TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00301925
Drug: capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00301925
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00797966
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tablets, Oral, 1- 4 mg OPC-34712 once daily, 14 weeks
Study: NCT00301925
Drug: fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00301925
Drug: methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00797966
Drug: ADT
Normalized name: Radtue
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tablets, 10 - 225 mgs, dose once daily, 14 weeks
Study: NCT00740948
Drug: Placebo: NaCl 0.9% or Glucose 5%
Approvals — FDA: no, EMA: no, PMDA: no
Description: 2\* 250ml of NaCl 0.9% or Glucose 5% at the 1st day and at the 14th day.
Study: NCT01121224
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.
Study: NCT03022799
Drug: KM-819
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03022799
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04035005
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: The first dose of placebo will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent doses, placebo will be administered as a single 600 mg infusion every 24 weeks, with a minimum interval of 20 or 22 weeks, depending if the previous dose was administered in one or two infusion, should be maintained between each infusion.
Study: NCT01242813
Drug: ACZ885
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03180619
Drug: TAF
Normalized name: Altafed
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tablet administered orally once daily
Study: NCT01929941
Drug: INCB047986
Approvals — FDA: no, EMA: no, PMDA: no
Description: Initial cohort dose of INCB047986 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria
Study: NCT01929941
Drug: INCB047986
Approvals — FDA: no, EMA: no, PMDA: no
Description: INCB047986 tablets administered orally at the protocol specified dose and frequency
Study: NCT02128685
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00359073
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: like placebo
Study: NCT00375401
Drug: CP-945,598 Treatment A
Approvals — FDA: no, EMA: no, PMDA: no
Description: Arm includes CP-945,598 Treatment A plus Dietary, Physical Activity, and Weight Loss Counseling
Study: NCT00375401
Drug: CP-945,598 Treatment B
Approvals — FDA: no, EMA: no, PMDA: no
Description: Arm includes CP-945,598 Treatment B plus Dietary, Physical Activity, and Weight Loss Counseling
Study: NCT00375401
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Arm includes Placebo plus Dietary, Physical Activity, and Weight Loss Counseling
Study: NCT00600119
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo, oral, once daily (QD)
Study: NCT00600119
Drug: NKTR-118
Approvals — FDA: no, EMA: no, PMDA: no
Description: 5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)
Study: NCT01246102
Drug: AT13387
Approvals — FDA: no, EMA: no, PMDA: no
Description: Treatment will be administered as a 1-hour IV infusion on 2 consecutive days of every week for 3 weeks, followed by a 1-week period without drug administration.
Study: NCT04243655
Drug: Standard medical treatment (SMT)
Approvals — FDA: no, EMA: no, PMDA: no
Description: SMT as per patients requirement- Management of cerebral edema/intracranial hypertension: prophylactic antibiotics, administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure, volume replacement and pressor support (noradrenaline, doubutamine, dopamine) as needed, NAC and correction of metabolic parameters.
Study: NCT00729469
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: oral dose of placebo,1 tablet/day, for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed
Study: NCT03015207
Drug: NNC0194-0499
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03015207
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01302145
Drug: ASP1941
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tablet
Study: NCT01302145
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tablet
Study: NCT03711240
Drug: Leucovorin
Normalized name: Leucovorin
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 200mg/m2 2-hour iv infusion, day 1 every 2 weeks
Study: NCT02845037
Drug: BIA 5-453
Normalized name: Oatmeal 10 mg in 1 mL TOPICAL CREAM [BIA Eczema Relief]
Approvals — FDA: no, EMA: no, PMDA: no
Description: BIA 5-453 Gelatine capsule for oral administration (1, 10 or 20 mg). Single oral doses of BIA 4-543 2 mg, 10 mg, 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg and 1200 mg were administered to subjects in fasting conditions.
Study: NCT02845037
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo Gelatine capsule for oral administration. The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient (API).
Study: NCT02414165
Drug: Toca FC
Approvals — FDA: no, EMA: no, PMDA: no
Description: Toca FC is an extended-release formulation of flucytosine and is supplied as 500 mg tablets
Study: NCT02284425
Drug: REGN1193
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02284425
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01317069
Drug: Fluorouracil implant
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Before the abdomen was closed, fluorouracil implant 1000mg was sprayed evenly on the surface of tumor resection area, and some of the drugs were put into mesenteric root based on the location
Study: NCT00393510
Drug: TCM
Normalized name: ALCOHOL 0.7 mL in 1 mL TOPICAL GEL [TCM Brand Hand Sanitizer]
Approvals — FDA: no, EMA: no, PMDA: no
Description: The Decoction is taken orally, twice a day, treatment period is 24 weeks The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients.~The formula consisted of 12 herbs, viz:~Radix astragali, Rhizoma atractylodis marcocephalae, Radix stephaniae tetrandrae, Radix polygoni multiflori, Radix rehmanniae, Radix smilax china, Fructus corni, Rhizoma dioscoreae, Cortex moutan, Rhizoma alismatis, Rhizoma smilacis glabrae, and Fructus schisandrae
Study: NCT00393510
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo taking orally, twice a day, 24 week treatment period The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients.~The placebo was made with starch and colouring materials.
