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Tartaric acid is a chemical substance that appears in the EU Clinical Trials Information System as part of a fixed combination product together with metoclopramide hydrochloride, dimeticone, sodium hydrogen carbonate and potassium citrate.[1] The product is authorised as a medicine, and tartaric acid serves as an auxiliary component in the formulation rather than as the main active ingredient.[1]
Metoclopramide, the principal active substance in this combination, is a medicine used to relieve nausea and vomiting. Tartaric acid itself is not the substance being investigated for a new use; it appears in the registry as a supporting ingredient in a cancer trial setting.[1]
The registry records do not describe a mechanism of action for tartaric acid itself. In the combination product, the main active ingredient is metoclopramide, which acts on the digestive system and the brain to reduce nausea and vomiting. Tartaric acid is listed as an auxiliary substance, meaning it supports the formulation rather than providing the main therapeutic effect.[1]
In the trial record, the combination product containing tartaric acid is listed with the route of administration recorded as unknown use and the pharmaceutical form as PHF00169MIG, a coded term in the registry.[1] The product names in the record refer to metoclopramide, the main active ingredient.[1]
One trial in the registry involves the combination product containing tartaric acid. It is a Phase 3 interventional study with 241 participants, currently authorised to proceed.[1] The trial, known as NETTER-3, evaluates the efficacy and safety of [177Lu]Lu-DOTA-TATE (Lutathera) plus octreotide LAR as first-line treatment in patients with Grade 1 and Grade 2 advanced GEP-NET.[1]
The main measure is progression-free survival (PFS), defined as the time from randomisation until the first occurrence of tumor progression — assessed centrally by a Blinded Independent Review Committee according to RECIST v1.1 — or death from any cause.[1] The study aims to demonstrate that the radioactive medicine plus octreotide LAR delays progression or death compared with an active comparator.[1]
Other medicines in the trial include Sandostatin LAR (octreotide) given by intramuscular injection, LysaKare solution for infusion, and octreotide given subcutaneously. Tartaric acid appears only as part of the metoclopramide combination used as a supportive medicine in the trial.[1]
The registry records provided do not include information on side effects specifically attributed to tartaric acid. No supplementary sources on adverse effects were available for this substance.
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