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SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation (CIC)

Primary Purpose

Chronic Idiopathic Constipation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SP-304 0.3 mg
SP-304 1.0 mg
SP-304 3.0 mg
SP-304 9.0 mg
Placebo
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Idiopathic Constipation focused on measuring Chronic Idiopathic Constipation, Constipation, Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novara Clinical Research
  • Genova Clinical Research
  • Advanced Clinical Research
  • Advanced Clinical Research
  • A.G.A. Clinical Trials
  • Miami Ressearch and Associates
  • Lee Research Institute
  • Clinical Research Institute of Michigan, LLC
  • Universtiy of North Carolina at Chapel Hill
  • Wake Research Associates
  • Memphis Gastroenterology Group
  • Nashville Medical Research Institute
  • DCOL Center for Clinical Research
  • Pioneer Research Solutions

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

SP-304 0.3 mg

SP-304 1.0 mg

SP-304 3.0 mg

SP-304 9.0 mg

Placebo

Arm Description

SP-304 0.3 mg tablet by mouth once daily for 14 consecutive days.

SP-304 1.0 mg tablet by mouth once daily for 14 consecutive days.

SP-304 3.0 mg tablet by mouth once daily for 14 consecutive days

SP-304 9.0 mg tablet by mouth once daily for 14 consecutive days.

Placebo tablet by mouth once daily for 14 consecutive days

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events
Incidences of adverse events from Baseline through the end of the Follow-up period.

Secondary Outcome Measures

Change From Baseline Overall in Number of Complete Spontaneous Bowel Movements (CSBM)
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.
Change From Baseline Overall in Number of Spontaneous Bowel Movements (SBM)
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.
Changes From Baseline Overall in Bristol Stool Form Scale (BSFS)
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.
Changes From Baseline Overall in Ease of Passage (Straining)
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

Full Information

First Posted
January 12, 2010
Last Updated
December 16, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01053962
Brief Title
SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation
Acronym
CIC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Constipation
Keywords
Chronic Idiopathic Constipation, Constipation, Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SP-304 0.3 mg
Arm Type
Experimental
Arm Description
SP-304 0.3 mg tablet by mouth once daily for 14 consecutive days.
Arm Title
SP-304 1.0 mg
Arm Type
Experimental
Arm Description
SP-304 1.0 mg tablet by mouth once daily for 14 consecutive days.
Arm Title
SP-304 3.0 mg
Arm Type
Experimental
Arm Description
SP-304 3.0 mg tablet by mouth once daily for 14 consecutive days
Arm Title
SP-304 9.0 mg
Arm Type
Experimental
Arm Description
SP-304 9.0 mg tablet by mouth once daily for 14 consecutive days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet by mouth once daily for 14 consecutive days
Intervention Type
Drug
Intervention Name(s)
SP-304 0.3 mg
Intervention Description
SP-304 0.3 mg
Intervention Type
Drug
Intervention Name(s)
SP-304 1.0 mg
Intervention Description
SP-304 1.0 mg
Intervention Type
Drug
Intervention Name(s)
SP-304 3.0 mg
Intervention Description
SP-304 3.0 mg
Intervention Type
Drug
Intervention Name(s)
SP-304 9.0 mg
Intervention Description
SP-304 9.0 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Incidences of adverse events from Baseline through the end of the Follow-up period.
Time Frame
21 days: Baseline through Follow-up (Treatment Days 14, 7 days post treatment)
Secondary Outcome Measure Information:
Title
Change From Baseline Overall in Number of Complete Spontaneous Bowel Movements (CSBM)
Description
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.
Time Frame
Study days 1 through 14
Title
Change From Baseline Overall in Number of Spontaneous Bowel Movements (SBM)
Description
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.
Time Frame
Study Days 1 through 14
Title
Changes From Baseline Overall in Bristol Stool Form Scale (BSFS)
Description
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.
Time Frame
Study day 1 through 14
Title
Changes From Baseline Overall in Ease of Passage (Straining)
Description
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
Time Frame
Study Days 1 through 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary S Jacob, Ph.D.
Organizational Affiliation
Synergy Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Novara Clinical Research
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Genova Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Advanced Clinical Research
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Advanced Clinical Research
City
Orange
State/Province
California
ZIP/Postal Code
92869
Country
United States
Facility Name
A.G.A. Clinical Trials
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Miami Ressearch and Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Lee Research Institute
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66218
Country
United States
Facility Name
Clinical Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Universtiy of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Memphis Gastroenterology Group
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Nashville Medical Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
DCOL Center for Clinical Research
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Pioneer Research Solutions
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
result

Learn more about this trial

SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation

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