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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01053962
Recruitment Status : Completed
First Posted : January 22, 2010
Results First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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.

Condition or disease Intervention/treatment Phase
Chronic Idiopathic Constipation Drug: SP-304 0.3 mg Drug: SP-304 1.0 mg Drug: SP-304 3.0 mg Drug: SP-304 9.0 mg Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Plecanatide

Arm Intervention/treatment
Experimental: SP-304 0.3 mg
SP-304 0.3 mg tablet by mouth once daily for 14 consecutive days.
Drug: SP-304 0.3 mg
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.
Drug: SP-304 1.0 mg
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
Drug: SP-304 3.0 mg
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.
Drug: SP-304 9.0 mg
SP-304 9.0 mg

Placebo Comparator: Placebo
Placebo tablet by mouth once daily for 14 consecutive days
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Changes From Baseline Overall in Ease of Passage (Straining) [ Time Frame: Study Days 1 through 14 ]
    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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053962


Locations
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United States, Arizona
Novara Clinical Research
Mesa, Arizona, United States, 85206
Genova Clinical Research
Tucson, Arizona, United States, 85741
United States, California
Advanced Clinical Research
Anaheim, California, United States, 92801
Advanced Clinical Research
Orange, California, United States, 92869
United States, Florida
A.G.A. Clinical Trials
Hialeah, Florida, United States, 33012
Miami Ressearch and Associates
Miami, Florida, United States, 33143
United States, Kansas
Lee Research Institute
Shawnee Mission, Kansas, United States, 66218
United States, Michigan
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States, 48047
United States, North Carolina
Universtiy of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Tennessee
Memphis Gastroenterology Group
Germantown, Tennessee, United States, 38138
Nashville Medical Research Institute
Nashville, Tennessee, United States, 37205
United States, Texas
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
Pioneer Research Solutions
Sugar Land, Texas, United States, 77479
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Gary S Jacob, Ph.D. Synergy Pharmaceuticals Inc.
Publications of Results:
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

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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT01053962    
Other Study ID Numbers: SP-SP304201-09
First Posted: January 22, 2010    Key Record Dates
Results First Posted: January 2, 2020
Last Update Posted: January 2, 2020
Last Verified: December 2019
Keywords provided by Bausch Health Americas, Inc.:
Chronic Idiopathic Constipation
Constipation
Irritable Bowel Syndrome
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Plecanatide
Guanylyl Cyclase C Agonists
Enzyme Activators
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents