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Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of IBS-C

Primary Purpose

Irritable Bowel Syndrome With Constipation (IBS-C)

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tenapanor 50 MG
Tenapanor 25 mg bid
Placebo
Sponsored by
Ardelyx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome With Constipation (IBS-C) focused on measuring IBS-C

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥12 and <18 years old Patient weighs ≥18 kg at the time the patient provides written assent Females of child-bearing potential must have negative pregnancy test at Visit 1 (serum) and Visit 2 (urine) and confirm the use of appropriate contraception (including abstinence). Patient meets the Rome IV criteria for child/adolescent diagnosis of IBS-C Patient is willing to discontinue any laxatives used in favor of the protocol-permitted rescue medicine (which will only be allowed after 72 hours with no bowel movement) Patient meets the entry criteria assessed during the 2-week Screening period. Ability of both the patient and parent/guardian/LAR to communicate with the Investigator and to comply with the requirements of the entire study, including an understanding of the assessments in the eDiary and how to use the eDiary device Patient must provide written assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures Exclusion Criteria: Functional diarrhea as defined by Rome IV child/adolescent criteria IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome IV child/adolescent criteria History of non-retentive fecal incontinence. Required manual disimpaction any time prior to randomization (after consent); Has both unexplained and clinically significant alarm symptoms (lower gastrointestinal [GI] bleeding [rectal bleeding or heme-positive stool], iron-deficiency anemia, or any unexplained anemia, or weight loss) and systemic signs of infection or colitis, or any neoplastic process Patient has any of the following conditions: Celiac disease, or positive serological test for celiac disease Cystic fibrosis Hypothyroidism that is untreated or treated with thyroid hormone Down's syndrome or any other chromosomal disorder Active anal fissure Anatomic malformations (eg, imperforate anus) Intestinal nerve or muscle disorders (eg, Hirschprung disease) Neuropathic conditions (eg, spinal cord abnormalities) Lead toxicity, hypercalcemia Neurodevelopmental disabilities producing a cognitive delay that precludes comprehension and completion of the daily eDiary (Electronic handheld device) Inflammatory bowel disease Childhood functional abdominal pain syndrome Childhood functional abdominal pain; Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study; Lactose intolerance that is associated with abdominal pain or discomfort History of cancer other than treated basal cell carcinoma of the skin; (Note: Patients with a history of cancer are allowed provided that the malignancy has been in a complete remission for at least 5 years before the Randomization Visit.) History of diabetic neuropathy. Use of medications that are known to affect stool consistency (Prohibited Medications), including fiber supplements, anti-diarrheals, cathartics, antacids, opiates, prokinetic drugs, laxatives, enemas, antibiotics during the Screening period; unless specified as rescue medication, and used accordingly as directed by the Investigator. Patient has had surgery that meets any of the following criteria: Bariatric surgery for treatment of obesity, or surgery to remove a segment of the GI tract at any time before the Screening Visit; Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit; An appendectomy or cholecystectomy during the 60 days before the Screening Visit; Other major surgery during the 30 days before the Screening Visit History of alcohol or substance abuse Participation in other clinical trials within 1 month prior to Screening Patient and/or parent/guardian/LAR is involved in the conduct and/or administration of this trial as an investigator, sub-investigator, trial coordinator, or other staff member, or the patient is a first-degree family member, significant other, or relative residing with one of the above persons involved in the trial If, in the opinion of the Investigator, the patient is unable or unwilling to fulfill the requirements of the protocol or has a condition, which would render the results uninterpretable

