A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
Purpose
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.
Condition
- Chronic Idiopathic Constipation (CIC)
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patients ≥18 to ≤80 years old at the Screening visit (Visit 1). 2. Meet the Rome IV Diagnostic Criteria for functional constipation. 3. Females of non-childbearing potential, or agree to the use of an acceptable means of contraception for up to 30 days following the last dose of study medication. 4. Males must agree to use an appropriate method of barrier contraception or have documented surgical sterilization. 5. Meets the entry criteria assessed during the Screening period. 6. Ability to understand and provide input on the assessments in the eDiary. 7. Provide written informed consent before the initiation of any study-specific procedures. 8. Must agree to have daily access to eDiary via a computer, tablet or smart phone
Exclusion Criteria
- Loose or watery stool in the absence of any medication that is known to affect stool consistency for >25% of bowel movements (BMs) during the 3 months prior to the Screening visit 2. Fecal impaction within 6 months prior to the Screening visit 3. Unexplained and clinically significant alarm symptoms. 4. Functional diarrhea as defined by Rome IV criteria 5. IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome IV criteria 6. Diagnosis or treatment of any clinically symptomatic abnormality of the GI tract or active disease within 6 months prior to the Screening visit 7. Patient with central nervous system disorder 8. Use of prohibited medications defined by protocol 9. Patient has a history or current evidence of laxative abuse 10. Hepatic dysfunction 11. Positive HIV, hepatitis B or hepatitis C test at screening 12. Positive urinary drug test at Screening, with the exception of cannabis and cannabidiol (CBD) 13. Any evidence of or treatment of malignancy within 1 year prior to the Screening visit 14. Any surgery on the stomach, small intestine or colon; appendectomy or cholecystectomy are not excluded unless within 60 days prior to the Screening visit 15. Pregnant women or women planning to become pregnant during trial participation 16. A major psychiatric disorder that has required hospitalization in the last year prior to the Screening visit. 17. Alcohol or substance abuse within 1 year prior to the Screening visit 18. Participation in other clinical trials within 1 month prior to the Screening visit 19. Clinical evidence of significant disease that may interfere with the patient's successful completion of the trial
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Tenapanor 5 mg BID |
Patients will be randomized to receive 5 mg tenapanor twice daily. |
|
|
Experimental Tenapanor 25 mg BID |
Patients will be randomized to receive 25 mg tenapanor twice daily. |
|
|
Experimental Tenapanor 50 mg BID |
Patients will be randomized to receive 50 mg tenapanor twice daily. |
|
|
Placebo Comparator Placebo Comparator |
Patients will be randomized to receive matching placebo twice daily. |
|
Recruiting Locations
G & L Research, LLC
Foley, Alabama 36535
Foley, Alabama 36535
The Center for Clinical Trials
Saraland, Alabama 36571
Saraland, Alabama 36571
Arizona Liver Health - Chandler
Chandler, Arizona 85225
Chandler, Arizona 85225
Elite Clinical Studies
Phoenix, Arizona 85018
Phoenix, Arizona 85018
Clinical Research Institute of Arizona, LLC
Sun City West, Arizona 85375
Sun City West, Arizona 85375
Del Sol Research Management, LLC
Tucson, Arizona 85715
Tucson, Arizona 85715
Arkansas Gastroenterology - North Little Rock
North Little Rock, Arkansas 72117
North Little Rock, Arkansas 72117
Hope Clinical Research - Canoga Park
Canoga Park, California 91303
Canoga Park, California 91303
GW Research Inc.
