AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT01215851
Drug: TMC207
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14
Trial: NCT01215851
Drug: Rifafour
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Rifafour e-275
Trial: NCT02951780
Drug: LY3185643
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered SC
Trial: NCT06098326
Drug: cyclophosphamide, fludarabine, and antithymocyte globulin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1. Cyclophosphamide 50 mg/kg/day i.v. daily on days -3 and -2 (for 2 days)~2. Fludarabine 30 mg/m2/day i.v. daily on days -7to -2 (for 6 days)~3. Antithymocyte globulin (Thymoglobulin) 1.5 mg/kg/day (for HLA-matched sibling donor HCT) or 3.0 mg/kg/day (for other alternative donor HCT) i.v. daily on days -3 to -1 (for 3 days)
Trial: NCT03576235
Drug: PG102P
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Daily dose of 1.5g
Trial: NCT03576235
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Daily dose of placebo
Trial: NCT00790673
Drug: CF 102
RxNorm normalized name: californium Cf-249
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral capsules
Trial: NCT00790673
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo capsules
Trial: NCT04561856
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Normal Saline 2ml
Trial: NCT03700177
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: modified pectoralis block for breast surgery with ropivacaine combined with placebo (NaCl 0,9%).
Trial: NCT04349683
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 6 capsules at a time, 3 times a day (tid).
Trial: NCT02669589
Drug: Heparin
RxNorm normalized name: Heparin
DrugBank: Heparin (DB01109)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01302925
Drug: PEP005 Gel
FDA approved: no
EMA approved: no
PMDA approved: no
Description: PEP005 Gel 0.05% for 2 consecutive days
Trial: NCT01302925
Drug: PEP005 Gel
FDA approved: no
EMA approved: no
PMDA approved: no
Description: PEP005 Gel 0.015% for 3 consecutive days
Trial: NCT02297412
Drug: Minocycline Hydrochloride
RxNorm normalized name: Minocycline Hydrochloride
DrugBank: Minocycline (DB01017)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given PO
Trial: NCT04826198
Drug: AsiDNA
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Unit dose: Vial containing 100 mg of AsiDNA™ (free acid) Regimen: 3 consecutive infusions (D1, D2, D3) followed by a once a week iv infusion on D8 and D15 of a 21 day-treatment cycle at first cycle, then weekly iv infusion in the absence of disease progression or unacceptable toxicity Mode/route: 1 hour intravenous (iv) infusion
Trial: NCT02136784
Drug: hydrocodone
RxNorm normalized name: Hydrocodone
DrugBank: Hydrocodone (DB00956)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.
Trial: NCT02136784
Drug: oral tablet placebo
RxNorm normalized name: placebo Oral Tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.
Trial: NCT02136784
Drug: sublingual tablet placebo
RxNorm normalized name: placebo Oral Tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.
Trial: NCT02794571
Drug: Capecitabine
RxNorm normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Capecitabine 1250 mg/m\^2 oral dose will be administered twice daily (BID) on Days 1 through 14 of each 21-day cycle. On Day 1 of Cycle 1, the first dose of capecitabine will be administered prior to the atezolizumab and tiragolumab infusion.
Trial: NCT01347060
Drug: inhaled corticosteroids
RxNorm normalized name: CORTICOSTEROIDS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Inhaled corticosteroids: beclomethasone dipropionte, mometasone, fluticasone propionate, budesonide, and flunisolide
Trial: NCT02945033
Drug: placebo intake
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patient with colonic adenocarcinoma stage III or II high risk will take placebo of aspirin 100 mg/day during 3 years
Trial: NCT04570384
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients randomized to placebo will receive equal volume bolus and study infusion of 5% dextrose water for a maximum of 10 days.
Trial: NCT03518021
Drug: placebo, intranasal
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Same spray but without naloxone. Nasal spray will be administered with one puff (100 microL +/- 10%) in one nostril using the Aptar Unitdose device.~The spray device should be inserted about 1 cm into a nostril, pointing towards the ipsilateral ear and the plunger pushed in a firm and gentle manner for the formulation to be sprayed into the nose. After the plunger is inserted the device is immediately removed from the nose and assisted ventilation continued.
