Actively Recruiting
A 26-Week Study to Assess Safety and Efficacy of Tenapanor for Treating Chronic Idiopathic Constipation in Adults
Led by Ardelyx · Updated on 2026-06-04
692
Participants Needed
109
Research Sites
14 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation (CIC). This study is a 26-week, multi-center, randomized, double-blind, placebo-controlled trial followed by a 4-week treatment-free safety follow-up period. It aims to compare three different doses of tenapanor with a placebo taken twice daily to assess their impact on constipation symptoms. The study includes a 2-week screening period to confirm eligibility, followed by a 26-week randomized treatment period where patients receive either 5 mg, 25 mg, or 50 mg of tenapanor twice daily, or a matching placebo. Patients record their constipation symptoms daily in an electronic diary. After the treatment period, there is a 4-week safety follow-up without treatment to monitor any adverse effects. Participants will have regular visits every 2 to 6 weeks for safety checks including medical assessments, vital signs, ECG, and lab tests. Their symptom diaries will be reviewed throughout the study. The main outcome measured is the durable complete spontaneous bowel movements response at 12 weeks. Secondary outcomes include changes in bowel movement frequency, stool consistency, and straining. The total study duration is approximately 32 weeks including all phases.
CONDITIONS
Brief 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 the Screening visit
- Meet the Rome IV Diagnostic Criteria for functional constipation
- Females of non-childbearing potential or agree to use contraception for 30 days after last dose
- Males must use barrier contraception or have documented surgical sterilization
- Meet entry criteria assessed during Screening
- Able to understand and provide input on electronic diary assessments
- Provide written informed consent before study procedures
- Agree to have daily access to electronic diary via computer, tablet, or smartphone
You will not qualify if you...
- Loose or watery stool without medication affecting stool consistency for more than 25% of bowel movements in the 3 months before Screening
- 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
- Diagnosis or treatment of symptomatic GI abnormalities or active disease within 6 months before Screening
- Central nervous system disorder
- Use of prohibited medications per protocol
- History or current evidence of laxative abuse
- Hepatic dysfunction
- Positive HIV, hepatitis B, or hepatitis C test at Screening
- Positive urinary drug test at Screening except cannabis or cannabidiol
- Malignancy treatment or evidence within 1 year before Screening
- Surgery on stomach, small intestine, or colon within 60 days before Screening (except appendectomy or cholecystectomy)
- Pregnant or planning pregnancy during trial
- Major psychiatric disorder requiring hospitalization in last year
- Alcohol or substance abuse within 1 year before Screening
- Participation in other trials within 1 month before Screening
- Significant disease interfering with study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 26 weeks
Participants receive tenapanor or placebo twice daily and record daily assessments of constipation symptoms via an electronic diary. They attend regular visits for safety assessments.
Visits every 2 to 6 weeks at Weeks 2, 4, 8, 12, 16, 20, and 26
Duration - 4 weeks
Participants are monitored for adverse events during a 4-week treatment-free safety follow-up period and complete a safety assessment visit at the end.
1 follow-up visit at the end of the period
Trial Site Locations
Total: 109 locations
1
G & L Research, LLC
Foley, Alabama, United States, 36535
Actively Recruiting
2
The Center for Clinical Trials
Saraland, Alabama, United States, 36571
Actively Recruiting
3
Arizona Liver Health - Chandler
Chandler, Arizona, United States, 85225
Actively Recruiting
4
Elite Clinical Studies
Phoenix, Arizona, United States, 85018
Actively Recruiting
5
Clinical Research Institute of Arizona, LLC
Sun City West, Arizona, United States, 85375
Actively Recruiting
6
Del Sol Research Management, LLC
Tucson, Arizona, United States, 85715
Actively Recruiting
7
Arkansas Gastroenterology - North Little Rock
North Little Rock, Arkansas, United States, 72117
Actively Recruiting
8
Hope Clinical Research - Canoga Park
Canoga Park, California, United States, 91303
Actively Recruiting
9
GW Research Inc.
Chula Vista, California, United States, 91010
Actively Recruiting
10
Erick H. Alayo Medical Corporation
Chula Vista, California, United States, 91910
Actively Recruiting
11
310 Clinical Research
Inglewood, California, United States, 90301
Actively Recruiting
12
Om Research LLC
Lancaster, California, United States, 93534
Actively Recruiting
13
Clinical Trials Research
Lincoln, California, United States, 95648
Actively Recruiting
14
Acclaim Clinical Research
San Diego, California, United States, 92120
Actively Recruiting
15
San Jose Gastroenterology
San Jose, California, United States, 95128
Actively Recruiting
16
Paragon Rx Clinical, Inc. - Santa Ana
Santa Ana, California, United States, 92703
Actively Recruiting
17
Advanced Research Institute - Denver
Denver, Colorado, United States, 80218
Actively Recruiting
18
Rocky Mountain Gastroenterology (RMG) - Littleton
Lakewood, Colorado, United States, 80228
Actively Recruiting
19
Tekton Research - Longmont, CO
Longmont, Colorado, United States, 80501
Actively Recruiting
20
Proactive Clinical Research
Fort Lauderdale, Florida, United States, 33308
Actively Recruiting
21
Waterway Research
Miami, Florida, United States, 33155
Actively Recruiting
22
Valencia Medical and Research Center
Miami, Florida, United States, 33174
Actively Recruiting
23
IMIC, Inc
Miami, Florida, United States, 33176
Actively Recruiting
24
Harmony Clinical Research, Inc - North Miami Beach
Miami Beach, Florida, United States, 33162
Actively Recruiting
25
Suncoast Clinical Research, Inc. - New Port Richey
New Port Richey, Florida, United States, 34652
Actively Recruiting
26
Sensible Healthcare, LLC
Ocoee, Florida, United States, 34761
Actively Recruiting
27
Harmony Clinical Research - Orlando
Orange City, Florida, United States, 32763
Actively Recruiting
28
Suncoast Clinical Research, Inc. - Palm Harbor
Palm Harbor, Florida, United States, 34684
Actively Recruiting
29
Clinical Research Center of Florida
Pompano Beach, Florida, United States, 33060
Actively Recruiting
30
Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States, 30328
Actively Recruiting
31
DelRicht Clinical Research - Atlanta
Atlanta, Georgia, United States, 30329
Actively Recruiting
32
Gastrointestinal Specialists of Georgia PC
Marietta, Georgia, United States, 30060
Actively Recruiting
33
North Georgia Clinical Research
Woodstock, Georgia, United States, 30189
Actively Recruiting
34
Elite Clinical Trials-Idaho
Blackfoot, Idaho, United States, 83221
Actively Recruiting
35
Treasure Valley Medical Research
Boise, Idaho, United States, 83706
Actively Recruiting
36
GI Alliance - Glenview, IL
Glenview, Illinois, United States, 60026
Actively Recruiting
37
Clinical Investigation Specialists, Inc
Gurnee, Illinois, United States, 60031
Actively Recruiting
38
Southwest Gastroenterology
Oak Lawn, Illinois, United States, 60453
Actively Recruiting
39
Evanston Premier Healthcare Research LLC
Skokie, Illinois, United States, 60077
Actively Recruiting
40
DelRicht Clinical Research - Indianapolis
Indianapolis, Indiana, United States, 46202
Actively Recruiting
41
DelRicht Clinical Research - Overland Park
Overland Park, Kansas, United States, 66209
Actively Recruiting
42
Tekton Research - Wichita, KS
Wichita, Kansas, United States, 67218
Actively Recruiting
43
DelRicht Clinical Research - Louisville
Louisville, Kentucky, United States, 40205
Actively Recruiting
44
Tandem Clinical Research GI - Houma
Houma, Louisiana, United States, 70363
Actively Recruiting
45
DelRicht Clinical Research - Covington
Mandeville, Louisiana, United States, 70471
Actively Recruiting
46
Tandem Clinical Research
Marrero, Louisiana, United States, 70072
Actively Recruiting
47
DelRicht Clinical Research - New Orleans
New Orleans, Louisiana, United States, 70115
Actively Recruiting
48
DelRicht Clinical Research - Prairieville
Prairieville, Louisiana, United States, 70769
Actively Recruiting
49
Delta Research Partners of West Monroe, LLC
West Monroe, Louisiana, United States, 71291
Actively Recruiting
50
Woodholme Gastroenterology
Glen Burnie, Maryland, United States, 21061
Actively Recruiting
51
Elixia SISU BHR - Sprinfield
Springfield, Massachusetts, United States, 01103
Actively Recruiting
52
Bay State Clinical Trials
Watertown, Massachusetts, United States, 02472
Actively Recruiting
53
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
54
DelRicht Clinical Research - Gulfport
Gulfport, Mississippi, United States, 39503
Actively Recruiting
55
Kansas City Research Institute
Kansas City, Missouri, United States, 64131
Actively Recruiting
56
DelRicht Clinical Research - Springfield
Springfield, Missouri, United States, 65807
Actively Recruiting
57
St. Charles Clinical Research
St Louis, Missouri, United States, 63141
Actively Recruiting
58
DelRicht Clinical Research - Town and Country
Town and Country, Missouri, United States, 63017
Actively Recruiting
59
Gastrointestinal Associates LLP
Columbia Falls, Montana, United States, 65201
Actively Recruiting
60