Sites / Locations

  • G & L Research, LLCRecruiting
  • Advanced Research Center, Inc.Recruiting
  • Prohealth Research CenterRecruiting
  • I.H.S. Health, LLCRecruiting
  • Valencia Medical and Research CenterRecruiting
  • Florida Pharmaceutical Research and Associates, Inc.Recruiting
  • Boys Town National Research HospitalRecruiting
  • Med Clinical Research Partners, LLCRecruiting
  • Advantage Clinical TrialsRecruiting
  • SUNY Downstate Medical CenterRecruiting
  • M3 Wake Research, IncRecruiting
  • Frontier Clinical Research, LLCRecruiting
  • Frontier Clinical Research, LLCRecruiting
  • Velocity Clinical Research, ProvidenceRecruiting
  • Prisma Health Children's HospitalRecruiting
  • Texas Digestive SpecialistsRecruiting
  • Texas Digestive SpecialistsRecruiting
  • AIM Trials, LLCRecruiting
  • Sun Research InstituteRecruiting
  • ClinPoint TrialsRecruiting
  • Frontier Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Tenpanor 50 mg BID

Tenpanor 25 mg BID

Placebo Comparator

Arm Description

Patients will be randomized to receive 50 mg tenapanor twice daily

Patients will be randomized to receive 25 mg tenapanor twice daily

Patients will be randomized to receive matching placebo twice daily

Outcomes

Primary Outcome Measures

6/12-week APS (abdominal pain and SBM) +2 response
6/12-week APS (abdominal pain and SBM (spontaneous bowel movement)) +2 response, defined as achieving the weekly APS +2 response criteria (i.e., achieving both weekly SBM +2 response and weekly abdominal pain response during the same week) for ≥6 out of the 12 weeks of the RTP. The weekly SBM +2 response is defined as having an increase of ≥2 from baseline in the average weekly SBM frequency for a given week The weekly abdominal pain response is defined as having ≥30% reduction from baseline in the average weekly abdominal pain score for a given week

Secondary Outcome Measures

6/12-week SBM +2 response
6/12-week SBM +2 response: defined as achieving the weekly SBM +2 response for ≥6 out of the 12 weeks of the RTP
6/12-week abdominal pain response
6/12-week abdominal pain response: defined as achieving the weekly abdominal pain response for ≥6 out of the 12 weeks of the RTP
Change from baseline in average weekly SBM frequency
Change from baseline in average weekly SBM frequency
Change from baseline in average weekly stool consistency score
Change from baseline in average weekly stool consistency score
Change from baseline in average weekly abdominal pain score
Change from baseline in average weekly abdominal pain score
Overall use of rescue medication
Overall use of rescue medication

Full Information

First Posted
November 30, 2022
Last Updated
September 6, 2023
Sponsor
Ardelyx
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1. Study Identification

Unique Protocol Identification Number
NCT05643534
Brief Title
Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of IBS-C
Official Title
A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of Irritable Bowel Syndrome With Constipation (IBS-C) in Pediatric Patients 12 to Less Than 18 Years Old
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
August 29, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ardelyx

