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This phase 2, randomized, double blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of three dose levels of AZD1722 in subjects with constipation predominant IBS (IBS-C) as defined by the ROME III criteria and who have active disease as determined during a two-week screening period. Subjects who qualify and are randomized into the study will receive 5, 20, or 50 mg of AZD1722 BID or placebo BID for 12 consecutive weeks. At the end of this treatment period, subjects will be followed for an additional 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mg BID | Experimental | AZD1722 |
|
| 20 mg BID | Experimental | AZD1722 |
|
| 50 mg BID | Experimental | AZD1722 |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1722 | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Complete Spontaneous Bowel Movement Responders vs Placebo | Weekly complete spontaneous bowel movement resaponders defined as an increase of one or more bowel movement per week from baseline for 6 of the 12 weeks | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David P Rosenbaum, Ph.D. | Ardelyx, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boulder | Colorado | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41601848 | Derived | Lacy BE, Shin AS, Cangemi DJ, Yang Y, Zhao S, Rosenbaum DP. Tenapanor is associated with earlier and sustained symptom relief in IBS-C: a post hoc analysis. Ther Adv Gastroenterol. 2026 Jan 24;19:17562848251414831. doi: 10.1177/17562848251414831. eCollection 2026. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 5 mg BID | AZD1722 |
| FG001 | 20 mg BID | AZD1722 |
| FG002 | 50 mg BID | AZD1722 |
| FG003 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | 5 mg BID | AZD1722 |
| BG001 | 20 mg BID | AZD1722 |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Complete Spontaneous Bowel Movement Responders vs Placebo | Weekly complete spontaneous bowel movement resaponders defined as an increase of one or more bowel movement per week from baseline for 6 of the 12 weeks | Posted | Count of Participants | Participants | 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 5 mg BID | AZD1722 AZD1722 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteomyelitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Development Officer | Ardelyx | 510 745 1752 | drosenbaum@ardelyx.com |
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| ID | Term |
|---|---|
| C000599417 | tenapanor |
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| Placebo |
| Drug |
|
| Greensboro |
| North Carolina |
| United States |
| Winston-Salem | North Carolina | United States |
| Chattanooga | Tennessee | United States |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Non Compliance to treatment |
|
| Lack of Efficacy |
|
| 50 mg BID |
AZD1722 |
| BG003 | Placebo | Placebo |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG003 |
| Placebo |
Placebo |
|
|
|
| 2 |
| 88 |
| 10 |
| 88 |
| EG001 | 20 mg BID | AZD1722 AZD1722 | 1 | 89 | 13 | 89 |
| EG002 | 50 mg BID | AZD1722 AZD1722 | 0 | 89 | 15 | 89 |
| EG003 | Placebo | Placebo | 1 | 90 | 4 | 90 |
| Laryngeal neoplasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
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