Chula Vista, California 91010
Chula Vista, California 91010
Erick H. Alayo Medical Corporation
Chula Vista, California 91910
Chula Vista, California 91910
310 Clinical Research
Inglewood, California 90301
Inglewood, California 90301
Om Research LLC
Lancaster, California 93534
Lancaster, California 93534
Clinical Trials Research
Lincoln, California 95648
Lincoln, California 95648
Acclaim Clinical Research
San Diego, California 92120
San Diego, California 92120
San Jose Gastroenterology
San Jose, California 95128
San Jose, California 95128
Paragon Rx Clinical, Inc. - Santa Ana
Santa Ana, California 92703
Santa Ana, California 92703
Advanced Research Institute - Denver
Denver, Colorado 80218
Denver, Colorado 80218
Rocky Mountain Gastroenterology (RMG) - Littleton
Lakewood, Colorado 80228
Lakewood, Colorado 80228
Tekton Research - Longmont, CO
Longmont, Colorado 80501
Longmont, Colorado 80501
Proactive Clinical Research
Fort Lauderdale, Florida 33308
Fort Lauderdale, Florida 33308
Valencia Medical and Research Center
Miami, Florida 33174
Miami, Florida 33174
Harmony Clinical Research, Inc - North Miami Beach
Miami Beach, Florida 33162
Miami Beach, Florida 33162
Suncoast Clinical Research, Inc. - New Port Richey
New Port Richey, Florida 34652
New Port Richey, Florida 34652
Sensible Healthcare, LLC
Ocoee, Florida 34761
Ocoee, Florida 34761
Harmony Clinical Research - Orlando
Orange City, Florida 32763
Orange City, Florida 32763
Suncoast Clinical Research, Inc. - Palm Harbor
Palm Harbor, Florida 34684
Palm Harbor, Florida 34684
Clinical Research Center of Florida
Pompano Beach, Florida 33060
Pompano Beach, Florida 33060
Agile Clinical Research Trials, LLC
Atlanta, Georgia 30328
Atlanta, Georgia 30328
DelRicht Clinical Research - Atlanta
Atlanta, Georgia 30329
Atlanta, Georgia 30329
Gastrointestinal Specialists of Georgia PC
Marietta, Georgia 30060
Marietta, Georgia 30060
North Georgia Clinical Research
Woodstock, Georgia 30189
Woodstock, Georgia 30189
Elite Clinical Trials-Idaho
Blackfoot, Idaho 83221
Blackfoot, Idaho 83221
Treasure Valley Medical Research
Boise, Idaho 83706
Boise, Idaho 83706
GI Alliance - Glenview, IL
Glenview, Illinois 60026
Glenview, Illinois 60026
Clinical Investigation Specialists, Inc
Gurnee, Illinois 60031
Gurnee, Illinois 60031
Southwest Gastroenterology
Oak Lawn, Illinois 60453
Oak Lawn, Illinois 60453
Evanston Premier Healthcare Research LLC
Skokie, Illinois 60077
Skokie, Illinois 60077
DelRicht Clinical Research - Indianapolis
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
DelRicht Clinical Research - Overland Park
Overland Park, Kansas 66209
Overland Park, Kansas 66209
Tekton Research - Wichita, KS
Wichita, Kansas 67218
Wichita, Kansas 67218
DelRicht Clinical Research - Louisville
Louisville, Kentucky 40205
Louisville, Kentucky 40205
Tandem Clinical Research GI - Houma
Houma, Louisiana 70363
Houma, Louisiana 70363
DelRicht Clinical Research - Covington
Mandeville, Louisiana 70471
Mandeville, Louisiana 70471
Tandem Clinical Research
Marrero, Louisiana 70072
Marrero, Louisiana 70072
DelRicht Clinical Research - New Orleans
New Orleans, Louisiana 70115
New Orleans, Louisiana 70115
DelRicht Clinical Research - Prairieville
Prairieville, Louisiana 70769
Prairieville, Louisiana 70769
Delta Research Partners of West Monroe, LLC
West Monroe, Louisiana 71291
West Monroe, Louisiana 71291
Elixia SISU BHR - Sprinfield
Springfield, Massachusetts 01103
Springfield, Massachusetts 01103
Bay State Clinical Trials
Watertown, Massachusetts 02472
Watertown, Massachusetts 02472
University of Michigan Health System
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
DelRicht Clinical Research - Gulfport
Gulfport, Mississippi 39503
Gulfport, Mississippi 39503
Kansas City Research Institute
Kansas City, Missouri 64131
Kansas City, Missouri 64131
DelRicht Clinical Research - Springfield
Springfield, Missouri 65807
Springfield, Missouri 65807
St. Charles Clinical Research
St Louis, Missouri 63141
St Louis, Missouri 63141
DelRicht Clinical Research - Town and Country
Town and Country, Missouri 63017
Town and Country, Missouri 63017
Gastrointestinal Associates LLP
Columbia Falls, Montana 65201
Columbia Falls, Montana 65201
Jubilee Clinical Research, Inc.
Las Vegas, Nevada 89106
Las Vegas, Nevada 89106
Excel Clinical Research
Las Vegas, Nevada 89109
Las Vegas, Nevada 89109
Digestive Disease Specialists
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Advanced Research Institute - Reno
Reno, Nevada 89511
Reno, Nevada 89511
Allied Health Clinical Research Organization, LLC (AHCRO) - Jackson
Jackson, New Jersey 08724
Jackson, New Jersey 08724
Allied Digestive Health - Jersey Shore Gastroenterology - Point Commons
Somers Point, New Jersey 08244
Somers Point, New Jersey 08244
Albuquerque Clinical Trials (ACT)
Albuquerque, New Mexico 87102
Albuquerque, New Mexico 87102
NY Scientific
Brooklyn, New York 11235
Brooklyn, New York 11235
Drug Trials America
Hartsdale, New York 10530
Hartsdale, New York 10530
Accellacare of Cary
Cary, North Carolina 27518
Cary, North Carolina 27518
Delricht Clinical Research - Badmus
Charlotte, North Carolina 28210
Charlotte, North Carolina 28210
Contact:
Keith Logan
Keith Logan
Coastal Research Institute, LLC
Fayetteville, North Carolina 28304
Fayetteville, North Carolina 28304
Contact:
Brooke Shoffner
910-500-3146
brooke.shoffner@roviaclinical.com; bshoffner@coastalresearchnc.com
Brooke Shoffner
910-500-3146
brooke.shoffner@roviaclinical.com; bshoffner@coastalresearchnc.com
Peters Medical Research
High Point, North Carolina 27260
High Point, North Carolina 27260
Lucas Research - Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina 28557
Morehead City, North Carolina 28557
Accellacare of Raleigh
Raleigh, North Carolina 27609
Raleigh, North Carolina 27609
Accellacare of Rocky Mount
Rocky Mount, North Carolina 27804
Rocky Mount, North Carolina 27804
Accellacare of Salisbury
Salisbury, North Carolina 28144
Salisbury, North Carolina 28144
Accellacare of Piedmont HealthCare
Statesville, North Carolina 28625
Statesville, North Carolina 28625
Accellacare of Winston-Salem, Triad Neurological Associates
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
Lillestol Research, LLC
Fargo, North Dakota 58104
Fargo, North Dakota 58104
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio 43213
Columbus, Ohio 43213
Remington Davis, Inc.
