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NCT01053962·Phase 2·INTERVENTIONAL

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

PlecanatideOtherCompleted

Status

Completed

Phase

Phase 2

Enrollment

84

Locations

14

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

SP-304 0.3 mg

SP-304 0.3 mg

DRUG

SP-304 1.0 mg

SP-304 1.0 mg

DRUG

SP-304 3.0 mg

SP-304 3.0 mg

DRUG

SP-304 9.0 mg

SP-304 9.0 mg

DRUG

Placebo

Placebo

Timeline

From registration to results.

  1. First posted

    Jan 22, 2010

  2. Study start

    Mar 2010

  3. Primary completion

    Aug 2010

  4. Study completion

    Aug 2010

  5. Results posted

    Jan 2, 2020

  6. Registry updated

    Jan 2, 2020

Outcomes

What the study measures.

Primary outcomes

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 outcomes

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.

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.

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.

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

14 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

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

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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