TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03428230
Drug: 60 mg Paracetamol 3% (2 mL)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.
Study: NCT02253914
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03428230
Drug: 90 mg Paracetamol 3% (3 mL)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.
Study: NCT00435409
Drug: Sunitinib + Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen.~Capecitabine administered orally at a starting dose of 2000 mg/m\^2 per day \[1000 mg/m\^2 bid (twice daily)\] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons.
Study: NCT00435409
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Capecitabine administered orally at a starting dose of 2500 mg/m\^2 per day \[1250 mg/m\^2 bid (twice daily)\] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons. At the time of progression, patients may be eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily.
Study: NCT04474470
Drug: NT219
Normalized name: NT219
Approvals — FDA: no, EMA: no, PMDA: no
Description: Dose escalation of NT219 as a single agent in adult subjects with recurrent and/or metastatic solid tumors
Study: NCT04474470
Drug: NT219 and ERBITUX® - Dose Escalation
Approvals — FDA: no, EMA: no, PMDA: no
Description: Dose escalation of NT219 in combination with standard dose ERBITUX® in adult subjects with recurrent and/or metastatic squamous cell carcinoma of the head and neck and colorectal adenocarcinoma
Study: NCT04474470
Drug: NT219 and ERBITUX® - Expansion
Approvals — FDA: no, EMA: no, PMDA: no
Description: Expansion cohort of NT219 at its RP2D in combination with standard dose ERBITUX® in adult patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck
Study: NCT02113267
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 4 spray doses à 50 micrograms by mouth to be swallowed 4 times daily after meals (9) with no eating or drinking allowed 30 minutes after intake. Duration of treatment is 8 weeks.
Study: NCT03428230
Drug: Placebo, 0.9% saline solution
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.
Study: NCT01279668
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: tablets, once per day for 28 days.
Study: NCT00903162
Drug: zoledronic acid
Normalized name: Zoledronic Acid
DrugBank: Zoledronic acid (DB00399)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: If desired, given intravenously every 6 months for a total of 4 injections (optional)
Study: NCT01091168
Drug: Alkylating agent of physician choice registered in cancer
Normalized name: petroleum alkylate
Approvals — FDA: no, EMA: no, PMDA: no
Description: cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin
Study: NCT00199082
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00199082
Drug: Dexamethasone/Prednisolone
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00199082
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01865474
Drug: DLBS1033
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 DLBS1033 tablet 490 mg thrice daily for 2 months
Study: NCT01865474
Drug: placebo tablet of DLBS1033
Normalized name: PLACEBO TAB
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 placebo tablet of DLBS1033 thrice daily for 2 months
Study: NCT03582215
Drug: Part 1: Cream
Approvals — FDA: no, EMA: no, PMDA: no
Description: Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
Study: NCT03582215
Drug: Part 1: Lotion
Approvals — FDA: no, EMA: no, PMDA: no
Description: Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
Study: NCT03582215
Drug: Part 1: Spray 1
Approvals — FDA: no, EMA: no, PMDA: no
Description: Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
Study: NCT03582215
Drug: Part 1: Spray 2
Approvals — FDA: no, EMA: no, PMDA: no
Description: Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
Study: NCT01060410
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: intravenous injection, 0.2g, once every two days
Study: NCT00812461
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: as-needed use, tablets, orally, 6 months
Study: NCT03342079
Drug: Local Anesthetics,(lidocaine 70 mg/tetracaine 70 mg topical patch; Synera)
Approvals — FDA: no, EMA: no, PMDA: no
Description: topical anesthetic (lidocaine 70 mg/tetracaine 70 mg topical patch; Synera)
Study: NCT03342079
Drug: Placebos
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo topical anesthetic
Study: NCT00041119
Drug: AC regimen
Normalized name: Anacin Aspirin Regimen Pill
Approvals — FDA: no, EMA: no, PMDA: no
Description: Given IV
Study: NCT00041119
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT00041119
Drug: doxorubicin hydrochloride
Normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV
Study: NCT03582215
Drug: Part 2: Lotion
Approvals — FDA: no, EMA: no, PMDA: no
Description: Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
Study: NCT03582215
Drug: Part 2: Aerosol Spray
Approvals — FDA: no, EMA: no, PMDA: no
Description: Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
Study: NCT03582215
Drug: Part 2: Nonaerosol Spray
Approvals — FDA: no, EMA: no, PMDA: no
Description: Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
Study: NCT03582215
Drug: Part 2: Pump Spray
Approvals — FDA: no, EMA: no, PMDA: no
Description: Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
Study: NCT02163902
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events
Study: NCT00992706
Drug: antiperspirant cream F511
Normalized name: DEODORANTS/ANTIPERSPIRANTS,TOPICAL
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo and verum cream once daily, in the morning, during the first week of the first PLD treatment only, then once daily, three times per week (in the morning). Tube R for right hand and foot, tube L for left hand and foot.