Study: NCT02872220
Drug: SPF 50 Y65 110 (BAY987519)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Application of 200 µL in an occlusive patch of Webril (0.150 ± 0.010 mg) compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
Study: NCT02872220
Drug: SPF 50 Y51 002 (BAY987519)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
Study: NCT02872220
Drug: SPF 15 V27 104 (BAY987519)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
Study: NCT02973880
Drug: NETILDEX™ ophthalmic gel
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 drop of NETILDEX™ (Netilmicin Sulfate 3mg/ml / Dexamethasone Disodium Phosphate 1mg/ml) ophthalmic gel immediately after the surgery then 1 drop twice daily (b.i.d.) from Day 1 until Day 14 after surgery + 1 drop of XANTERGEL™ ophthalmic gel twice daily (b.i.d.) from Day 1 until Day 14 after surgery.~Bromfenac 0.9 mg/ml 1 drop twice daily (b.i.d.) for 3 days before cataract surgery.
Study: NCT02973880
Drug: NETILDEX™ eye drops solution
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 drop of NETILDEX™ (Netilmicin Sulfate 3mg/ml / Dexamethasone Disodium Phosphate 1mg/ml) eye drops solution immediately after the surgery then 1 drop four times a day (q.i.d.) from Day 1 until Day 14 after surgery.~Bromfenac 0.9 mg/ml 1 drop twice daily (b.i.d.) for 3 days before cataract surgery.
Study: NCT01332461
Drug: Other maintenance Treatments (OMT)
Normalized name: Dental Resources Perio Maintenance Rinse
Approvals — FDA: no, EMA: no, PMDA: no
Description: OMT group includes tiotropium, ipratropium alone or in combination with albuterol, inhaled steroids, long acting beta agonists
Study: NCT00548184
Drug: Endocrine
Normalized name: ENDOCRINE THERAPY
Approvals — FDA: no, EMA: no, PMDA: no
Description: Hormonal Therapy
Study: NCT01423188
Drug: RVX000222
Approvals — FDA: no, EMA: no, PMDA: no
Description: capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 24 weeks
Study: NCT01423188
Drug: Placebo RVX000222
Approvals — FDA: no, EMA: no, PMDA: no
Description: capsule, administer with food, twice daily 10-12 hrs apart, 24 weeks
Study: NCT00416039
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo at 0.2 mg/kg and morphine 0.5 mg/kg
Study: NCT01205867
Drug: AZD8848
Approvals — FDA: no, EMA: no, PMDA: no
Description: Nasal spray solution, intranasal, single ascending doses, 1.4 - 60 μg
Study: NCT03692819
Drug: Placebo Oral Tablet
Normalized name: placebo ORAL TABLET
Approvals — FDA: no, EMA: no, PMDA: no
Description: Non-surgical periodontal treatment will be performed by means of periodontal debridement in a single session.
Study: NCT02410343
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo treatment was administered in a blinded fashion and titrated on weeks 4, 8, 12 and 16 to mimic the active treatment.
Study: NCT02379689
Drug: Injectable placental tissue extract called BioDGenesis (Active Product)
Normalized name: human placental tissue preparation
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02379689
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04408560
Drug: Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Rhus toxicodendron 9 CH + Ruta graveolens 5 CH
Study: NCT02206100
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Reversal of edoxaban-induced anticoagulation
Study: NCT00920803
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be supplied in clinical kits as a powder which will be reconstituted with vehicle and water into a liquid suspension. Placebo must be used immediately following mixing. Placebo will be administered orally, once daily for 14 days.
Study: NCT00920803
Drug: SRT501
Approvals — FDA: no, EMA: no, PMDA: no
Description: SRT501 will be supplied in clinical kits as a powder which will be reconstituted with vehicle and water into a liquid suspension. The final drug product must be used immediately following mixing. SRT501 will be administered orally, once daily for 14 days.
Study: NCT01433380
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: One single dose of placebo will be administered as a powder-in-capsule in the fasting state in the AM.
Study: NCT02319629
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01510769
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tablets, Placebo QD
Study: NCT02674204
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.