Columbus, Ohio 43215
Columbus, Ohio 43215
Hometown Urgent Care and Research - Huber Heights
Huber Heights, Ohio 45424
Huber Heights, Ohio 45424
Great Lakes Gastroenterology Research
Mentor, Ohio 44060
Mentor, Ohio 44060
DelRicht Clinical Research - Tulsa
Tulsa, Oklahoma 74133
Tulsa, Oklahoma 74133
Tekton Research - Yukon, OK
Yukon, Oklahoma 73099
Yukon, Oklahoma 73099
Advanced Research Institute - Portland
Tigard, Oregon 97223
Tigard, Oregon 97223
DelRicht Clinical Research - Charleston
Charleston, South Carolina 29407
Charleston, South Carolina 29407
Coastal Carolina Research Center
North Charleston, South Carolina 29405
North Charleston, South Carolina 29405
DelRicht Clinical Research - Nashville
Hendersonville, Tennessee 37075
Hendersonville, Tennessee 37075
New Phase Research & Development - Knoxville
Knoxville, Tennessee 37909
Knoxville, Tennessee 37909
Clinical Neuroscience Solutions, Inc - Memphis
Memphis, Tennessee 38119
Memphis, Tennessee 38119
Quality Medical Research, PLLC
Nashville, Tennessee 37211
Nashville, Tennessee 37211
Zenos Clinical Research
Dallas, Texas 75230
Dallas, Texas 75230
EPIC Medical Research
DeSoto, Texas 75115
DeSoto, Texas 75115
North Hills Medical Research Inc. (North Hills Family Medicine)
North Richland Hills, Texas 76180
North Richland Hills, Texas 76180
LinQ Research, LLC
Pearland, Texas 77584
Pearland, Texas 77584
DelRicht Clinical Research - McKinney
Prosper, Texas 75078
Prosper, Texas 75078
Sun Research Institute
San Antonio, Texas 78215
San Antonio, Texas 78215
Texas Gastro Consultants
Tomball, Texas 77375
Tomball, Texas 77375
Advanced Research Institute - Ogden
Ogden, Utah 84405
Ogden, Utah 84405
Wasatch Clinical Research, LLC
Salt Lake City, Utah 84107
Salt Lake City, Utah 84107
Advanced Research Institute - Sandy
Sandy City, Utah 84092
Sandy City, Utah 84092
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia 22911
Charlottesville, Virginia 22911
Health Research of Hampton Roads, Inc. - Newport News
Newport News, Virginia 23606
Newport News, Virginia 23606
DelRicht Clinical Research - Vienn
Vienna, Virginia 22182
Vienna, Virginia 22182
More Details
- Status
- Recruiting
- Sponsor
- Ardelyx
Detailed Description
This study consists of a 2-week Screening period, followed by a 26-week randomized treatment period (RTP), and a 4-week treatment-free Safety Follow-up period. After obtaining study informed consent from patients, the 2-week Screening period starts. Patients will be fully assessed for eligibility into the study. The assessments will include evaluation of inclusion/exclusion criteria, including medical histories, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests. Patients will also self-report, on information about the status of their constipation symptoms and severity via an electronic diary (eDiary). Patient compliance with the eDiary will be monitored to determine eligibility at the end of screening. Eligible patients will be randomized (Visit 2) to receive tenapanor 5 mg BID (twice a day), 25 mg BID, 50 mg BID, or placebo for 26 consecutive weeks as the double-blind RTP. During this period, patients will continue recording daily assessments of constipation symptoms and weekly assessments of constipation severity in the eDiary. Patients will have return visits every two to six weeks at Weeks 2, 4, 8, 12, 16, 20 and 26(Visit 3-9) to undergo safety assessments. Upon completion of the 26-week RTP, patients will be monitored for AEs (adverse events) during the 4-week treatment-free Safety Follow-up period and complete the Follow-up visit (Visit 10) at the end of this period to undergo safety assessments.