Study: NCT03954639
Drug: EXPAREL 13.3Mg/mL Suspension for Injection
Normalized name: EXPAREL 13.3mg/mL Suspension for Injection
Approvals — FDA: no, EMA: no, PMDA: no
Description: Combined Sciatic and Adductor Canal Nerve Block with EXPAREL mixed with Bupivacaine (Single Dose)
Study: NCT01140308
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Randomization to Treatment: Simvastatin 20mg + Placebo 600mg Load Subjects for 2 weeks on Treatment Eight weeks of treatment
Study: NCT04244448
Drug: receive dissolved form of BIKTARVY®
Approvals — FDA: no, EMA: no, PMDA: no
Description: The healthy volunteers will receive dissolved form of BIKTARVY® Pharmacokinetic samples will be taken at the following times: 0 hour (right before taking Biktarvy®); 0.5 hour; 1 hour; 1.5 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 8 hours; 12 hours; 24 hours; 36 hours; 48 hours and 72 hours (after Biktarvy®).
Study: NCT04244448
Drug: receive crushed form of BIKTARVY®
Approvals — FDA: no, EMA: no, PMDA: no
Description: The healthy volunteers will receive crushed form of BIKTARVY® Pharmacokinetic samples will be taken at the following times: 0 hour (right before taking Biktarvy®); 0.5 hour; 1 hour; 1.5 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 8 hours; 12 hours; 24 hours; 36 hours; 48 hours and 72 hours (after Biktarvy®).
Study: NCT04244448
Drug: receive solid form of BIKTARVY®
Approvals — FDA: no, EMA: no, PMDA: no
Description: The healthy volunteers will receive solid form of BIKTARVY® Pharmacokinetic samples will be taken at the following times: 0 hour (right before taking Biktarvy®); 0.5 hour; 1 hour; 1.5 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 8 hours; 12 hours; 24 hours; 36 hours; 48 hours and 72 hours (after Biktarvy®).
Study: NCT00992706
Drug: pegylated liposomal doxorubicin hydrochloride
Approvals — FDA: no, EMA: no, PMDA: no
Description: According to local practice. 1, 2 and 4 week schedules with at least 10mg/m2 per week are allowed.
Study: NCT02511665
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Given placebo
Study: NCT01542632
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo subcutaneous injection
Study: NCT01542632
Drug: New Formulation Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: New Formulation placebo subcutaneous injection
Study: NCT01496976
Drug: High Dose Methylprednisolone (HDMP)
Normalized name: Methylprednisolone
DrugBank: Methylprednisolone (DB00959)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: HDMP will be administered at 1 gm/m\^2 IV over 90 minutes daily with ofatumumab infusions 1-8.
Study: NCT00777582
Drug: AZD2281
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral single dose formulation
Study: NCT04352686
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administration of placebo to assess differences in esophageal sensitivity
Study: NCT04494256
Drug: BIIB105
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered as specified in the treatment arm.
Study: NCT04494256
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered as specified in the treatment arm.
Study: NCT01033240
Drug: CS-1008 2 mg/kg
Approvals — FDA: no, EMA: no, PMDA: no
Description: On a once a week basis CS-1008 will be administered intravenously starting at 2 mg/kg.
Study: NCT01033240
Drug: CS-1008 6/2 mg/kg
Approvals — FDA: no, EMA: no, PMDA: no
Description: A 6 mg/kg loading dose of CS-1008 will be administered intravenously, followed by a 2 mg/kg/week maintenance dose on a once-a-week basis.
Study: NCT01033240
Drug: CS-1008 6/6 mg/kg
Approvals — FDA: no, EMA: no, PMDA: no
Description: A 6 mg/kg loading dose of CS-1008 will be administered intravenously, followed by a 6 mg/kg/week maintenance dose on a once-a-week basis.
Study: NCT01033240
Drug: CS-1008 4 mg/kg
Approvals — FDA: no, EMA: no, PMDA: no
Description: On a once a week basis CS-1008 will be administered intravenously at 4 mg/kg if tolerated.