Study: NCT02269540
Drug: Existing depression medication treatment
Normalized name: zinc pyrithione Medicated Shampoo [Head & Shoulders Damage Treatment]
Approvals — FDA: no, EMA: no, PMDA: no
Description: Continuation of depression medication treatment already taken prior to study enrollment except for drugs with affinity for MAO-A or potentially influencing MAO-A levels, including phenelzine, tranylcypromine, moclobemide, cytomel and lithium
Study: NCT04040322
Drug: Placebo IV infusion
Approvals — FDA: no, EMA: no, PMDA: no
Description: Study drug will be initiated at a starting dose of 0.5 ng/kg/min up to 2.0 ng/kg/min. Subjects will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day via a peripheral line.
Study: NCT02747472
Drug: GIP(1-42)
Approvals — FDA: no, EMA: no, PMDA: no
Description: GIP receptor agonist
Study: NCT00574236
Drug: PS-341, doxorubicin
Approvals — FDA: no, EMA: no, PMDA: no
Description: bortezomib:1.3 mg/m2 IVP over 3-5 sec. days 1, 4, 8, 11 of 21 day cycle doxorubicin: 20 mg/m2 IV over 3-5 min. days 1,8 (one hour after bortezomib) of 21 day cycle
Study: NCT02886494
Drug: BAC treatment
Normalized name: Anti Bac
Approvals — FDA: no, EMA: no, PMDA: no
Description: BAC, topical application on external nasal skin, scalp, and neck, 2 times daily, 30 g/day for 12 weeks
Study: NCT02277548
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02067975
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03370705
Drug: Statin
Normalized name: Statin
Approvals — FDA: no, EMA: no, PMDA: no
Description: Statin 20mg once daily per oral route,
Study: NCT03370705
Drug: Antiplatelet Agents
Approvals — FDA: no, EMA: no, PMDA: no
Description: Antiplatelet therapy 75mg once daily per oral route
Study: NCT03370705
Drug: ACE inhibitor
Normalized name: ACE INHIBITORS
Approvals — FDA: no, EMA: no, PMDA: no
Description: ACE inhibitor 20mg once daily per oral route
Study: NCT02172534
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02956590
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT00486811
Drug: Matching Placebo (twice daily)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching Placebo during 15 weeks (3 weeks titration and 12 weeks maintenance)
Study: NCT04270279
Drug: Xueshuanxinmaining tablet
Approvals — FDA: no, EMA: no, PMDA: no
Description: A kind of Chinese patent medicine
Study: NCT04270279
Drug: Xueshuanxinmaining placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: The simulant of Xueshuanxinmaining tablet
Study: NCT00678756
Drug: Ketokonazol 2% cream
Approvals — FDA: no, EMA: no, PMDA: no
Description: twice a day at 2 times,2 out of 5 areas have to be treated for 4 weeks/7 days a week
Study: NCT03248349
Drug: Pharmacokinetics
Approvals — FDA: no, EMA: no, PMDA: no
Description: * Blood samples are drawn for pharmacokinetic properties of antibiotics during routine care treatment~* Blood samples for relevant covariates of drug disposition (kidney function, liver enzymes, C-reactive protein (CRP), albumin)~* Whole blood is stored for DNA analysis~* Urine is drawn from catheter for more detailed estimation of glomerular filtration rate and drug metabolite analysis
Study: NCT00536393
Drug: Doxorubicin
Normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00536393
Drug: Doxorubicin pegylated
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00321126
Drug: Children in the zinc group received 20 mg of elemental zinc as acetate per day in a twice-daily dose for two weeks.
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00185198
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 5g gel sachet, 5g+2.5g sachet or 2x5g sachets per day applied to the skin of the shoulders, arms or abdomen for 6 months followed by 12 months treatment with testosterone 1% gel as described for arm 1
Study: NCT00024557
Drug: IL13-PE38QQR
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT05605938
Drug: Tenoten for children
Normalized name: Pediaclear Childrens
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral administration
Study: NCT05605938
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral administration
Study: NCT00827138
Drug: DCC-2036
Approvals — FDA: no, EMA: no, PMDA: no
Description: 150 mg BID tablets, continuous dosing of 28 day cycles
Study: NCT02230332
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00895102
Drug: ABT-333 Tablet
Normalized name: ABT-925
Approvals — FDA: no, EMA: no, PMDA: no
Description: See Arm Description for more information.
Study: NCT00895102
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: See Arm Description for more information.
