Functional (Non-ulcer) Dyspepsia (FD
Conditions
Interventions
Product Name: r-baclofen (AGI 006)
Product Code: r-baclofen (AGI 006)
Pharmaceutical Form: Tablet
INN or Proposed INN: r-bacolfen (AGI 006)
Current Sponsor code: AGI006-001
Concentration unit: mg mill
Sponsors
AGI Therapeutics Limtied
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: 1. Persistent or recurrent symptoms (pain or discomfort centred in the upper abdomen); 2. May be characterised by or associated with upper abdominal fullness, early satiety, bloating, or nausea; and 3. No evidence of organic disease (including at upper endoscopy) that is likely to explain the symptoms; and 4. 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. 5) Must be able to make entries into a 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 will be excluded from the study if he/she: 1) 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). A urea breath test or the CLO™ test will be used to test for H. pylori infection. 2) 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. 3) Presence or history of biliary tract disease, pancreatitis, colitis, inflammatory bowel disease, irritable bowel syndrome. 4) 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. 5) Has past or present disease likely to complicate the evaluation of the study treatment, e.g. significant cardiovascular, renal or liver disease, or malignancy. 6) Is pregnant or lactating. Women of childbearing potential must maintain effective contraception (See Section 5.4). 7) Uses drugs judged by the Investigator to be the cause of the current episode of dyspeptic symptoms. 8) Needs regular treatment with non-steroidal anti-inflammatory drugs within one month prior to commencing the study. 9) 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. 10) Has evidence of formal psychiatric illness, apart from depression (not major), which is controlled by antidepressants. 11) Has past or present alcohol or drug abuse in the opinion of the Investigator. 12) Has epilepsy. 13) Has Parkinson’s disease 14) Has peptic ulcers or a history of peptic ulcers 15) Has cerebrovascular disease or respiratory, hepatic or renal failure 16) Has hypertension 17) Has autonomic dysreflexia. 18) Has pulmonary insufficiency 19) Has participated in any other clinical trial within the last month. 20) 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 r-baclofen in the treatment of FD (NUD), based on the patient’s global impression. ;Secondary Objective: Secondary objectives 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. ;Primary end point(s): The primary efficacy endpoint will be the percentage of responders to r-baclofen compared to placebo based on the patient’s global impression. | — |
Countries
Ireland, Latvia, Lithuania
Outcome results
None listed