AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT00797966
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tablets, Oral, 1- 4 mg OPC-34712 once daily, 14 weeks
Trial: NCT00301925
Drug: fluorouracil
RxNorm normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00301925
Drug: methotrexate
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00797966
Drug: ADT
RxNorm normalized name: Radtue
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tablets, 10 - 225 mgs, dose once daily, 14 weeks
Trial: NCT00740948
Drug: Placebo: NaCl 0.9% or Glucose 5%
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2\* 250ml of NaCl 0.9% or Glucose 5% at the 1st day and at the 14th day.
Trial: NCT01121224
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.
Trial: NCT03022799
Drug: KM-819
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03022799
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04035005
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: 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.
Trial: NCT01242813
Drug: ACZ885
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03180619
Drug: TAF
RxNorm normalized name: Altafed
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tablet administered orally once daily
Trial: NCT01929941
Drug: INCB047986
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Initial cohort dose of INCB047986 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria
Trial: NCT01929941
Drug: INCB047986
FDA approved: no
EMA approved: no
PMDA approved: no
Description: INCB047986 tablets administered orally at the protocol specified dose and frequency
Trial: NCT02128685
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00359073
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: like placebo
Trial: NCT00375401
Drug: CP-945,598 Treatment A
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Arm includes CP-945,598 Treatment A plus Dietary, Physical Activity, and Weight Loss Counseling
Trial: NCT00375401
Drug: CP-945,598 Treatment B
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Arm includes CP-945,598 Treatment B plus Dietary, Physical Activity, and Weight Loss Counseling
Trial: NCT00375401
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Arm includes Placebo plus Dietary, Physical Activity, and Weight Loss Counseling
Trial: NCT00600119
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo, oral, once daily (QD)
Trial: NCT00600119
Drug: NKTR-118
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)
Trial: NCT01246102
Drug: AT13387
FDA approved: no
EMA approved: no
PMDA approved: 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.
Trial: NCT04243655
Drug: Standard medical treatment (SMT)
FDA approved: no
EMA approved: no
PMDA approved: 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.
Trial: NCT00729469
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: 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
Trial: NCT03015207
Drug: NNC0194-0499
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03015207
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01302145
Drug: ASP1941
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tablet
Trial: NCT01302145
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tablet
Trial: NCT03711240
Drug: Leucovorin
RxNorm normalized name: Leucovorin
DrugBank: Leucovorin (DB00650)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 200mg/m2 2-hour iv infusion, day 1 every 2 weeks
Trial: NCT02845037
Drug: BIA 5-453
RxNorm normalized name: Oatmeal 10 mg in 1 mL TOPICAL CREAM [BIA Eczema Relief]
FDA approved: no
EMA approved: no
PMDA approved: 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.
Trial: NCT02845037
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: 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).
Trial: NCT02414165
Drug: Toca FC
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Toca FC is an extended-release formulation of flucytosine and is supplied as 500 mg tablets
Trial: NCT02284425
Drug: REGN1193
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02284425
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01317069
Drug: Fluorouracil implant
RxNorm normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: 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
Trial: NCT00393510
Drug: TCM
RxNorm normalized name: ALCOHOL 0.7 mL in 1 mL TOPICAL GEL [TCM Brand Hand Sanitizer]
FDA approved: no
EMA approved: no
PMDA approved: 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
Trial: NCT00393510
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: 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.
Trial: NCT02872220
Drug: SPF 50 Y65 110 (BAY987519)
FDA approved: no
EMA approved: no
PMDA approved: 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.
Trial: NCT02872220
Drug: SPF 50 Y51 002 (BAY987519)
FDA approved: no
EMA approved: no
PMDA approved: 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.
Trial: NCT02872220
Drug: SPF 15 V27 104 (BAY987519)
FDA approved: no
EMA approved: no
PMDA approved: 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.
Trial: NCT02973880
Drug: NETILDEX™ ophthalmic gel
FDA approved: no
EMA approved: no
PMDA approved: 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.
