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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00501241

Enrollment

214

Registered

2007-07-16

Start date

2007-07-31

Completion date

2008-07-31

Last updated

2009-06-17

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

Conditions

Chronic Constipation

Brief summary

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

Detailed description

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.

Interventions

DRUGATI-7505

Tablet,placebo, BID

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

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

Design outcomes

Primary

Measure	Time frame
Total number of spontaneous bowel movements during the first 7 days after randomization	7 days

Secondary

Measure	Time frame
Daily and/or weekly assessments of the consistency, severity, frequency, symptoms of constipation during the treatment period	daily and or weekly

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026