Trial: NCT03518021
Drug: placebo, intramuscular
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intramuscular Sodium Chloride Injection 9mg/ml, will be administered as a 2 ml intramuscular injection in the deltoid muscle
Trial: NCT01278485
Drug: Sulphonylurea
RxNorm normalized name: metformin and sulfonylureas
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SU administered according to usual practice.
Trial: NCT01278485
Drug: Metformn
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Metformin administered according to usual practice.
Trial: NCT02886299
Drug: Simvastatin
RxNorm normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT03531736
Drug: cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: cyclophosphamide given post stem cell infusion (50 mg/kg on days +3 and +4)
Trial: NCT01394679
Drug: (99m Tc) ECDG (Ethylenedicysteine-Deoxyglucose)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: One injection of Technetium-99m Ethylenedicysteine-Deoxyglucose to yield a target dose of 25 mCi (range of 20-30 mCi)by IV push and less than 1 mg of EC-DG
Trial: NCT01888861
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: the patients in this arm were received 900mg placebo through NG tube.
Trial: NCT03779438
Drug: 17-OHPC
FDA approved: no
EMA approved: no
PMDA approved: no
Description: patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery
Trial: NCT01394679
Drug: 18 F FDG followed by PET/CT imaging
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single injection of 18 F FDG range of 10-20 mCi
Trial: NCT03198871
Drug: Acetaminophen Injectable Product
RxNorm normalized name: acetaminophen Injectable Product
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
Trial: NCT01031888
Drug: Conventional postoperative eye drops
FDA approved: no
EMA approved: no
PMDA approved: no
Description: topical steroid, antibiotic and mydriatics
Trial: NCT01826487
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo will be administered as per the schedule specified in the arm.
Trial: NCT00984503
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intradermal injection of Placebo at 100μl/cm2 of SSG donor site (3cm2) once just prior to wounding
Trial: NCT00984503
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intradermal placebo at 100μl/cm2 of SSG donor site once just prior to wounding, followed by topical placebo at 200μl/cm2 after wounding and again at Day 1
Trial: NCT01254448
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Group 1: matching placebo administered once daily for 28 days. Group 2: matching placebo administered once daily for 10 days.
Trial: NCT01387347
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
Trial: NCT01428466
Drug: GSK2585823
FDA approved: no
EMA approved: no
PMDA approved: no
Description: CLDM1%/BPO3%
Trial: NCT02559648
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will be randomly assigned, in a 1:1 fashion, to the two therapeutic arms (Group A, Group B, respectively), upon enrollment in the study.~The effect of denosumab on lumbar spine BMD (bone mineral density) in patients with Thalassemia Major and Osteoporosis as compared with control at 12 months will be evaluated.
Trial: NCT01657370
Drug: MK-1602
RxNorm normalized name: vitamin MK 7
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Three administrations of the same dose of MK-1602 on separate days. All 3 doses are either 1, 10, 25, 50 or 100 mg of MK-1602. Dose 1: Taken at onset of migraine of moderate or severe intensity. Dose 2: Taken the evening before Visit 2. Dose 3: Taken at Visit 2, which is Day 4 post migraine treatment (Dose 1).~Dosage form is film coated tablet for oral administration.
Trial: NCT01657370
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Three administrations of placebo for MK-1602 on separate days. Dose 1: Taken at onset of migraine of moderate or severe intensity. Dose 2: Taken the evening before Visit 2. Dose 3: Taken at Visit 2, which is Day 4 post migraine treatment (Dose 1).~Dosage form is film coated tablet for oral administration.
Trial: NCT01657370
Drug: Rescue medication
RxNorm normalized name: ALLERGENIC EXTRACT, MEADOW FESCUE POLLEN
FDA approved: no
EMA approved: no
PMDA approved: no
Description: If moderate or severe migraine headache pain continues 2 hours after dose of study medication or if migraine headache comes back within 48 hours,~Participants will be allowed to take their own rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs \[NSAIDs\]), anti-emetics, triptans, opiates or other medication not explicitly excluded.