Trial: NCT02973880
Drug: NETILDEX™ eye drops solution
FDA approved: no
EMA approved: no
PMDA approved: 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.
Trial: NCT01332461
Drug: Other maintenance Treatments (OMT)
RxNorm normalized name: Dental Resources Perio Maintenance Rinse
FDA approved: no
EMA approved: no
PMDA approved: no
Description: OMT group includes tiotropium, ipratropium alone or in combination with albuterol, inhaled steroids, long acting beta agonists
Trial: NCT00548184
Drug: Endocrine
RxNorm normalized name: ENDOCRINE THERAPY
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Hormonal Therapy
Trial: NCT01423188
Drug: RVX000222
FDA approved: no
EMA approved: no
PMDA approved: no
Description: capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 24 weeks
Trial: NCT01423188
Drug: Placebo RVX000222
FDA approved: no
EMA approved: no
PMDA approved: no
Description: capsule, administer with food, twice daily 10-12 hrs apart, 24 weeks
Trial: NCT01205867
Drug: AZD8848
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Nasal spray solution, intranasal, single ascending doses, 1.4 - 60 μg
Trial: NCT03692819
Drug: Placebo Oral Tablet
RxNorm normalized name: placebo ORAL TABLET
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Non-surgical periodontal treatment will be performed by means of periodontal debridement in a single session.
Trial: NCT02410343
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo treatment was administered in a blinded fashion and titrated on weeks 4, 8, 12 and 16 to mimic the active treatment.
Trial: NCT02379689
Drug: Injectable placental tissue extract called BioDGenesis (Active Product)
RxNorm normalized name: human placental tissue preparation
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02379689
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04408560
Drug: Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Rhus toxicodendron 9 CH + Ruta graveolens 5 CH
Trial: NCT02206100
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Reversal of edoxaban-induced anticoagulation
Trial: NCT00920803
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: 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.
Trial: NCT00920803
Drug: SRT501
FDA approved: no
EMA approved: no
PMDA approved: 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.
Trial: NCT01433380
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: One single dose of placebo will be administered as a powder-in-capsule in the fasting state in the AM.
Trial: NCT02319629
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01510769
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tablets, Placebo QD
Trial: NCT02674204
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A substance that has no therapeutic effect, and will be used as a control in testing the study agent.
Trial: NCT02269540
Drug: Existing depression medication treatment
RxNorm normalized name: zinc pyrithione Medicated Shampoo [Head & Shoulders Damage Treatment]
FDA approved: no
EMA approved: no
PMDA approved: 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
Trial: NCT04040322
Drug: Placebo IV infusion
FDA approved: no
EMA approved: no
PMDA approved: 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.
Trial: NCT02747472
Drug: GIP(1-42)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: GIP receptor agonist
Trial: NCT00574236
Drug: PS-341, doxorubicin
FDA approved: no
EMA approved: no
PMDA approved: 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
Trial: NCT02886494
Drug: BAC treatment
RxNorm normalized name: Anti Bac
FDA approved: no
EMA approved: no
PMDA approved: no
Description: BAC, topical application on external nasal skin, scalp, and neck, 2 times daily, 30 g/day for 12 weeks
Trial: NCT02277548
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02067975
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03370705
Drug: Statin
RxNorm normalized name: Statin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Statin 20mg once daily per oral route,
Trial: NCT03370705
Drug: Antiplatelet Agents
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Antiplatelet therapy 75mg once daily per oral route
Trial: NCT03370705
Drug: ACE inhibitor
RxNorm normalized name: ACE INHIBITORS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ACE inhibitor 20mg once daily per oral route
Trial: NCT02172534
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02956590
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT00486811
Drug: Matching Placebo (twice daily)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching Placebo during 15 weeks (3 weeks titration and 12 weeks maintenance)
Trial: NCT04270279
Drug: Xueshuanxinmaining tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A kind of Chinese patent medicine
Trial: NCT04270279
Drug: Xueshuanxinmaining placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The simulant of Xueshuanxinmaining tablet
Trial: NCT00678756
Drug: Ketokonazol 2% cream
FDA approved: no
EMA approved: no
PMDA approved: no
Description: twice a day at 2 times,2 out of 5 areas have to be treated for 4 weeks/7 days a week
Trial: NCT03248349
Drug: Pharmacokinetics
FDA approved: no
EMA approved: no
PMDA approved: 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
Trial: NCT00536393
Drug: Doxorubicin
RxNorm normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00536393
Drug: Doxorubicin pegylated
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: 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.
