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View Clinical Trial (Medical Research Study)
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Effects of ROSE-010 on GI Transit in Constipation Predominant Irritable Bowel Syndrome (C-IBS) Patients - NCT01056107-55905 (Clinical Trial 480437)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy480437.aspx
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| City: |
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Rochester |
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State:
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MN |
| Zip Code: |
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55905 |
| Conditions: |
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Irritable Bowel Syndrome Constipation Predominant |
| Purpose: |
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This is a single-center, randomized, parallel group, double-blind, placebo-controlled, dose
response, pharmacodynamic and pharmacokinetic study evaluating the effects of ROSE-010 on
gastric, intestinal and colonic transit and gastric volumes in female patients with C- IBS.
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| Study summary: |
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Methodology
Female patients with C-IBS will be screened for eligibility and informed about the study at
the initial screening visit Visit 1. Within two weeks of Visit 1, eligible patients will be
randomized to study medication, either 30 mcg, 100 mcg or 300 mcg ROSE-010 or placebo
administered via abdominal s.c injection for a total of four days, three consecutive days
during transit scintigraphy and once prior to SPECT imaging. The allocation to treatment
group will be concealed.
Study medication will be administered at the Charlton 7 Clinical Research Unit (CRU) at
Visits 2, 3, and 4, the days of scintigraphic assessment of gastric, small bowel and colonic
transit of solids performed over a 48 hour period.
Within two to seven days of Visit 4, patients will be instructed to return to the Charlton 7
CRU for administration of a final injection of study medication followed by SPECT gastric
accommodation measurements (Visit 5). Within seven to ten days of Visit 5, patients will
return for Visit 6, final safety monitoring and an exit interview with study staff.
Investigational product, dosage and mode of administration
Patients will receive placebo or 30 mcg, 100 mcg or 300 mcg ROSE-010 administered s.c. in
the abdomen once on Visit 2, immediately before the standardized breakfast meal, fifteen
minutes before the first camera image is obtained. Study medication will be administered
fifteen minutes before camera images obtained on Visits 3 and 4. Study medication will be
administered immediately after the first fasting scan is obtained and before the second
fasting scan during SPECT at Visit 5. Study medication will be administered at Charlton 7
CRU by CRU nurses.
Duration of treatment
ROSE-010 or matching placebo will be administered via abdominal s.c injection once daily for
three consecutive days and one final day two to seven days later, over a ten-day interval.
Duration of patients involvement in the study
Each patient will attend six visits at the clinic during a period of two to four weeks.
Efficacy assessments
1. Scintigraphic gastrointestinal and colonic transit
2. 99mTc SPECT measurement of gastric volumes
3. Assessment of stool frequency and consistency made by the patient using the Bowel
Pattern Diary
Safety assessments
The following safety assessments will be performed:
1. Laboratory safety tests, including a complete blood count (CBC), a comprehensive
metabolic panel (CMP), and urinalysis (UA) at Visit 1 (study entry) and Visit 6 (study
exit)
2. A physical examination by a study physician at Visit 1
3. Weight and vital signs (including temperature, pulse, blood pressure and respiration
rate) at every visit
4. Urine pregnancy tests performed at Visit 1 and within 48 hours prior to receipt of
radiation at Visit 2 transit test and Visit 5 SPECT test
5. Interview for concomitant medications and adverse events at every visit
Statistical methods
An analysis of covariance (ANCOVA) will be used to compare transit parameters and gastric
volumes among the treatment groups. If necessary a suitable transformation for potential
skewness in the distributions of measured volumes may be used (e.g., ANCOVA on ranks or log
volumes). If ANCOVA shows a p value less than or equal to 0.10, then both the 100 mcg and
300 mcg doses will be compared to placebo (p value less than or equal to 0.25). Dunnett's
Test will be used to compare each dose group with placebo. Since each of the primary
endpoints assesses a separate hypothesis regarding the effects of ROSE-010, no adjustment in
the alpha level for testing multiple types of endpoints is anticipated, and a two-sided
significance level of 0.05 will be used in each ANCOVA model.
Analysis data sets
The primary analyses will follow the intent to treat (ITT) paradigm with all patients
randomized included in the analyses. Those patients with missing response values will have
their missing values imputed via the overall (patients with non-missing data) mean and a
corresponding adjustment in the ANCOVA residual error variance degrees of freedom
(subtracting one for each missing value imputed). Safety data will be presented for all
patients receiving investigational product. |
| Criteria: |
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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 : a. improvement with
defecation b. onset associated with a change in the frequency of stool c. onset
associated with a change in form (appearance) of stool
3. Constipation predominant type IBS as defined by one or more of the following : a.
fewer than three spontaneous complete bowel movements per week b. hard or lumpy
stools more than 25 % of the time c. 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 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 SNRIs; analgesic drugs including opiates, 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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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
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