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

NCT ID: NCT01053962

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-08-31

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.

Conditions

Chronic Idiopathic Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SP-304 0.3 mg

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

Group Type: EXPERIMENTAL

SP-304 0.3 mg

Intervention Type: DRUG

SP-304 0.3 mg

SP-304 1.0 mg

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

Group Type: EXPERIMENTAL

SP-304 1.0 mg

Intervention Type: DRUG

SP-304 1.0 mg

SP-304 3.0 mg

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

Group Type: EXPERIMENTAL

SP-304 3.0 mg

Intervention Type: DRUG

SP-304 3.0 mg

SP-304 9.0 mg

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

Group Type: EXPERIMENTAL

SP-304 9.0 mg

Intervention Type: DRUG

SP-304 9.0 mg

Placebo

Placebo tablet by mouth once daily for 14 consecutive days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

SP-304 0.3 mg

SP-304 0.3 mg

Intervention Type: DRUG

SP-304 1.0 mg

SP-304 1.0 mg

Intervention Type: DRUG

SP-304 3.0 mg

SP-304 3.0 mg

Intervention Type: DRUG

SP-304 9.0 mg

SP-304 9.0 mg

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary S Jacob, Ph.D.

Role: STUDY_DIRECTOR

Synergy Pharmaceuticals Inc.

Locations

Novara Clinical Research

Mesa, Arizona, United States

Genova Clinical Research

Tucson, Arizona, United States

Advanced Clinical Research

Anaheim, California, United States

Advanced Clinical Research

Orange, California, United States

A.G.A. Clinical Trials

Hialeah, Florida, United States

Miami Ressearch and Associates

Miami, Florida, United States

Lee Research Institute

Shawnee Mission, Kansas, United States

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, United States

Universtiy of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Wake Research Associates

Raleigh, North Carolina, United States

Memphis Gastroenterology Group

Germantown, Tennessee, United States

Nashville Medical Research Institute

Nashville, Tennessee, United States

DCOL Center for Clinical Research

Longview, Texas, United States

Pioneer Research Solutions

Sugar Land, Texas, United States

Countries

United States

References

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

Reference Type: RESULT

Other Identifiers

SP-SP304201-09

Identifier Type: -

Identifier Source: org_study_id