Study: NCT01033240
Drug: CS-1008 6 mg/kg
Approvals — FDA: no, EMA: no, PMDA: no
Description: On a once a week basis CS-1008 will be administered intravenously at 6 mg/kg if tolerated.
Study: NCT04332822
Drug: R-pola-mini-CHP
Normalized name: pantolactone, (R)-
Approvals — FDA: no, EMA: no, PMDA: no
Description: * Rituximab 375 mg/m2 iv, day 1, cycle 1. 1400 mg s c OR 375 mg/m2 iv cycles 2-6~* Cyclophosphamide 400 mg/m2 iv, day 1, cycles 1-6~* Doxorubicin 25 mg/m2 iv , day 1, cycles 1-6~* Prednisone, 40 mg/m2 po, days 1-5, cycles 1-6 - round up to nearest 25 mg~* Polatuzumab vedotin 1.8 mg/kg iv day 1 cycles 1-6
Study: NCT04332822
Drug: R-mini-CHOP
Normalized name: pantolactone, (R)-
Approvals — FDA: no, EMA: no, PMDA: no
Description: * Rituximab 375 mg/m2 i.v., day 1, cycle 1. 1400 mg s c OR 375 mg/m2 i. v. cycles 2-6~* Cyclophosphamide 400 mg/m2 i.v., day 1, cycles 1-6~* Doxorubicin 25 mg/m2 i.v., day 1, cycles 1-6~* Vincristine 1 mg i.v. (total dose), day 1, cycles 1-6~* Prednisone, 40 mg/m2 p.o, days 1-5, , cycles 1-6
Study: NCT04295317
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Capecitabine 2500mg / m2/ d, 2 times/d for 2 weeks, followed by 1 week of stopping ,Three weeks is a course of treatment with a total of 8 courses, or the patient has tumor recurrence or metastasis (requires imaging to determine tumor recurrence or metastasis)
Study: NCT01035216
Drug: GNKG168
Approvals — FDA: no, EMA: no, PMDA: no
Description: GNKG168 will be administered as a 60 minute IV infusion once daily for 5 days followed by a 9 day rest period.
Study: NCT04145349
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Administered orally
Study: NCT03838185
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single oral dose of corn oil
Study: NCT01815723
Drug: FP187 placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: FP187 matching placebo tablets in the same regimen as for FP187 arm
Study: NCT01815723
Drug: Fumaderm® placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Fumaderm® matching placebo tablets in the same regimen as for Fumaderm® arm
Study: NCT01904760
Drug: Saline placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day
Study: NCT01032057
Drug: capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT03495960
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: During the primary chemo-immunotherapy (PRIMAIN regimen, 2 courses; every 43 days) administered as induction in the PART A of the study, Methotrexate is given 3 g/m2 as infusion (0.5 g/m2 in 15 min. + 2.5 g/m2 in 3-hr infusion) on days 2, 16 \& 30
Study: NCT01894685
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo 3 grams, once daily for six months
Study: NCT00869063
Drug: Diclofenac Sodium Patch
Normalized name: diclofenac sodium Medicated Patch
Approvals — FDA: no, EMA: no, PMDA: no
Description: Topical 1% diclofenac sodium patch, applied once daily for 7 days
Study: NCT00869063
Drug: Matching Placebo Patch
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching placebo patch, containing identical constituents to the active drug arm except for diclofenac sodium; applied once daily for 7 days
Study: NCT03568422
Drug: CFI-402257
Approvals — FDA: no, EMA: no, PMDA: no
Description: Orally taken on intermittent schedule (days 1, 2, 8, 9, 15 \& 16
Study: NCT01096966
Drug: Placebo patch
Approvals — FDA: no, EMA: no, PMDA: no
Description: Identical in size and shape to the Bupivacaine Patch. Three patches applied to the lower back every 72 hours for 12 weeks.
Study: NCT02631603
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administer Placebo as anti-inflammatory
Study: NCT02631603
Drug: Prednisolone
Normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Administer Prednisolone as anti-inflammatory
Study: NCT00002643
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00002643
Drug: doxorubicin hydrochloride
Normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02995018
Drug: BAY987521
Approvals — FDA: no, EMA: no, PMDA: no
Description: Each 50 cm\*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm\*2 test application. (Formulation Code: Z09-174)
Study: NCT02995018
Drug: SPF Control
Approvals — FDA: no, EMA: no, PMDA: no
Description: Each 50 cm\*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm\*2 test application.