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of tenapanor (25 mg and 50 mg) in pediatric patients (≥12 and <18 years old) with IBS-C when administered twice daily (BID) for 12 consecutive weeks.
Detailed Description
This study consists of 2-week screening period followed by 12 week randomized treatment period (RTP). At the beginning of the 2-week Screening period, patients who provide written assent will be fully assessed for eligibility into the study and will be asked to self-report daily information about the status of their IBS symptoms via an electronic diary (eDiary) device. Patient compliance with the eDiary will be monitored actively by the site staff and will be reviewed to determine eligibility at the end of screening. Eligible patients will be randomized to receive one of the study medications: tenapanor 25 mg BID, tenapanor 50 mg BID, or placebo. During the 12-week double-blind RTP, patients will continue recording daily assessments via the eDiary system as instructed and compliance with eDiary entries will be monitored on an ongoing basis. Patients will return for study visit every two or four weeks (Visits 3-6) and will undergo safety assessments at these visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Constipation (IBS-C)
Keywords
IBS-C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tenpanor 50 mg BID
Arm Type
Experimental
Arm Description
Patients will be randomized to receive 50 mg tenapanor twice daily
Arm Title
Tenpanor 25 mg BID
Arm Type
Experimental
Arm Description
Patients will be randomized to receive 25 mg tenapanor twice daily
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Patients will be randomized to receive matching placebo twice daily
Intervention Type
Drug
Intervention Name(s)
Tenapanor 50 MG
Intervention Description
Participants will receive tenapanor 50 mg BID (total of 100 mg daily)
Intervention Type
Drug
Intervention Name(s)
Tenapanor 25 mg bid
Intervention Description
Participants will receive tenapanor 25 mg BID (total of 50 mg daily)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will be randomized to receive matching placebo
Primary Outcome Measure Information:
Title
6/12-week APS (abdominal pain and SBM) +2 response
Description
6/12-week APS (abdominal pain and SBM (spontaneous bowel movement)) +2 response, defined as achieving the weekly APS +2 response criteria (i.e., achieving both weekly SBM +2 response and weekly abdominal pain response during the same week) for ≥6 out of the 12 weeks of the RTP. The weekly SBM +2 response is defined as having an increase of ≥2 from baseline in the average weekly SBM frequency for a given week The weekly abdominal pain response is defined as having ≥30% reduction from baseline in the average weekly abdominal pain score for a given week
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
6/12-week SBM +2 response
Description
6/12-week SBM +2 response: defined as achieving the weekly SBM +2 response for ≥6 out of the 12 weeks of the RTP
Time Frame
12 weeks
Title
6/12-week abdominal pain response
Description
6/12-week abdominal pain response: defined as achieving the weekly abdominal pain response for ≥6 out of the 12 weeks of the RTP
Time Frame
12 weeks
Title
Change from baseline in average weekly SBM frequency
Description
Change from baseline in average weekly SBM frequency
Time Frame
12 weeks
Title
Change from baseline in average weekly stool consistency score
Description
Change from baseline in average weekly stool consistency score
Time Frame
12 weeks
Title
Change from baseline in average weekly abdominal pain score
Description
Change from baseline in average weekly abdominal pain score
Time Frame
12 weeks
Title
Overall use of rescue medication
Description
Overall use of rescue medication
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥12 and <18 years old Patient weighs ≥18 kg at the time the patient provides written assent Females of child-bearing potential must have negative pregnancy test at Visit 1 (serum) and Visit 2 (urine) and confirm the use of appropriate contraception (including abstinence). Patient meets the Rome IV criteria for child/adolescent diagnosis of IBS-C Patient is willing to discontinue any laxatives used in favor of the protocol-permitted rescue medicine (which will only be allowed after 72 hours with no bowel movement) Patient meets the entry criteria assessed during the 2-week Screening period. Ability of both the patient and parent/guardian/LAR to communicate with the Investigator and to comply with the requirements of the entire study, including an understanding of the assessments in the eDiary and how to use the eDiary device Patient must provide written assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures Exclusion Criteria: Functional diarrhea as defined by Rome IV child/adolescent criteria IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome IV child/adolescent criteria History of non-retentive fecal incontinence. Required manual disimpaction any time prior to randomization (after consent); Has both unexplained and clinically significant alarm symptoms (lower gastrointestinal [GI] bleeding [rectal bleeding or heme-positive stool], iron-deficiency anemia, or any unexplained anemia, or weight loss) and systemic signs of infection or colitis, or any neoplastic process Patient has any of the following conditions: Celiac disease, or positive serological test for celiac disease Cystic fibrosis Hypothyroidism that is untreated or treated with thyroid hormone Down's syndrome or any other chromosomal disorder Active anal fissure Anatomic malformations (eg, imperforate anus) Intestinal nerve or muscle disorders (eg, Hirschprung disease) Neuropathic conditions (eg, spinal cord abnormalities) Lead toxicity, hypercalcemia Neurodevelopmental disabilities producing a cognitive delay that precludes comprehension and completion of the daily eDiary (Electronic handheld device) Inflammatory bowel disease Childhood functional abdominal pain syndrome Childhood functional abdominal pain; Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study; Lactose intolerance that is associated with abdominal pain or discomfort History of cancer other than treated basal cell carcinoma of the skin; (Note: Patients with a history of cancer are allowed provided that the malignancy has been in a complete remission for at least 5 years before the Randomization Visit.) History of diabetic neuropathy. Use of medications that are known to affect stool consistency (Prohibited Medications), including fiber supplements, anti-diarrheals, cathartics, antacids, opiates, prokinetic drugs, laxatives, enemas, antibiotics during the Screening period; unless specified as rescue medication, and used accordingly as directed by the Investigator. Patient has had surgery that meets any of the following criteria: Bariatric surgery for treatment of obesity, or surgery to remove a segment of the GI tract at any time before the Screening Visit; Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit; An appendectomy or cholecystectomy during the 60 days before the Screening Visit; Other major surgery during the 30 days before the Screening Visit History of alcohol or substance abuse Participation in other clinical trials within 1 month prior to Screening Patient and/or parent/guardian/LAR is involved in the conduct and/or administration of this trial as an investigator, sub-investigator, trial coordinator, or other staff member, or the patient is a first-degree family member, significant other, or relative residing with one of the above persons involved in the trial If, in the opinion of the Investigator, the patient is unable or unwilling to fulfill the requirements of the protocol or has a condition, which would render the results uninterpretable
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyn Tabora
Phone
510-745-1724
Email
jtabora@ardelyx.com
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Edelstein, PhD
Phone
510-456-7741
Email
sedelstein@ardelyx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Rosenbaum, PhD
Organizational Affiliation
Ardelyx
Official's Role
Study Chair
Facility Information:
Facility Name
G & L Research, LLC
City
Foley
State/Province
Alabama
ZIP/Postal Code
36535
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Fuller
Email
glresearch5@gmail.com
Facility Name
Advanced Research Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Individual Site Status
Recruiting
Facility Name
Prohealth Research Center
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa Bastidas
Email
Vbastidas@prohealthresearchcenter.com
Facility Name
I.H.S. Health, LLC
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jhon Dangond
Facility Name
Valencia Medical and Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yamie Chaviano
Email
ychaviano@valenciamedresearch.com
Facility Name
Florida Pharmaceutical Research and Associates, Inc.
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Abad
Email
mmabad@floridapra.com
Facility Name
Boys Town National Research Hospital
City
Boys Town
State/Province
Nebraska
ZIP/Postal Code
68010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Sack
Facility Name
Med Clinical Research Partners, LLC
City
Irvington
State/Province
New Jersey
ZIP/Postal Code
07111
Country
United States
Individual Site Status
Recruiting
Facility Name
Advantage Clinical Trials
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Individual Site Status
Recruiting
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Individual Site Status
Recruiting
Facility Name
M3 Wake Research, Inc
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Individual Site Status
Recruiting
Facility Name
Frontier Clinical Research, LLC
City
Scottdale
State/Province
Pennsylvania
ZIP/Postal Code
15683
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Provance
Email
lprovance@frontierclinical.com
Facility Name
Frontier Clinical Research, LLC
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Dempsey
Email
jdempsey@frontierclinical.com
Facility Name
Velocity Clinical Research, Providence
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Individual Site Status
Recruiting
Facility Name
Prisma Health Children's Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Digestive Specialists
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Digestive Specialists
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Olvera
Facility Name
AIM Trials, LLC
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charmi Modi
Email
charmi.modi@aimtrials.com
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Mageno
Email
mmageno@sunresearch.com
Facility Name
ClinPoint Trials
City
Waxahachie
State/Province
Texas
ZIP/Postal Code
75165
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherry Johnson
Email
sjohnson@cptrials.com
Facility Name
Frontier Clinical Research
City
Kingwood
State/Province
West Virginia
ZIP/Postal Code
26537
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cearra Appleton
Email
cappleton@frontierclinical.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of IBS-C

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