Postprandial Distress Syndrome MedDRA version: 9.1 Level: LLT Classification code 10064536 Term: Functional dyspepsia
Conditions
Interventions
Product Name: ATI-7505
Pharmaceutical Form: Tablet
INN or Proposed INN: not assigned yet
CAS Number: 860174-12-5
Current Sponsor code: ATI-7505 dihydrochloride
Other descriptive name: ATI-7505
Concent
Sponsors
Procter & Gamble Pharmaceuticals
Eligibility
Sex/Gender
All
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. 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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 PDS symptoms on at least 50% of the treatment days.;Secondary Objective: - To determine the safety and tolerability of ATI-7505 in patients with PDS; - To determine the time to recurrence of the 2 primary PDS symptoms measured during the 42-day primary efficacy period; and - To determine the effect of ATI-7505 treatment on health-related quality of life (QOL) indices in patients with PDS.;Primary end point(s): The primary efficacy endpoint will be the responder rate for each treatment group through Day 42. Responder rate is defined as the percentage of patients who have adequate symptom relief at least 50% (=50%) of the treatment days during the 42-day primary efficacy period based on daily patient responses via telephone electronic diary (eDiary) to the question, “In the past 24 hours, have you had adequate relief of either or both of these 2 meal-related symptoms: uncomfortable fullness after a meal or the inability to finish a meal?” In this study an adaptive interim efficacy analysis (Bauer and Kohne 1994, Posch et al 2005) will be utilized when 25% and 50% of the planned patients have completed at least 6 weeks of study drug treatment. These analyses will be conducted by an external independent statistician. One of the 4 possible courses of action resulting from the interim analyses is changing the primary efficacy endpoint to the mean score change from baseline over time for the 2 primary PDS symptoms (fullness and early satiety) measured during the 42-day primary efficacy period. If, after an interim analysis, the primary endpoint is changed to the mean change from baseline evaluation, then only patients randomized after the change in the primary endpoint who took at least 1 dose of the study medication will be included in the | — |
Countries
Belgium, Germany, Italy
Outcome results
None listed