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

This study has been completed.
Sponsor:
Information provided by:
Synergy Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01053962
First received: January 12, 2010
Last updated: November 16, 2010
Last verified: November 2010
  Purpose

This is a Phase IIa, 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 Intervention Phase
Chronic Idiopathic Constipation
Drug: SP-304
Drug: Placebo
Drug: SP-304 0.3 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IIa 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

Resource links provided by NLM:


Further study details as provided by Synergy Pharmaceuticals Inc.:

Primary Outcome Measures:
  • To evaluate the safety of SP-304 (1.0 mg, 3.0 mg, 9.0 mg and 0.3 mg) for 14 days in patients with CIC [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess changes in bowel habits over time CSBM, SBM, Stool Consistency, Ease of Passage and Completeness of Evacuation in once daily oral dosing of SP-304 (1.0 mg, 3.0 mg, 9.0 mg and 0.3 mg) vs. placebo for 14 days in patients with CIC [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: February 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SP-304 1.0 mg
Subjects receiving SP-304 1.0 mg for 14 consecutive days
Drug: SP-304
Subjects receiving SP-304 1.0 mg for 14 consecutive days
Experimental: SP-304 3.0 mg
Subjects receiving SP-304 3.0 mg for 14 consecutive days
Drug: SP-304
Subjects receiving SP-304 3.0 mg for 14 consecutive days
Experimental: SP-304 9.0 mg
Subjects receiving SP-304 9.0 mg for 14 consecutive days
Drug: SP-304
Subjects receiving SP-304 9.0 mg for 14 consecutive days
Placebo Comparator: Placebo
Subjects receiving Placebo for 14 consecutive days
Drug: Placebo
Subjects receiving Placebo for 14 consecutive days
Experimental: SP-304 0.3 mg
Subjects receiving SP-304 0.3 mg for 14 consecutive days.
Drug: SP-304 0.3 mg
Subjects receiving SP-304 0.3 mg for 14 consecutive

Detailed Description:

This is a Phase IIa, 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. Subjects diagnosed with chronic idiopathic constipation (CIC) will be screened for the anticipated 4 cohorts, to yield 80 randomized subjects for enrollment. Three dose cohorts are planned (1.0 mg, 3.0mg, 9.0 mg and 0.3 mg) with 20 subjects per dose cohort [randomization ratio 3:1 (15 receive SP-304:5 receive placebo)]. Subjects 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 subject will complete all 14 days of dosing (including making accurate BM diary entries for all 14 days in the treatment period). All subjects receiving at least one dose of SP-304 or matching placebo will be considered evaluable for the safety endpoints. If a subject 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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 (See Appendix A for formula to calculate BMI).
  • Subject meets the Rome III Diagnostic Criteria for functional chronic idiopathic constipation (Drossman, 2006) for the past 3 months with symptom onset > 6 months prior to diagnosis.

Exclusion Criteria:

  • Subject reports loose stool (mushy) or watery stool (BSFS score of 6 or 7) 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: reports abdominal pain or discomfort > 3 days/week in the last 3 months with symptoms onset at > 6 months prior to diagnosis. a2 in the 14-day pre-treatment bowel movement diary.
  • Subject has failed to complete the pre-treatment bowel movement diary accurately and completely during the pre-treatment period prior to Day 1 dosing.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053962

Locations
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, 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
Sugarland, Texas, United States, 77479
Sponsors and Collaborators
Synergy Pharmaceuticals Inc.
Investigators
Study Director: Gary S Jacob, Ph.D. Synergy Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: Craig C. Talluto, Ph.D., Synergy Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01053962     History of Changes
Other Study ID Numbers: SP-SP304201-09
Study First Received: January 12, 2010
Last Updated: November 16, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Synergy Pharmaceuticals Inc.:
Chronic Idiopathic Constipation
Constipation
Irritable Bowel Syndrome

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014