A Phase II, Randomized, Adaptive Design, Multicenter, Parallel Group, Placebo-controlled, 58-day, Dose-ranging Study of ATI-7505 in Patients with Postprandial Distress Syndrome

• Conditions: Postprandial Distress Syndrome; MedDRA version: 9.1Level: LLTClassification code 10064536Term: Functional dyspepsia

• Registration Number: EUCTR2007-005008-41-BE
• Lead Sponsor: Procter & Gamble Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-19
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 900

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. 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;
d. have experienced early satiety or bothersome postprandial fullness repeatedly during the 3 months prior to screening along with one or more of the following symptoms for PDS:
• early satiety,
• bothersome postprandial fullness,
• upper abdominal bloating or distention,
• postprandial nausea,
• excessive belching;
e. had a normal upper GI endoscopy within the past year (ie, no evidence of erosions or other mucosal abnormalities).
g. if female, are:
• postmenopausal (at least 1 year without spontaneous menses), or
• surgically sterile (tubal ligation or hysterectomy), or
• using highly effective (ICH 1997) contraception (eg, oral, intramuscular, transdermal, or implanted hormonal contraception [at least 3 months prior to enrollment], sexual partner with non-reversed vasectomy [with azoospermia in 2 tests], 2 independent barrier methods [ie, a combination of 2 of the following methods: condom, diaphragm, or properly applied spermicide], or intra-uterine device). Women who are using contraception will be required to have a pregnancy test (urine) at the Screening, Baseline, Day 29, and Day 58 visits;
h. have had no significant changes in diet in the 2 months prior to screening and are not planning such changes for the duration of the study;
i. if taking proton pump inhibitors (PPIs), oral contraceptives, and/or selective serotonin reuptake inhibitors (SSRIs), have been on a stable dose for at least 3 months.

At randomization:

Patients are eligible for randomization to a treatment group in the study if they:

a. have no more than 2 PDS symptom-free days per week during the 2-week run-in period;
b. have an average PDS-symptom score for either primary symptom (early satiety or
bothersome postprandial fullness) of greater than mild severity (>2 on the 1-5 Likert scale) for the 2-week run-in period;
c. have no more than 1 day per week with an EPS-symptom score of greater than moderate severity (>3 on the 1-5 Likert scale) during the 2-week run-in period;
d. have an average EPS score of, at most, mild severity (=2 on the 1-5 Likert scale) for each week of the 2-week run-in period;
e. have no more than 3 days per week with heartburn during the 2-week run-in period;
f. have been at least 70% compliant during the 2-week run-in period with electronic patient reported outcome (ePRO) e-diary entries (at least 10 out of 14 e-diary entries); and
g. have not missed more than 3 consecutive days of e-diary entries.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 body mass index (BMI) >32;
b. current peptic ulcer disease (PUD);
c. heartburn that occurs >3 times per week;
d. 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;
e. a total Patient Health Questionnaire 15-item Somatic Symptom Severity Scale (PHQ-15) score >17
f. presence or suspected presence of unstable coronary artery disease, organic gastrointestinal disease, or collagen vascular disease within the 6 months prior to screening;
g. any alarm symptoms including uninvestigated anemia, rectal bleeding, weight loss, or unresolved fever within the 6 months prior to screening;
h. 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;
i. at screening, a QT interval corrected for heart rate using Bazett’s correction formula (QTcB) >440 msec as determined 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;
j. at the Baseline visit, a QTcB >440 msec as determined by the Investigator;
k. a clinically significant abnormal 12-lead ECG (eg, with evidence of acute or recent
myocardial infarction or ischemia, rhythm disturbance, or conduction abnormality other than first degree AV block);
l. a family history of sudden death at age <40 years;
m. a personal or family history of long QT syndrome;
n. evidence of current or recent alcohol or drug abuse within the 6 months prior to screening;
o. 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;
p. a serum potassium, magnesium, or calcium value outside the laboratory reference range at screening or baseline;
q. a serum aspartate transaminase (AST), alanine transaminase (ALT), or gamma glutamyl transferase (GGT) =3 times the upper limit of the normal laboratory reference range at screening or baseline, or a bilirubin value =2 times the upper limit of the normal laboratory reference range at screening;
r. diabetes mellitus requiring insulin therapy or oral hypoglycemic agents;
s. a hemoglobin A1c (Hgb A1c) >7% at screening;
t. any laboratory value outside the laboratory reference range at screening or baseline that are considered to be clinically significant by the Investigator;
u. a positive pregnancy test or are nursing or planning a pregnancy during screening, run-in, active treatment, or the follow-up period; or
v. a history or presence, upon clinical evaluation, of any illness or condition that might impact the safety of study drug administration or evaluability of drug effect based on the Investigator’s discretion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified