Actively Recruiting
A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
Led by Ardelyx · Updated on 2026-03-17
692
Participants Needed
79
Research Sites
72 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a 26-week, multi-center, randomized, double-blind, placebo-controlled study with a 4-week treatment-free Safety Follow-up period to assess the safety and efficacy of tenapanor (5 mg, 25mg, and 50 mg) in adult patients with Chronic Idiopathic Constipation (CIC) when administered twice daily for 26 consecutive weeks.
CONDITIONS
Official Title
A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 80 years at screening
- Meet Rome IV Diagnostic Criteria for functional constipation
- Females must be non-childbearing or agree to contraception for 30 days after last dose
- Males must agree to use barrier contraception or have surgical sterilization
- Meet all entry criteria during screening
- Able to understand and provide input in electronic diary assessments
- Provide written informed consent before any study procedures
- Agree to daily access to electronic diary via computer, tablet, or smartphone
You will not qualify if you...
- Loose or watery stool without medication for more than 25% of bowel movements in past 3 months
- Fecal impaction within 6 months before screening
- Unexplained, significant alarm symptoms
- Functional diarrhea as per Rome IV criteria
- IBS with constipation, diarrhea, mixed, or unsubtyped IBS per Rome IV criteria
- Clinically symptomatic GI tract abnormalities or active disease within 6 months
- Central nervous system disorder
- Use of prohibited medications per protocol
- History or current evidence of laxative abuse
- Hepatic dysfunction
- Positive HIV, hepatitis B or C test at screening
- Positive drug test except cannabis or cannabidiol
- Evidence or treatment of malignancy within 1 year
- Recent stomach, small intestine, or colon surgery (except appendectomy or cholecystectomy unless within 60 days)
- Pregnant women or planning pregnancy during study
- Major psychiatric disorder requiring hospitalization in past year
- Alcohol or substance abuse in past year
- Participation in other clinical trials within 1 month
- Significant disease interfering with trial completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 79 locations
1
Arizona Liver Health - Chandler
Chandler, Arizona, United States, 85225
Actively Recruiting
2
Elite Clinical Studies
Phoenix, Arizona, United States, 85018
Actively Recruiting
3
Arkansas Gastroenterology - North Little Rock
North Little Rock, Arkansas, United States, 72117
Actively Recruiting
4
Hope Clinical Research - Canoga Park
Canoga Park, California, United States, 91303
Actively Recruiting
5
GW Research Inc.
Chula Vista, California, United States, 91010
Actively Recruiting
6
Erick H. Alayo Medical Corporation
Chula Vista, California, United States, 91910
Actively Recruiting
7
310 Clinical Research
Inglewood, California, United States, 90301
Actively Recruiting
8
Om Research LLC
Lancaster, California, United States, 93534
Actively Recruiting
9
Clinical Trials Research
Lincoln, California, United States, 95648
Actively Recruiting
10
Paragon Rx Clinical, Inc. - Santa Ana
Santa Ana, California, United States, 92703
Actively Recruiting
11
Rocky Mountain Gastroenterology (RMG) - Littleton
Lakewood, Colorado, United States, 80228
Actively Recruiting
12
Proactive Clinical Research
Fort Lauderdale, Florida, United States, 33308
Actively Recruiting
13
Valencia Medical and Research Center
Miami, Florida, United States, 33174
Actively Recruiting
14
IMIC, Inc
Miami, Florida, United States, 33176
Actively Recruiting
15
Suncoast Clinical Research, Inc. - New Port Richey
New Port Richey, Florida, United States, 34652
Actively Recruiting
16
Sensible Healthcare, LLC
Ocoee, Florida, United States, 34761
Actively Recruiting
17
Harmony Clinical Research - Orlando
Orange City, Florida, United States, 32763
Actively Recruiting
18
Suncoast Clinical Research, Inc. - Palm Harbor
Palm Harbor, Florida, United States, 34684
Actively Recruiting
19
Clinical Research Center of Florida
Pompano Beach, Florida, United States, 33060
Actively Recruiting
20
Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States, 30328
Actively Recruiting
21
DelRicht Clinical Research - Atlanta
Atlanta, Georgia, United States, 30329
Actively Recruiting
22
Gastrointestinal Specialists of Georgia PC
Marietta, Georgia, United States, 30060
Actively Recruiting
23
North Georgia Clinical Research
Woodstock, Georgia, United States, 30189
Actively Recruiting
24
Elite Clinical Trials-Idaho
Blackfoot, Idaho, United States, 83221
Actively Recruiting
25
Clinical Investigation Specialists, Inc
Gurnee, Illinois, United States, 60031
Actively Recruiting
26
DelRicht Clinical Research - Indianapolis
Indianapolis, Indiana, United States, 46202
Actively Recruiting
27
DelRicht Clinical Research - Overland Park
Overland Park, Kansas, United States, 66209
Actively Recruiting
28
DelRicht Clinical Research - Louisville
Louisville, Kentucky, United States, 40205
Actively Recruiting
29
Tandem Clinical Research GI - Houma
Houma, Louisiana, United States, 70363