Trial: NCT04319757
Drug: ACE1702
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ACE1702 cellular therapy (anti-HER2 oNK cells) given intravenously
Trial: NCT04319757
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Lympho-conditioning agent
Trial: NCT03875638
Drug: Placebo oral capsule
RxNorm normalized name: Placebo Oral Capsule
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The placebo is a capsule that is identical in appearance to the levetiracetam
Trial: NCT01068184
Drug: AZD6553
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single or multiple oral dose
Trial: NCT01068184
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: single or multiple oral dose
Trial: NCT03893526
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo day
Trial: NCT04209556
Drug: PF-06826647 100 mg QD
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Investigational Product
Trial: NCT04209556
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matched Placebo
Trial: NCT04209556
Drug: PF-6826647 400 mg QD
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Investigational Product
Trial: NCT01301677
Drug: Hydrocortisone
RxNorm normalized name: Hydrocortisone
DrugBank: Hydrocortisone succinate (DB14545)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Hydrocortisone liquid formulation
Trial: NCT02153112
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo saline solution
Trial: NCT00272792
Drug: Sapropterin Dihydrochloride
RxNorm normalized name: Sapropterin Dihydrochloride
DrugBank: Sapropterin (DB00360)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120-240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
Trial: NCT00272792
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120-240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
Trial: NCT00864149
Drug: Coreg® 12.5 mg Tablets , single dose
FDA approved: no
EMA approved: no
PMDA approved: no
Description: B: Active comparator Subjects received GlaxoSmithKline, USA formulated products under fed conditions
Trial: NCT04375436
Drug: NTRX-07-SDD
FDA approved: no
EMA approved: no
PMDA approved: no
Description: NTRX-07-SDD for oral administration
Trial: NCT03680885
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: PEG with FD\&C Blue No.1 (Brilliant Blue FCF)
Trial: NCT02389244
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: For adults patients and children with BSA ≥1.70 m² : 4 tablets once daily and switch to regorafenib after confirmed progression For children with BSA ≥1.30 and ≤1.69 m² : 3 tablets once daily and switch to regorafenib after confirmed progression
Trial: NCT04603001
Drug: LY3410738
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral LY3410738
Trial: NCT04633330
Drug: AHCC®capsules
FDA approved: no
EMA approved: no
PMDA approved: no
Description: AHCC®capsules, a standardized extract of cultured Lentinula edodes mycelia (ECLM) TID for 6 months after enrolment.
Trial: NCT04633330
Drug: Simulation of AHCC®capsules
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TID for 6 months after enrolment. A compensation of AHCC®is provided to participant from control arm when HR-HPV positive at 6 months after enrolment.
Trial: NCT00525421
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01098747
Drug: Novel Ibuprofen
RxNorm normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Single-dose of novel ibuprofen (equal to 400 mg ibuprofen)
Trial: NCT01098747
Drug: Standard Ibuprofen
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single-dose of standard ibuprofen (400mg)
Trial: NCT01098747
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single-dose of placebo
Trial: NCT02823002
Drug: Buffer
RxNorm normalized name: Buffers
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Sodium Bicarbonate
Trial: NCT03766984
Drug: Diclofenac sodium 25 mg
RxNorm normalized name: diclofenac sodium 25 MG
DrugBank: Diclofenac (DB00586)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Diclofenac sodium 25 mg Tablets (Laboratorios Tecnandina S.A., Ecuador)
Trial: NCT03766984
Drug: Diclofenac sodium 25 mg/Tramadol hydrochloride 25 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Fixed-dose combination tablet containing diclofenac sodium 25 mg and tramadol hydrochloride 25 mg (Laboratorios Tecnandina S.A., Ecuador)
Trial: NCT00216333
Drug: combined fixed dose combination
RxNorm normalized name: combinations
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02829151
Drug: Triple antiplatelet therapy (aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) )
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Combination antiplatelet therapy using aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) after the index angioplasty
Trial: NCT00276419
Drug: Diclofenac
RxNorm normalized name: Diclofenac
DrugBank: Diclofenac (DB00586)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Compounded topical diclofenac cream applied to the skin three times daily for 10 weeks
Trial: NCT00276419
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks
Trial: NCT00144326
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03186638
Drug: Ibuprofen
RxNorm normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given PO
Trial: NCT02563795
Drug: Fentanyl
RxNorm normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: To compare low dose spinal anesthesia with bupivacaine+ fentanyl alone if it can maintain surgical anesthesia during cesarean section in obese and non-obese pregnants
Trial: NCT00945009
Drug: Doxorubicin Hydrochloride
RxNorm normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT04304560
Drug: Placebo oral tablet
RxNorm normalized name: placebo ORAL TABLET
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Similar Placebo oral tablet
Trial: NCT02482311
Drug: AZD 1775
RxNorm normalized name: aspirin / hydrocodone bitartrate Oral Tablet [Azdone]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: AZD1775 will be taken orally approximately every 12 hours over 3 days at the start of week 1 and week 2 of each 21-day cycle (Days 1-3 and 8-10), for a total of 12 doses with each treatment cycle.~AZD1775 should be taken approximately 2 hours before or 2 hours after food.
Trial: NCT01697709
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo capsules
Trial: NCT00022178
Drug: cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT02829151
Drug: Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazol
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Combination antiplatelet therapy using aspirin (100 mg) and cilostazol (200 mg) after the index angioplasty
Trial: NCT00022178
Drug: doxorubicin hydrochloride
RxNorm normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00022178
Drug: fluorouracil
RxNorm normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT03793621
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: single rising oral dose
Trial: NCT00602693
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 50 mg/kg intravenous over 2 hours on Day -6
Trial: NCT02360592
Drug: Interleukin 2
RxNorm normalized name: Recombinant interleukin 2
FDA approved: no
EMA approved: no
PMDA approved: no
Description: In arm 3, Interleukin 2 is used for 12 weeks
Trial: NCT03394482
Drug: Lu AF35700 5 mg clinical formulation
RxNorm normalized name: DuoCare Clinical
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Lu AF35700 tablets 5 mg oral single dose
Trial: NCT03394482
Drug: Lu AF35700 10 mg clinical formulation
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Lu AF35700 tablets 10 mg oral single dose
Trial: NCT03394482
Drug: Lu AF35700 20 mg clinical formulation
RxNorm normalized name: DuoCare Clinical
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Lu AF35700 tablets 20 mg oral single dose
Trial: NCT04817202
Drug: hzVSF-v13 (intravenous, single dose)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dosage form: 50mg / 100mg / 200mg / 400mg / 800mg /1200mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Intravenous Frequency: Dose at Day 1 (single administration)
Trial: NCT04817202
Drug: hzVSF-v13 (subcutaneous, single dose)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dosage form: 100mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Subcutaneous Frequency: Dose at Day 1 (single administration)
Trial: NCT04817202
Drug: hzVSF-v13 (intravenous, multiple dose)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dosage form: 100mg / 400mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Intravenous Frequency: Dose at Day 1, Day 15, Day 29, Day 43, Day 57 (multiple administration)
Trial: NCT04817202
Drug: Placebo (intravenous, single dose)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1 (single administration)
Trial: NCT04817202
Drug: Placebo (subcutaneous, single dose)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dosage form: 0.9% NaCl Solution Route: Subcutaneous Frequency: Dose at Day 1 (single administration)
Trial: NCT04817202
Drug: Placebo (intravenous, multiple dose)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1, Day 15, Day 29, Day 43, Day 57 (multiple administration)
Trial: NCT04093232
Drug: Hymovis
RxNorm normalized name: Hymovis
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All subjects will receive 2 ultrasound guided Hymovis injections and the goal of the study is to correlate responsiveness to subjects unique SF biomarker panel results before the first Hymovis injection and identify potential mechanism of action of those OA patients who receive the greatest benefit.