1] 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.



  Outcome Measures
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1.  Primary:   Colonic Transit, Colonic Geometric Center at 24 Hours   [ Time Frame: 24 hours (Visit 3 = Day 1) ]

2.  Primary:   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) ]

3.  Primary:   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) ]

4.  Secondary:   Gastric Residual at 2 and 4 Hours Measured by Scintigraphy   [ Time Frame: 2 hours, 4 hours (Visit 2 = Day 0) ]

5.  Secondary:   Colonic Geometric Center at 4 h Measured by Scintigraphy   [ Time Frame: 4 hours (Visit 2 = Day 0) ]

6.  Secondary:   Colonic Filling at 6 h Measured by Scintigraphy   [ Time Frame: 6 hours (Visit 2 = Day 0) ]

7.  Secondary:   Ascending Colon Emptying Half-time (AC t1/2) Measured by Scintigraphy   [ Time Frame: 48 hours (Visit 4 = Day 2) ]

8.  Secondary:   Colonic Transit, Colonic Geometric Center at 48 h Measured by Scintigraphy, as Compared to Placebo.   [ Time Frame: 48 hours (Visit 4 = Day 2) ]

9.  Secondary:   Stool Frequency   [ Time Frame: screening visit (Visit 1), 34 days (Visit 6) ]

10.  Secondary:   Stool Consistency Post Treatment   [ Time Frame: 34 days (Visit 6) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Michael Camilleri
Organization: Mayo Clinic
phone: 507-266-2305
e-mail: camilleri.michael@mayo.edu


Publications of Results:

Responsible Party: Michael Camilleri, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01056107     History of Changes
Other Study ID Numbers: 09-005871, UL1RR024150
Study First Received: January 22, 2010
Results First Received: February 21, 2013
Last Updated: April 24, 2013
Health Authority: United States: Institutional Review Board