Functional (Non-ulcer) Dyspepsia MedDRA version: 7.0 Level: PT Classification code 10001394
Conditions
Interventions
Product Name: AGI 001
Product Code: AGI 001
Pharmaceutical Form: Tablet
INN or Proposed INN: Pindolol (S -isomer)
CAS Number: CAS 26328 -1
Current Sponsor code: AGI 001
Concentration unit: mg milligra
Sponsors
AGI Therapeutics Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Be aged 18-70 years 2) Have pain/discomfort centred in the upper abdomen, which may be characterised by or associated with upper abdominal fullness, early satiety, bloating, or nausea on a minimum of 8 days, which need not be consecutive within 8-14 days prior to the randomisation visit. A patient may be considered for randomisation at any time during the run-in period, provided they have had pain/discomfort centred in the upper abdomen on at least 8 days. 3) Fulfil Rome II criteria (modified) for functional dyspepsia i.e. in the last three months symptoms were present often (at least three weeks, at least one day a week) of: a. Persistent or recurrent symptoms (pain or discomfort centred in the upper abdomen); b. May be characterised by or associated with upper abdominal fullness, early satiety, bloating, or nausea; and c. No evidence of organic disease (including at upper endoscopy) that is likely to explain the symptoms; and d. No evidence that dyspepsia is exclusively relieved by defecation or associated with the onset of a change in stool frequency or stool form (i.e., not irritable bowel). 4) Provide signed written informed consent (Attachment 2). 5) Must be able to make entries into a touch tone telephone diary on a daily basis. 6) Must be willing to abstain from taking rescue medication in the run-in phase. 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: A potential participant may be excluded from the study if he/she: 1) Has gastroesophageal reflux disease: a. Known heartburn as the predominant symptom and/or b. Responds to proton pump inhibitors 2) Has H. pylori infection (can be enrolled if eradicated at least 3 months prior to enrolment and patient is negative for H. pylori at this time). The urea breath test or the CLO™ test will be used to test for H. pylori infection. 3) Has an identifiable cause, past or current for the symptoms, where if the disease improves or is eliminated, symptoms also improve. This will be assessed by endoscopy performed within 12 months prior to the randomisation visit, providing there has been no change in the patient’s symptoms during this period and will include: oesophageal, gastric or duodenal cancer, chronic peptic ulcer, oesophagitis (grade 2 or above), oesophageal ulceration or stricture or Barrett’s oesophagitis and evidence of prior oesophageal, gastric or duodenal surgery. 4) Presence or history of biliary tract disease, pancreatitis, colitis, inflammatory bowel disease, irritable bowel syndrome. 5) Requires immediate investigation, such as anaemia, unexplained weight loss, abdominal mass on abdominal examination, melaena, dysphagia, haematemesis or first presentation of symptoms in a patient over 50. 6) Has past or present disease likely to complicate the evaluation of the study treatment, e.g. significant cardiovascular, renal or liver disease, or malignancy. 7) Is pregnant or lactating. Women of childbearing potential must maintain effective contraception (See Section 5.4). 8) Uses drugs judged by the Investigator to be the cause of the current episode of dyspeptic symptoms. 9) Needs regular treatment with non-steroidal anti-inflammatory drugs within one month prior to commencing the study. 10) Uses daily continuous treatment with omeprazole or other proton pump inhibitors, H2-receptor antagonists, prokinetic agents, mucosal preparations, prostaglandin analogues, anticholinergics or drugs likely to alter 5-HT metabolism (e.g. 5-HT reuptake inhibitors, monoamine oxidase inhibitors), bismuth containing drugs within one month prior to commencing the study. 11) Has evidence of formal psychiatric illness, apart from depression (not major), which is controlled by antidepressants. 12) Has past or present alcohol or drug abuse in the opinion of the Investigator. 13) Has any evidence of cardiovascular disease or is taking any medication active on the cardiovascular system, apart from stable low dose (< 75 mg orally/day) aspirin as prophylaxis. 14) Has bronchial asthma 15) Has participated in any other clinical trial within the last month. 16) Has shown previous intolerance/sensitivity to the study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study will be to determine the efficacy of s-pindolol in the treatment of FD (NUD), based on the patient’s global impression;Secondary Objective: Secondary efficacy end-points will include: i) The change from baseline in patient’s global severity of illness scale compared to placebo. ii) The change from baseline in severity of gastrointestinal symptoms scale compared to placebo (upper abdominal pain/discomfort, upper abdominal fullness, early satiety, bloating, nausea, composite of all symptoms). iii) The change from baseline in Quality of Life (QOL) Assessment compared to placebo. iv) The use of rescue medication compared to placebo. Daily data for the patient global impression, patient’s global severity of illness scale, severity of gastrointestinal symptoms scale and rescue medication will be collected for observation purposes. Safety of AGI 001 in doses of 2.5mg, 5mg and 7.5mg t.i.d will be evaluated by assessing adverse events, abnormal laboratory values, heart rate and the mean seated and standing diastolic blood pressure compared to placebo. ;Primary end point(s): The primary efficacy endpoint will be the percentage of responders to s-pindolol compared to placebo based on the patient’s global impression. | — |
Countries
Lithuania, United Kingdom
Outcome results
None listed