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The Efficacy of AZD1722 in Constipation Predominant Irritable Bowel Syndrome (IBS-C)

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of AZD1722 for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01923428
Enrollment
356
Registered
2013-08-15
Start date
2013-08-31
Completion date
2014-10-31
Last updated
2020-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation Predominant Irritable Bowel Syndrome

Brief summary

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.

Interventions

DRUGAZD1722
DRUGPlacebo

Sponsors

Ardelyx
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Females and males must agree to use appropriate methods of contraception or be sterile (with appropriate documentation) * Subject is ambulatory * Subject meets definition of IBS-C using Rome III Criteria for the Diagnosis of IBS with a history of \<5 SBMs per week * Subject meets Screening eligibility criteria (see below) * A colonoscopy based on AGA guidelines; every 10 years at ≥ 50 years old, or the occurrence of any warning signs (i.e., unexplained weight loss, non-hemorrhoid blood in stools) * Ability to communicate well with the Investigator and to comply with the requirements of the entire study, including an understanding of how to use the touch-tone telephone electronic diary. * Written informed consent and a willingness to participate in the study as it is described. * Daily access to a touch tone telephone.

Exclusion criteria

* Functional diarrhea as defined by Rome III criteria * IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome III criteria * Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract within 6 months prior to screening, or active disease within 6 months prior to screening. Including but not limited to cancer, inflammatory bowel disease, diverticulitis, duodenal ulcer, erosive esophagitis, gastric ulcer, pancreatitis (within 12 months of screening), cholelithiasis, amyloidosis, ileus, non-controlled GERD, gastrointestinal obstruction or carcinoid syndrome. * 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 within 4 weeks of enrollment, probiotics (including probiotic yogurt); or salt or electrolyte supplements containing sodium, potassium, chloride, or bicarbonate formulations during the seven days prior to treatment; unless specified as rescue medication, and used accordingly. * Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, neurologic, psychiatric or any disease that may interfere with the subject successfully completing the trial. * The subject has a history or current evidence of laxative abuse (in the clinical judgment of the physician). * Hepatic dysfunction (ALT \[SGPT\] or AST \[SGOT\] \>2.5 times the upper limit of normal) or renal impairment (serum creatinine \> 2mg/dL). * Any evidence of or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous year. * Any surgery on the stomach, small intestine or colon, excluding appendectomy. * Pregnant or lactating women. * A major psychiatric disorder (DSM-III-R or DSM-IV) including major depression or other psychoses that has required hospitalization in the last 3 years. History of attempted suicide or uncontrolled bipolar disorder. Alcohol or substance abuse in the last year. * Participation in other clinical trials within 1 month prior to Day -14 (beginning of screening period). * If, in the opinion of the Investigator the subject is unable or unwilling to fulfill the requirements of the protocol or has a condition, which would render the results uninterpretable.

Design outcomes

Primary

MeasureTime frameDescription
Percent Complete Spontaneous Bowel Movement Responders vs Placebo12 weeksWeekly 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

Countries

United States

Participant flow

Participants by arm

ArmCount
5 mg BID
AZD1722
88
20 mg BID
AZD1722
89
50 mg BID
AZD1722
89
Placebo
Placebo
90
Total356

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyAdverse Event8633
Overall StudyLack of Efficacy0011
Overall StudyLost to Follow-up2150
Overall StudyNon Compliance to treatment1201
Overall StudyProtocol Violation3021
Overall StudyWithdrawal by Subject5304

Baseline characteristics

Characteristic5 mg BID20 mg BID50 mg BIDPlaceboTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
4 Participants7 Participants5 Participants9 Participants25 Participants
Age, Categorical
Between 18 and 65 years
84 Participants82 Participants84 Participants81 Participants331 Participants
BMI29.5 kg/m^2
STANDARD_DEVIATION 5.65
28.5 kg/m^2
STANDARD_DEVIATION 5.27
28.3 kg/m^2
STANDARD_DEVIATION 4.87
28.7 kg/m^2
STANDARD_DEVIATION 5.63
28.7 kg/m^2
STANDARD_DEVIATION 5.36
Ethnicity (NIH/OMB)
Hispanic or Latino
22 Participants30 Participants24 Participants29 Participants105 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
66 Participants59 Participants65 Participants61 Participants251 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants3 Participants2 Participants1 Participants6 Participants
Race (NIH/OMB)
Black or African American
18 Participants19 Participants17 Participants22 Participants76 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants1 Participants2 Participants4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
69 Participants67 Participants69 Participants65 Participants270 Participants
Sex: Female, Male
Female
76 Participants77 Participants79 Participants77 Participants309 Participants
Sex: Female, Male
Male
12 Participants12 Participants10 Participants13 Participants47 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
10 / 8813 / 8915 / 894 / 90
serious
Total, serious adverse events
2 / 881 / 890 / 891 / 90

Outcome results

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

Time frame: 12 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
5 mg BIDPercent Complete Spontaneous Bowel Movement Responders vs Placebo35 Participants
20 mg BIDPercent Complete Spontaneous Bowel Movement Responders vs Placebo38 Participants
50 mg BIDPercent Complete Spontaneous Bowel Movement Responders vs Placebo51 Participants
PlaceboPercent Complete Spontaneous Bowel Movement Responders vs Placebo30 Participants
p-value: <0.001Cochran-Mantel-Haenszel

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026