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Trial record 2 of 9 for:    plecanatide

An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation

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ClinicalTrials.gov Identifier: NCT03120520
Recruitment Status : Recruiting
First Posted : April 19, 2017
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a study of efficacy and safety of Plecanatide in pediatric subjects aged 12 to < 18 years diagnosed with Chronic Idiopathic Constipation.

Condition or disease Intervention/treatment Phase
Chronic Idiopathic Constipation Drug: Plecanatide Drug: Matching placebo Phase 2

Detailed Description:

The purpose of the study is to evaluate efficacy, safety, and pharmacokinetics (PK) of oral Plecanatide 0.5, 1.0 and 1.5 mg tablets dosed once a day as compared to matching placebo, when administered for 8 weeks in adolescents with chronic idiopathic constipation.

This study will consist of a 4-week screening period, 8 weeks of treatment, and a 2-week follow-up. The study will assess the effects of Plecanatide on bowel movement frequency and other clinical features of CIC.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, 3 Dose Level, Parallel Group Study of the Efficacy and Safety of Plecanatide in Adolescents 12 to < 18 Years of Age With Chronic Idiopathic Constipation (CIC)
Actual Study Start Date : January 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Plecanatide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Plecanatide 0.5 mg
Taken orally once daily in the morning for 8 weeks
Drug: Plecanatide
Other Name: Trulance
Experimental: Plecanatide 1.0 mg
Taken orally once daily in the morning for 8 weeks
Drug: Plecanatide
Other Name: Trulance
Experimental: Plecanatide 1.5 mg
Taken orally once daily in the morning for 8 weeks
Drug: Plecanatide
Other Name: Trulance
Placebo Comparator: Matching placebo
Taken orally once daily in the morning for 8 weeks
Drug: Matching placebo
Other Name: No other names


Outcome Measures

Primary Outcome Measures :
  1. Proportion of Responders for the last 2 weeks of the Treatment Period (responder = a child who experiences >3 Spontaneous Bowel Movements per week for each of the last two weeks of the treatment period) compared to placebo and across treatment groups [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in weekly average stool consistency Bristol Stool Form Scale (BSFS) score, by study week [ Time Frame: 8 weeks ]
  2. Change from baseline in the weekly rate of Spontaneous Bowel Movements (SBM), by study week [ Time Frame: 8 weeks ]
  3. Change from baseline in the weekly rate of Complete Spontaneous Bowel Movements (CSBM), by study week [ Time Frame: 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Male or female adolescents 12 to less than 18 years of age.
  2. Diagnosed with CIC based on the Rome III criteria for child/adolescent functional constipation (Appendix A).
  3. Patient is able to voluntarily provide written, signed, and dated (personally and via a legally authorized representative [LAR]) assent/informed consent as applicable to participate in the study.
  4. Subject's parent/LAR demonstrates an understanding, ability, and willingness to fully comply with study procedures (e.g., accept venipuncture, willing and able to swallow tablets, accept urine drug screen for opiates) and restrictions.

Key Exclusion Criteria:

  1. The patient has a mental age <4 years in the investigator's opinion.
  2. The patient has previously been diagnosed with anorectal malformations, neurological deficits, or anatomical anomalies that would constitute a predisposition to constipation.
  3. The patient currently requires iron supplements, amitriptyline, or other tricyclic antidepressants for depression, opioid-containing medications or compounds for pain, or has other conditions that require medications known to cause constipation. A patient with an onset of constipation prior to the use of these medications and who has been on a stable dose for at least 8 weeks prior to Screening might be considered eligible for this study if the investigator deems these medications do not significantly contribute to the patient's constipation. Screening of these patients needs to be approved by the medical monitor and the sponsor.
  4. The patient, if female of childbearing potential (defined as postmenarche), does not agree to practice 1 of the following medically acceptable methods of birth control throughout the study:

    • Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 1 full cycle (based on the patient's usual menstrual cycle period) before study drug administration.
    • Total abstinence from sexual intercourse since the last menses before study drug administration.
    • Intrauterine device.
    • Double barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream.
  5. The patient follows a diet not considered normal by the investigator for the patient's age, relative to variety of food, caloric content, and quantity. The patient must have been on a stable diet for at least 30 days weeks prior to Screening.
  6. The patient's mobility or normal exercise tolerance is compromised in the investigator's opinion.
  7. The patient has a history of an eating disorder.
Contacts and Locations

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): NCT03120520


Contacts
Contact: Renata Tenenbaum 212-297-0020

  Show 35 Study Locations
Sponsors and Collaborators
Synergy Pharmaceuticals Inc.
More Information

Responsible Party: Synergy Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03120520     History of Changes
Other Study ID Numbers: SP304202-13
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Plecanatide
Gastrointestinal Agents