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

Procter & Gamble (P&G) logo

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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