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, United States, 89106
Actively Recruiting
61
Excel Clinical Research
Las Vegas, Nevada, United States, 89109
Actively Recruiting
62
Digestive Disease Specialists
Las Vegas, Nevada, United States, 89128
Actively Recruiting
63
Advanced Research Institute - Reno
Reno, Nevada, United States, 89511
Actively Recruiting
64
Allied Health Clinical Research Organization, LLC (AHCRO) - Jackson
Jackson, New Jersey, United States, 08724
Actively Recruiting
65
Allied Digestive Health - Jersey Shore Gastroenterology - Point Commons
Somers Point, New Jersey, United States, 08244
Actively Recruiting
66
Albuquerque Clinical Trials (ACT)
Albuquerque, New Mexico, United States, 87102
Actively Recruiting
67
NY Scientific
Brooklyn, New York, United States, 11235
Actively Recruiting
68
Drug Trials America
Hartsdale, New York, United States, 10530
Actively Recruiting
69
Accellacare of Cary
Cary, North Carolina, United States, 27518
Actively Recruiting
70
Delricht Clinical Research - Badmus
Charlotte, North Carolina, United States, 28210
Actively Recruiting
71
Coastal Research Institute, LLC
Fayetteville, North Carolina, United States, 28304
Actively Recruiting
72
Peters Medical Research
High Point, North Carolina, United States, 27260
Actively Recruiting
73
Lucas Research - Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina, United States, 28557
Actively Recruiting
74
Accellacare of Raleigh
Raleigh, North Carolina, United States, 27609
Actively Recruiting
75
Accellacare of Rocky Mount
Rocky Mount, North Carolina, United States, 27804
Actively Recruiting
76
Accellacare of Salisbury
Salisbury, North Carolina, United States, 28144
Actively Recruiting
77
Accellacare of Piedmont HealthCare
Statesville, North Carolina, United States, 28625
Actively Recruiting
78
Accellacare of Winston-Salem, Triad Neurological Associates
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
79
Lillestol Research, LLC
Fargo, North Dakota, United States, 58104
Actively Recruiting
80
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
81
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, United States, 43213
Actively Recruiting
82
Remington Davis, Inc.
Columbus, Ohio, United States, 43215
Actively Recruiting
83
Hometown Urgent Care and Research - Huber Heights
Huber Heights, Ohio, United States, 45424
Actively Recruiting
84
Great Lakes Gastroenterology Research
Mentor, Ohio, United States, 44060
Actively Recruiting
85
DelRicht Clinical Research - Tulsa
Tulsa, Oklahoma, United States, 74133
Actively Recruiting
86
Tekton Research - Yukon, OK
Yukon, Oklahoma, United States, 73099
Actively Recruiting
87
Advanced Research Institute - Portland
Tigard, Oregon, United States, 97223
Actively Recruiting
88
DelRicht Clinical Research - Charleston
Charleston, South Carolina, United States, 29407
Actively Recruiting
89
Coastal Carolina Research Center
North Charleston, South Carolina, United States, 29405
Actively Recruiting
90
Accellacare of Bristol
Bristol, Tennessee, United States, 37620
Actively Recruiting
91
DelRicht Clinical Research - Nashville
Hendersonville, Tennessee, United States, 37075
Actively Recruiting
92
New Phase Research & Development - Knoxville
Knoxville, Tennessee, United States, 37909
Actively Recruiting
93
Accellacare of Knoxville
Knoxville, Tennessee, United States, 37938
Actively Recruiting
94
Clinical Neuroscience Solutions, Inc - Memphis
Memphis, Tennessee, United States, 38119
Actively Recruiting
95
Quality Medical Research, PLLC
Nashville, Tennessee, United States, 37211
Actively Recruiting
96
Zenos Clinical Research
Dallas, Texas, United States, 75230
Actively Recruiting
97
EPIC Medical Research
DeSoto, Texas, United States, 75115
Actively Recruiting
98
3A Research
El Paso, Texas, United States, 79925
Actively Recruiting
99
North Hills Medical Research Inc. (North Hills Family Medicine)
North Richland Hills, Texas, United States, 76180
Actively Recruiting
100
LinQ Research, LLC
Pearland, Texas, United States, 77584
Actively Recruiting
101
DelRicht Clinical Research - McKinney
Prosper, Texas, United States, 75078
Actively Recruiting
102
Sun Research Institute
San Antonio, Texas, United States, 78215
Actively Recruiting
103
Texas Gastro Consultants
Tomball, Texas, United States, 77375
Actively Recruiting
104
Advanced Research Institute - Ogden
Ogden, Utah, United States, 84405
Actively Recruiting
105
Wasatch Clinical Research, LLC
Salt Lake City, Utah, United States, 84107
Actively Recruiting
106
Advanced Research Institute - Sandy
Sandy City, Utah, United States, 84092
Actively Recruiting
107
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, United States, 22911
Actively Recruiting
108
Health Research of Hampton Roads, Inc. - Newport News
Newport News, Virginia, United States, 23606
Actively Recruiting
109
DelRicht Clinical Research - Vienn
Vienna, Virginia, United States, 22182
Actively Recruiting
Research Team
M
Marica Tambongco
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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