Study: NCT04219826
Drug: Placebo for CK-3773274
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo administered orally
Study: NCT01143298
Drug: LEO 27847 oral solution
Normalized name: ethanol
DrugBank: Ethanol (DB00898)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00688896
Drug: JTT-705 600 mg and pravastatin 40 mg
Normalized name: pravastatin and ezetimibe
Approvals — FDA: no, EMA: no, PMDA: no
Description: * JTT-705 300 mg tablets, 600 mg dose, 2 tablets, oral, once daily, immediately following breakfast and/or assessment~* Pravastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, at bedtime
Study: NCT00688896
Drug: JTT-705 300 mg and pravastatin 40 mg
Normalized name: pravastatin and ezetimibe
Approvals — FDA: no, EMA: no, PMDA: no
Description: * JTT-705 300 mg tablets, 300 mg dose, 1 tablet, oral, once daily, immediately following breakfast and/or assessment~* Placebo tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments~* Pravastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, at bedtime
Study: NCT00688896
Drug: Placebo and pravastatin 40 mg
Normalized name: pravastatin and ezetimibe
Approvals — FDA: no, EMA: no, PMDA: no
Description: * Placebo tablets, 2 tablets, oral, once daily, immediately following breakfast and/or assessments~* Pravastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, at bedtime
Study: NCT05288816
Drug: ALXN1210
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants received a single dose (400 mg or 800 mg) and multiple doses (800 mg) of ALXN1210.
Study: NCT00868634
Drug: capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 1000 mg/m2 twice daily, oral, days 1-14. Cycles are repeated every three weeks.
Study: NCT02135848
Drug: GSK1278863
Approvals — FDA: no, EMA: no, PMDA: no
Description: GSK1278863
Study: NCT02135848
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT03977363
Drug: Anticoagulant drugs
Normalized name: CPDA-1 Anticoagulant
Approvals — FDA: no, EMA: no, PMDA: no
Description: Anticoagulant drugs
Study: NCT03602612
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3
Study: NCT03143153
Drug: Fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Specified dose on specified days
Study: NCT01323582
Drug: Erythromycin
Normalized name: Erythromycin
DrugBank: Erythromycin (DB00199)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 200mg/5ml elixir administered orally three times a day half an hour prior to meals.
Study: NCT01323582
Drug: Azithromycin
Normalized name: Azithromycin
DrugBank: Azithromycin (DB00207)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: The dose of Azithromycin given was determined based on the following study on 10 healthy subjects. In random order, each of ten healthy subjects underwent OBT studies following administration of AZI, at doses of 50mg, 100mg, and 133mg. The T½ and Tlag was then compared for the three doses by a randomized block analysis using Analysis of Variance followed by Tukey's multiple comparison. Results: The T½ for each of the respective doses of AZI (50mg, 100mg, and 133mg) was 129 ± 27, 128 ± 31, and 128 ± 16 minutes (p = 0.98). This data suggested that AZI at doses of 50mg, 100mg and 133 mg have fairly similar activity in its effects on gastric emptying in healthy subjects. Based on this analysis , we decided to use a dose of 50 mg/5 ml for administered TID prior to meals.
Study: NCT01828177
Drug: PDI-320
Normalized name: ethanol
DrugBank: Ethanol (DB00898)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT01828177
Drug: PDI-320 Monad #1
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01828177
Drug: PDI-320 Monad #2
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01828177
Drug: Vehicle
Normalized name: Drug vehicle
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02848820
Drug: Augmentin + Gentamicin
Approvals — FDA: no, EMA: no, PMDA: no
Description: Amoxicillin/clavulanic acid (Augmentin) 25/2.5mg 6-hourly (total 100/10 mg/kg daily; maximum 6000/600mg a day) intravenously for 48 hours Oral amoxicillin/clavulanic acid 50/12.5 mg/kg 8-hourly (max 1500/375mg a day) for in total 7 days Gentamicin 7mg/kg once daily for 48 hours
Study: NCT04043455
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Olorinab matching placebo capsule or tablet by mouth, 3 times per day up to 12 weeks
Study: NCT00591006
Drug: Phenytoin (brand name Dilantin)
Normalized name: Phenytoin
DrugBank: Phenytoin (DB00252)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Three days prior to imaging, participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total).