Actively Recruiting
30
DelRicht Clinical Research - Covington
Mandeville, Louisiana, United States, 70471
Actively Recruiting
31
Tandem Clinical Research
Marrero, Louisiana, United States, 70072
Actively Recruiting
32
DelRicht Clinical Research - New Orleans
New Orleans, Louisiana, United States, 70115
Actively Recruiting
33
DelRicht Clinical Research - Prairieville
Prairieville, Louisiana, United States, 70769
Actively Recruiting
34
Delta Research Partners of West Monroe, LLC
West Monroe, Louisiana, United States, 71291
Actively Recruiting
35
Woodholme Gastroenterology
Glen Burnie, Maryland, United States, 21061
Actively Recruiting
36
Elixia SISU BHR - Sprinfield
Springfield, Massachusetts, United States, 01103
Actively Recruiting
37
Bay State Clinical Trials
Watertown, Massachusetts, United States, 02472
Actively Recruiting
38
DelRicht Clinical Research - Gulfport
Gulfport, Mississippi, United States, 39503
Actively Recruiting
39
Kansas City Research Institute
Kansas City, Missouri, United States, 64131
Actively Recruiting
40
DelRicht Clinical Research - Springfield
Springfield, Missouri, United States, 65807
Actively Recruiting
41
St. Charles Clinical Research
St Louis, Missouri, United States, 63141
Actively Recruiting
42
DelRicht Clinical Research - Town and Country
Town and Country, Missouri, United States, 63017
Actively Recruiting
43
Gastrointestinal Associates LLP
Columbia Falls, Montana, United States, 65201
Actively Recruiting
44
Excel Clinical Research
Las Vegas, Nevada, United States, 89109
Actively Recruiting
45
Digestive Disease Specialists
Las Vegas, Nevada, United States, 89128
Actively Recruiting
46
Advanced Research Institute - Reno
Reno, Nevada, United States, 89511
Actively Recruiting
47
Allied Health Clinical Research Organization, LLC (AHCRO) - Jackson
Jackson, New Jersey, United States, 08724
Actively Recruiting
48
Allied Digestive Health - Jersey Shore Gastroenterology - Point Commons
Somers Point, New Jersey, United States, 08244
Actively Recruiting
49
Albuquerque Clinical Trials (ACT)
Albuquerque, New Mexico, United States, 87102
Actively Recruiting
50
NY Scientific
Brooklyn, New York, United States, 11235
Actively Recruiting
51
Drug Trials America
Hartsdale, New York, United States, 10530
Actively Recruiting
52
Delricht Clinical Research - Badmus
Charlotte, North Carolina, United States, 28210
Actively Recruiting
53
Peters Medical Research
High Point, North Carolina, United States, 27260
Actively Recruiting
54
Lucas Research - Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina, United States, 28557
Actively Recruiting
55
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, United States, 43213
Actively Recruiting
56
Remington Davis, Inc.
Columbus, Ohio, United States, 43215
Actively Recruiting
57
Hometown Urgent Care and Research - Huber Heights
Huber Heights, Ohio, United States, 45424
Actively Recruiting
58
Great Lakes Gastroenterology Research
Mentor, Ohio, United States, 44060
Actively Recruiting
59
DelRicht Clinical Research - Tulsa
Tulsa, Oklahoma, United States, 74133
Actively Recruiting
60
Tekton Research - Yukon, OK
Yukon, Oklahoma, United States, 73099
Actively Recruiting
61
Advanced Research Institute - Portland
Tigard, Oregon, United States, 97223
Actively Recruiting
62
DelRicht Clinical Research - Charleston
Charleston, South Carolina, United States, 29407
Actively Recruiting
63
Coastal Carolina Research Center
North Charleston, South Carolina, United States, 29405
Actively Recruiting
64
Accellacare of Bristol
Bristol, Tennessee, United States, 37620
Actively Recruiting
65
DelRicht Clinical Research - Nashville
Hendersonville, Tennessee, United States, 37075
Actively Recruiting
66
New Phase Research & Development - Knoxville
Knoxville, Tennessee, United States, 37909
Actively Recruiting
67
Quality Medical Research, PLLC
Nashville, Tennessee, United States, 37211
Actively Recruiting
68
Zenos Clinical Research
Dallas, Texas, United States, 75230
Actively Recruiting
69
EPIC Medical Research
DeSoto, Texas, United States, 75115
Actively Recruiting
70
3A Research
El Paso, Texas, United States, 79925
Actively Recruiting
71
North Hills Medical Research Inc. (North Hills Family Medicine)
North Richland Hills, Texas, United States, 76180
Actively Recruiting
72
LinQ Research, LLC
Pearland, Texas, United States, 77584
Actively Recruiting
73
DelRicht Clinical Research - McKinney
Prosper, Texas, United States, 75078
Actively Recruiting
74
Sun Research Institute
San Antonio, Texas, United States, 78215
Actively Recruiting
75
Advanced Research Institute - Ogden
Ogden, Utah, United States, 84405
Actively Recruiting
76
Advanced Research Institute - Sandy
Sandy City, Utah, United States, 84092
Actively Recruiting
77
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, United States, 22911
Actively Recruiting
78
Health Research of Hampton Roads, Inc. - Newport News
Newport News, Virginia, United States, 23606
Actively Recruiting
79
DelRicht Clinical Research - Vienn
Vienna, Virginia, United States, 22182
Actively Recruiting
Research Team
J
Jocelyn Tabora
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here