A Phase II, Randomized, Placebo-controlled Study of ATI-7505 in Patients with Chronic Idiopathic Constipation

Procter & Gamble Pharmaceuticals0 sites400 target enrollmentFebruary 22, 2008

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Procter & Gamble Pharmaceuticals
Enrollment: 400
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 22, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Procter & Gamble Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

•Inclusion Criteria at Screening:
•Patients are eligible to participate in the study if they:
•a. are willing and able to provide written informed consent;
•b. are male or female between 18 and 75 years of age, inclusive, at screening;
•c. had constipation symptom onset at least 6 months ago;
•d. have for the last 3 months prior to randomization, on average, fewer than 3 bowel
•movements per week along with one or more of the following symptoms of constipation (Drossman 2006\):
•Straining with \=25% of defecations;
•Lumpy or hard stools with \=25% of defecations;
•Sensation of incomplete evacuation \=25% of defecations; or

Exclusion Criteria

•Patients will be excluded from admission to the 2\-week run\-in period or randomization to a treatment group if they have/are:
•a. a history of transabdominal surgery within the 6 months prior to screening;
•b. presence or suspected presence of unstable coronary artery disease, organic gastrointestinal disease, or collagen vascular disease within the 6 months prior to screening;
•c. any alarm symptoms including uninvestigated anemia, rectal bleeding, weight loss, or unresolved fever within the 6 months prior to screening;
•d. taking prohibited medications specified in Section 3\.3 within 30 days prior to screening or planning to take prohibited medications at any time during the study except laxatives used only as rescue medication consistent with protocol section 3\.6\.10;
•e. 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;
•f. at screening, a QT interval corrected for heart rate using Bazett’s correction formula (QTcB) \>440 msec as calculated by the Investigator. The ECG core laboratory will also determine the QTcB and the QT interval corrected for heart rate using Fridericia’s correction formula (QTcF). If either QTcB or QTcF reported by the ECG core laboratory exceeds 440 msec, the patient will not be randomized;
•g. at the baseline visit, a QTcB \>440 msec as calculated by the Investigator;
•h. a clinically significant abnormal 12\-lead ECG with evidence of acute or recent myocardial infarction or ischemia, rhythm disturbance, or conduction abnormality other than first degree AV block;
•i. a family history of sudden death at age \<40 years;