A Dose-Ranging Study of ATI 7505 in Patients With Postprandial Distress Syndrome

Procter & Gamble (P&G)

Status and phase: Terminated; Phase 2

Conditions: Post Prandial Distress Syndrome

Treatments: Drug: 20 mg ATI 7505; Drug: 80 mg ATI 7505; Drug: 40 mg ATI 7505; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00630370

2007033

Details and patient eligibility

About

To assess the efficacy of 3 oral dosing regimens of ATI 7505 compared to placebo in patients with PDS by comparing at the end of Day 42 the percentage of patients in each treatment group who have had adequate relief of postprandial distress syndrome symptoms on at least 50% of the treatment days.

Enrollment: 6 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Were diagnosed with PDS at least 6 months prior to screening, OR had onset of 2 or more PDS symptoms at least 6 months prior to screening.
• Experienced early satiety or bothersome postprandial fullness repeatedly during the 3 months prior to screening.
• Had a normal upper GI endoscopy within the past year.

Exclusion criteria

• Heartburn that occurs >3 times per week
• Current Helicobacter pylori (H pylori) infection confirmed by stool sample testing or breath testing, or H pylori eradication therapy within the 6 months prior to screening
• Any alarm symptoms including uninvestigated anemia, rectal bleeding, weight loss, or unresolved fever within the 6 months prior to screening
• At screening, a QT interval corrected for heart rate using Bazett's correction formula (QTcB) >440 msec as determined by the Investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Description:

2 Placebo tablets, TID, orally, 58 days

Treatment:

Drug: Placebo

2

Experimental group

Description:

1 ATI 20mg and 1 placebo tablet, TID, orally, 58 days

Treatment:

Drug: 20 mg ATI 7505

3

Experimental group

Description:

1 ATI 40mg and 1 placebo tablet, TID, orally, 58 days

Treatment:

Drug: 40 mg ATI 7505

4

Experimental group

Description:

2 ATI 40mg tablets, TID, orally, 58 days

Treatment:

Drug: 80 mg ATI 7505