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00185198
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: 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
Trial: NCT00024557
Drug: IL13-PE38QQR
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT05605938
Drug: Tenoten for children
RxNorm normalized name: Pediaclear Childrens
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral administration
Trial: NCT05605938
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral administration
Trial: NCT00827138
Drug: DCC-2036
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 150 mg BID tablets, continuous dosing of 28 day cycles
Trial: NCT02230332
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00895102
Drug: ABT-333 Tablet
RxNorm normalized name: ABT-925
FDA approved: no
EMA approved: no
PMDA approved: no
Description: See Arm Description for more information.
Trial: NCT00895102
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: See Arm Description for more information.
Trial: NCT00895102
Drug: ABT-333 Capsule
RxNorm normalized name: ABT-925
FDA approved: no
EMA approved: no
PMDA approved: no
Description: See arm description for more information
Trial: NCT01185353
Drug: LY3009104
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered orally
Trial: NCT01185353
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered orally
Trial: NCT00004123
Drug: Doxorubicin hydrochloride (DOX)
RxNorm normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: 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.
Trial: NCT01185353
Drug: Methotrexate
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Administered orally as background therapy
Trial: NCT00266786
Drug: Intranasal Ketorolac Tromethamine
RxNorm normalized name: Ketorolac Tromethamine
DrugBank: Ketorolac (DB00465)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Intranasal at 30mg
Trial: NCT00266786
Drug: Intranasal Placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intranasal Placebo
Trial: NCT00627575
Drug: phenytoin
RxNorm normalized name: Phenytoin
DrugBank: Phenytoin (DB00252)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Phenytoin will available as 100 mg capsules.
Trial: NCT04066712
Drug: LC350189 200 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7
Trial: NCT01375075
Drug: LY2484595
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered orally
Trial: NCT01375075
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered orally
Trial: NCT04060979
Drug: Nitric Oxide
RxNorm normalized name: Nitric Oxide
DrugBank: Nitric Oxide (DB00435)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Nitric Oxide given intermittently via inhalation
Trial: NCT00473980
Drug: Indomethacin, celecoxib, esomeprazole
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01626209
Drug: BKM120
FDA approved: no
EMA approved: no
PMDA approved: 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).
Trial: NCT00259311
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01257737
Drug: HPN-100
FDA approved: no
EMA approved: no
PMDA approved: 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.
Trial: NCT01181986
Drug: Placebo SC
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo sc BID/10days
Trial: NCT01181986
Drug: Placebo IV
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intravenous infusion for 45 minutes on 1 out of 3 visits
Trial: NCT04064125
Drug: FMX-101
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00392145
Drug: Standard IV rehydration
FDA approved: no
EMA approved: no
PMDA approved: 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).
Trial: NCT03255083
Drug: DS-1205c
RxNorm normalized name: Uretron DS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: DS-1205c 200 mg capsule
Trial: NCT01303224
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral tablet, (identical in appearance and weight to Ibodutant tablets), once daily, for 8 weeks
Trial: NCT00648050
Drug: Verelan® PM Extended-Release Capsules, 300 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 300mg, single dose fasting
Trial: NCT04468529
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 10 hours per day i.v. drip for the first 10 days (0ug/kg/day)
Trial: NCT00956098
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no