- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01053962
SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation (CIC)
December 16, 2019 updated by: Bausch Health Americas, Inc.
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 14-Day Repeat, Oral, Dose Ranging Study to Assess the Safety, Pharmacokinetic and Pharmacodynamic Effects of SP-304 in Patients With Chronic Idiopathic Constipation
This is a Phase 2a, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose ranging study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD) effects of SP-304 in patients with chronic idiopathic constipation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a Phase 2a, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose ranging study to determine the safety, PK and PD effects of SP-304 in patients with chronic idiopathic constipation.
Patients diagnosed with chronic idiopathic constipation (CIC) will be screened for the anticipated 4 cohorts, to yield 80 randomized patients for enrollment.
Four dose cohorts are planned (0.3 mg, 1.0 mg, 3.0mg, and 9.0 mg) with 20 patients per dose cohort [randomization ratio 3:1 (15 receive SP-304:5 receive placebo)].
Patients who continue to meet all the entry criteria and complete the pre-treatment bowel movement (BM) diary will receive, in a double-blind, randomized fashion, SP-304 or matching placebo.
It is expected that each patient will complete all 14 days of dosing (including making accurate BM diary entries for all 14 days in the treatment period).
All patients receiving at least one dose of SP-304 or matching placebo will be considered evaluable for the safety endpoints.
If a patient receives at least 5 doses per treatment week (1 dose per day for 7 days) and has completed BM diary entries for those 5 dosing days in each corresponding treatment week, he/she will be considered evaluable.
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Mesa, Arizona, United States, 85206
- Novara Clinical Research
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Tucson, Arizona, United States, 85741
- Genova Clinical Research
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California
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Anaheim, California, United States, 92801
- Advanced Clinical Research
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Orange, California, United States, 92869
- Advanced Clinical Research
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Florida
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Hialeah, Florida, United States, 33012
- A.G.A. Clinical Trials
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Miami, Florida, United States, 33143
- Miami Ressearch and Associates
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Kansas
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Shawnee Mission, Kansas, United States, 66218
- Lee Research Institute
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Michigan
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Chesterfield, Michigan, United States, 48047
- Clinical Research Institute of Michigan, LLC
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Universtiy of North Carolina at Chapel Hill
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Raleigh, North Carolina, United States, 27612
- Wake Research Associates
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Tennessee
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Germantown, Tennessee, United States, 38138
- Memphis Gastroenterology Group
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Nashville, Tennessee, United States, 37205
- Nashville Medical Research Institute
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Texas
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Longview, Texas, United States, 75605
- DCOL Center for Clinical Research
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Sugar Land, Texas, United States, 77479
- Pioneer Research Solutions
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject is able to understand and willing to sign the Informed Consent Form (ICF) and capable of providing written authorization for use and disclosure of protected health information per requirements of 45 CFR 164.508 (Health Insurance Portability and Accountability Act [HIPAA]).
- Subject is male or non-pregnant, non-breastfeeding female, between 18 and 75 years of age (inclusive) at the time of first dose.
- Subject has a body mass index (BMI) between 18 and 35 kg/m2.
- Subject meets the Rome III Diagnostic Criteria for constipation (Drossman, 2006) for the past 3 months with symptom onset > 6 months prior to diagnosis.
Exclusion Criteria:
- Subject reports loose stool (fluffy pieces with ragged edges, a mushy stool) or watery stool (no solid pieces, entirely liquid; BSFS score of 6 or 7, respectively) in the absence of any laxative, enema, suppository or prohibited medicine for > 25% of BMs during the 3 months prior to the Screening visit and during the 14 day pre-treatment period.
- Subjects who meet the Rome III criteria for IBS.
- Subject has failed to complete the pre-treatment bowel movement diary accurately and completely during the pre-treatment period prior to Day 1 dosing.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SP-304 0.3 mg
SP-304 0.3 mg tablet by mouth once daily for 14 consecutive days.
|
SP-304 0.3 mg
|
Experimental: SP-304 1.0 mg
SP-304 1.0 mg tablet by mouth once daily for 14 consecutive days.
|
SP-304 1.0 mg
|
Experimental: SP-304 3.0 mg
SP-304 3.0 mg tablet by mouth once daily for 14 consecutive days
|
SP-304 3.0 mg
|
Experimental: SP-304 9.0 mg
SP-304 9.0 mg tablet by mouth once daily for 14 consecutive days.
|
SP-304 9.0 mg
|
Placebo Comparator: Placebo
Placebo tablet by mouth once daily for 14 consecutive days
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events
Time Frame: 21 days: Baseline through Follow-up (Treatment Days 14, 7 days post treatment)
|
Incidences of adverse events from Baseline through the end of the Follow-up period.
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21 days: Baseline through Follow-up (Treatment Days 14, 7 days post treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline Overall in Number of Complete Spontaneous Bowel Movements (CSBM)
Time Frame: Study days 1 through 14
|
Using a Daily Diary, patients recorded the number of spontaneous bowel movements having the sensation of complete evacuation (Complete Spontaneous Bowel Movement - CSBM).
The total number of spontaneous bowel movements associated with a feeling of complete evacuation were summed and divided by 2 (the number of weeks in treatment).
Change was calculated as the difference between the number of the CSBMs at the completion of the 2-week treatment period, versus the 14-day pretreatment baseline.
|
Study days 1 through 14
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Change From Baseline Overall in Number of Spontaneous Bowel Movements (SBM)
Time Frame: Study Days 1 through 14
|
Using a Daily Diary, patients recorded the number of spontaneous bowel movements (SBM).
The overall weekly frequency was calculated as the total number of SBMs divided by 2 (the number weeks of treatment).
Change was calculated as the difference between the number of the SBMs at the completion of the 2-week treatment period, versus the 14-day pretreatment baseline.
|
Study Days 1 through 14
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Changes From Baseline Overall in Bristol Stool Form Scale (BSFS)
Time Frame: Study day 1 through 14
|
Using a Daily Diary, patients recorded Stool Consistency using the 7-point Bristol Stool Form Scale (BSFS) (1 = separate hard lumps, like nuts; 2 sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges; 6 = fluffy pieces with ragged edges, a mushy stool; 7 = watery, no solid pieces, entirely liquid).
Changes in mean BSFS were assessed from the average 14-day pretreatment baseline to the average during the 2-week treatment period.
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Study day 1 through 14
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Changes From Baseline Overall in Ease of Passage (Straining)
Time Frame: Study Days 1 through 14
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Using a Daily Diary, patients recorded Ease of Passage (Straining) using the 7-point Ease-of-Passage Scale (1 = manual disimpaction/enema needed, 2 = severe straining, 3 = moderate straining, 4 = mild straining, 5 = no straining, 6 = urgency, 7 = incontinent).
Changes in overall ease of passage (Straining) were assessed from the average 14-day pretreatment baseline to average during the 2-week treatment period
|
Study Days 1 through 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Gary S Jacob, Ph.D., Synergy Pharmaceuticals Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Shailubhai K, Talluto C, Comiskey S, Foss J, Joslyn A, Jacob G. Phase II Clinical Evaluation of SP-304, a Guanylate Cyclase-C Agonist, for Treatment of Chronic Constipation. Am J Gastroenterology 105 (Supp 1): S487, 2010
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
January 12, 2010
First Submitted That Met QC Criteria
January 21, 2010
First Posted (Estimate)
January 22, 2010
Study Record Updates
Last Update Posted (Actual)
January 2, 2020
Last Update Submitted That Met QC Criteria
December 16, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SP-SP304201-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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