Study: NCT00895102
Drug: ABT-333 Capsule
Normalized name: ABT-925
Approvals — FDA: no, EMA: no, PMDA: no
Description: See arm description for more information
Study: NCT01185353
Drug: LY3009104
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered orally
Study: NCT01185353
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered orally
Study: NCT00004123
Drug: Doxorubicin hydrochloride (DOX)
Normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Doxorubicin IV bolus followed immediately by IV over 4 days every week for 5 weeks concurrently with external beam radiotherapy 5 days a week for 4 weeks.
Study: NCT01185353
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Administered orally as background therapy
Study: NCT00266786
Drug: Intranasal Ketorolac Tromethamine
Normalized name: Ketorolac Tromethamine
DrugBank: Ketorolac (DB00465)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Intranasal at 30mg
Study: NCT00266786
Drug: Intranasal Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intranasal Placebo
Study: NCT00627575
Drug: phenytoin
Normalized name: Phenytoin
DrugBank: Phenytoin (DB00252)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Phenytoin will available as 100 mg capsules.
Study: NCT04066712
Drug: LC350189 200 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7
Study: NCT01375075
Drug: LY2484595
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered orally
Study: NCT01375075
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered orally
Study: NCT04060979
Drug: Nitric Oxide
Normalized name: Nitric Oxide
DrugBank: Nitric Oxide (DB00435)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Nitric Oxide given intermittently via inhalation
Study: NCT00473980
Drug: Indomethacin, celecoxib, esomeprazole
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01626209
Drug: BKM120
Approvals — FDA: no, EMA: no, PMDA: no
Description: This is a single arm study, with a starting dose of BKM120 at 80mg/day. Two dose levels: 80mg/day and 100mg /day will be tested in the dose escalation phase. At least 3 patients will be enrolled at each dose level and at least 6 evaluable patients required to be treated at the recommended Phase II dose(RP2D)/MTD dose. After dose escalation the 80mg/day and the 100mg /day dose levels will be expanded to evaluate up to approximately a total of 15 patients each (if 100mg is determined as the RP2D/MTD).
Study: NCT00259311
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01257737
Drug: HPN-100
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants received individualized doses of HPN-100 orally, three times daily (TID) with meals. The initial dose was the same dose administered at the end of the HPN-100-005SE, HPN-100-007, or HPN-100-012SE studies. Dose adjustments (including frequency adjustments) were permitted as judged clinically appropriate by the investigator based on assessment of ammonia-scavenging needs (e.g., severity of the UCD defect, dietary protein intake, and urinary phenylacetylglutamine \[PAGN\] excretion). The maximum recommended dose of HPN-100 in participants weighing less than 20 kg was 0.53 mL/kg/day (equivalent to 600 mg/kg/day of NaPBA), and was 11.48 mL/m²/day in heavier subjects (equivalent to 13g/m²/day of NaPBA). The maximum HPN-100 dose recommended per protocol was 17.4 mL/day, which is equivalent to 20 g/day of NaPBA.
Study: NCT01181986
Drug: Placebo SC
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo sc BID/10days
Study: NCT01181986
Drug: Placebo IV
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intravenous infusion for 45 minutes on 1 out of 3 visits
Study: NCT04064125
Drug: FMX-101
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00392145
Drug: Standard IV rehydration
Approvals — FDA: no, EMA: no, PMDA: no
Description: A 20 mL/kg 0.9% normal saline bolus (maximum 999 mL) will be administered over 1 hour. This will be followed by D5-0.9% normal saline at a maintenance rate (maximum 55 mL/hr).
Study: NCT03255083
Drug: DS-1205c
Normalized name: Uretron DS
Approvals — FDA: no, EMA: no, PMDA: no
Description: DS-1205c 200 mg capsule
Study: NCT01303224
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral tablet, (identical in appearance and weight to Ibodutant tablets), once daily, for 8 weeks
Study: NCT00648050
Drug: Verelan® PM Extended-Release Capsules, 300 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: 300mg, single dose fasting
Study: NCT04468529
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 10 hours per day i.v. drip for the first 10 days (0ug/kg/day)
Study: NCT00956098
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01949467
Drug: iron fumarate
Normalized name: iron fumarate
DrugBank: Iron (DB01592)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: All patients will receive a tablet of 66mg of iron, in the form of iron fumarate (Fumafer®) with 50 ml water.
Study: NCT01030081
Drug: Nifedipine GITS (Adalat® XL 30
Approvals — FDA: no, EMA: no, PMDA: no
Description: Nifedipine GITS (Adalat® XL 30), controlled released tablet, 30 mg
Study: NCT00125346
Drug: Tobramycin Inhalation Powder
Normalized name: Tobramycin Inhalation Powder
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00220779
Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00220779
Drug: Albumin (Human) 25%, United States Pharmacopeia (USP)
Approvals — FDA: no, EMA: no, PMDA: no