Phase II, Randomized, Placebo-Controlled Study of ATI-7505 in Patients With Chronic Idiopathic Constipation

Study Overview
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Brief Summary
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The purpose of this study is to determine whether ATI-7505 is effective in the treatment of chronic idiopathic constipation.

Detailed Description
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This study is designed to evaluate the safety and efficacy of ATI 7505 in generally healthy, adult patients who have had symptoms of chronic idiopathic constipation for at least 6 months as defined in the ROME III criteria.

Official Title
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A Phase II, Randomized, Placebo-Controlled Study of ATI-7505 in Patients With Chronic Idiopathic Constipation

Conditions
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Chronic Constipation

Intervention / Treatment
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* Drug: ATI-7505
* Drug: ATI-7505
* Drug: ATI-7505
* Drug: ATI-7505
* Drug: ATI-7505


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: written informed consent 18 and 75 years of age constipation symptom onset at least 6 months ago & meet ROME III criteria for chronic constipation negative colonoscopy or air contrast barium enema within the past 2 years if ≥50 years of age or within the past 5 years if <50 years of age; are able to refrain from use of medications known to treat constipation or associated symptoms throughout the study Exclusion Criteria: transabdominal surgery, unstable coronary artery disease, organic gastrointestinal disease, collagen vascular disease, or any alarm symptoms within the 6 months prior to screening; taking prohibited medications (including laxatives, herbal remedies) participating in another drug or medical device study or use of any investigational drug within 30 days before dosing or planning to use prior to study completion; QTcB >440 msec, abnormal 12-lead ECG, family history of sudden death at age <40 years or history of long QT syndrome alcohol or drug abuse within the 6 months prior to screening; autonomic dyssynergic defecation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>placebo twice daily | Drug: ATI-7505<br>* Tablet,placebo, BID<br>|
| Experimental: 2<br>20 mg ATI-7505, BID for 4 weeks | Drug: ATI-7505<br>* ATI-7505 20 mg BID for 4 weeks<br>|
| Experimental: 3<br>40 mg ATI, BID, 4 weeks | Drug: ATI-7505<br>* tablet, 40 mg, BID, $ weeks<br>|
| Experimental: 4<br>80 mg ATI-4505, BID for 4 weeks | Drug: ATI-7505<br>* 80 mg ATI-7505, BID for 4 weeks<br>|
| Experimental: 5<br>120 mg ATI-7505, BID for 4 weeks | Drug: ATI-7505<br>* 120 mg ATI-7505, BID, for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of spontaneous bowel movements during the first 7 days after randomization |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily and/or weekly assessments of the consistency, severity, frequency, symptoms of constipation during the treatment period |  | daily and or weekly |