DA-9701 on gastric motility in patients with Parkinson's disease: A randomized controlled trial
| Autor: | Jee Young Lee, Yoon Jin Lee, Dong Ho Lee, Cheol Min Shin, Nayoung Kim, Kyung Joon Kim, Jong Min Kim, Yoon Jin Choi |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Male
medicine.medical_specialty Levodopa Parkinson's disease Gastric motility Gastroenterology 030218 nuclear medicine & medical imaging law.invention Antiparkinson Agents 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Double-Blind Method law Internal medicine medicine Humans Aged medicine.diagnostic_test Gastric emptying business.industry Stomach Magnetic resonance imaging Parkinson Disease Middle Aged medicine.disease Magnetic Resonance Imaging Confidence interval Domperidone Treatment Outcome Neurology Gastric Emptying Antiemetics Female Neurology (clinical) Plant Preparations Geriatrics and Gerontology business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Parkinsonismrelated disorders. 54 |
| ISSN: | 1873-5126 |
| Popis: | To evaluate the effect of DA-9701, a novel prokinetic drug, on gastric motility evaluated by magnetic resonance imaging in patients with Parkinson's disease (PD).Forty PD patients were randomly allocated to receive either domperidone or DA-9701. Their gastric functions were evaluated using magnetic resonance imaging before and after 4-week treatment period. Information on levodopa daily dose, disease duration, and Unified PD Rating Scale scores was collected. In 18 patients (domperidone: 9, DA-9701: 9), plasma levodopa concentrations were determined. Primary outcome was assessed by a one-sided 95% confidence interval to show non-inferiority of DA-9701 vs. domperidone with a pre-determined non-inferiority margin of -10%.Thirty-eight participants (19 men and 19 women; mean age, 67.1 years) completed the study protocol (domperidone: DA-9701 = 19:19). Gastric emptying rate at 120 min (2-hr GER) was comparable between the 2 groups; it was not correlated with levodopa daily dose or disease duration or Unified PD Rating Scale scores (all p 0.05). DA-9701 was not inferior to domperidone in changes of 2-hr GERs before and after the treatment (absolute difference, 4.0 %; one-sided 95% confidence interval, - 3.7 to infinity). However, a significant increase in 2-hr GER was observed only in DA-9701 group (54.5% and 61.8%, before and after treatment, respectively, p 0.05). Plasma levodopa concentration showed an insignificant but increasing trend in DA-9701 group. There were neither adverse reactions nor deteriorations of parkinsonian symptoms observed in the study participants.DA-9701 can be used for the patients with PD to enhance gastric motility without aggravating PD symptoms (ClinicalTrials.gov number: NCT03022201). |
| Databáze: | OpenAIRE |
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