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

NCT01053962 | Completed Phase 2 Results

• 1 other identifier: SP-SP304201-09
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 14

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.

Conditions

Chronic Idiopathic Constipation

Keywords

Chronic Idiopathic Constipation; Constipation; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Incidences of adverse events from Baseline through the end of the Follow-up period.

  21 days: Baseline through Follow-up (Treatment Days 14, 7 days post treatment)

Secondary Outcomes (4)

• Change From Baseline Overall in Number of Complete Spontaneous Bowel Movements (CSBM)

  Study days 1 through 14

• Change From Baseline Overall in Number of Spontaneous Bowel Movements (SBM)

  Study Days 1 through 14

• Changes From Baseline Overall in Bristol Stool Form Scale (BSFS)

  Study day 1 through 14

• Changes From Baseline Overall in Ease of Passage (Straining)

  Study Days 1 through 14

Study Arms (5)

SP-304 0.3 mg

EXPERIMENTAL

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

Drug: SP-304 0.3 mg

SP-304 1.0 mg

EXPERIMENTAL

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

Drug: SP-304 1.0 mg

SP-304 3.0 mg

EXPERIMENTAL

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

Drug: SP-304 3.0 mg

SP-304 9.0 mg

EXPERIMENTAL

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

Drug: SP-304 9.0 mg

Placebo

PLACEBO COMPARATOR

Placebo tablet by mouth once daily for 14 consecutive days

Drug: Placebo

Interventions

SP-304 0.3 mg DRUG

SP-304 0.3 mg

SP-304 0.3 mg

SP-304 1.0 mg DRUG

SP-304 1.0 mg

SP-304 1.0 mg

SP-304 3.0 mg DRUG

SP-304 3.0 mg

SP-304 3.0 mg

SP-304 9.0 mg DRUG

SP-304 9.0 mg

SP-304 9.0 mg

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (14)

Novara Clinical Research

Mesa, Arizona, 85206, United States

Location

Genova Clinical Research

Tucson, Arizona, 85741, United States

Location

Advanced Clinical Research

Anaheim, California, 92801, United States

Location

Advanced Clinical Research

Orange, California, 92869, United States

Location

A.G.A. Clinical Trials

Hialeah, Florida, 33012, United States

Location

Miami Ressearch and Associates

Miami, Florida, 33143, United States

Location

Lee Research Institute

Shawnee Mission, Kansas, 66218, United States

Location

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047, United States

Location

Universtiy of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Memphis Gastroenterology Group

Germantown, Tennessee, 38138, United States

Location

Nashville Medical Research Institute

Nashville, Tennessee, 37205, United States

Location

DCOL Center for Clinical Research

Longview, Texas, 75605, United States

Location

Pioneer Research Solutions

Sugar Land, Texas, 77479, United States

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Constipation; Irritable Bowel Syndrome

Interventions

plecanatide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Limitations and Caveats

This Phase 2a study was not sized to evaluate efficacy.

Results Point of Contact

• Title: Dr. Laura Barrow/Senior Vice President Clinical Development
• Organization: Synergy Pharmaceuticals Inc

lbarrow@synergypharma.com

212-297-0020

Study Officials

• Gary S Jacob, Ph.D.

  Synergy Pharmaceuticals Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 22, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: January 2, 2020
• Results First Posted: January 2, 2020

Record last verified: 2019-12

Locations

US (14)