TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02847442
Drug: BIA 9-1067
Normalized name: Oatmeal 10 mg in 1 mL TOPICAL CREAM [BIA Eczema Relief]
Approvals — FDA: no, EMA: no, PMDA: no
Description: Opicapone (BIA 9-1067) 50 mg hard capsules. Oral administration, once daily at bedtime, at least one hour before or after the last daily dose of L-dopa/DDCI.
Study: NCT02847442
Drug: levodopa/dopa decarboxylase inhibitor
Approvals — FDA: no, EMA: no, PMDA: no
Description: OPC enhances the effects of L-dopa. Hence, it may be necessary to reduce the subject's L-dopa/DDCI dose within the first days or weeks of OPC treatment by extending the dosing intervals and/or reducing the amount of L-dopa/DDCI per dose
Study: NCT00003458
Drug: Antineoplaston therapy (Atengenal + Astugenal)
Normalized name: Monistat Simple Therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
Study: NCT01202799
Drug: 2% w/w diclofenac sodium topical gel
Approvals — FDA: no, EMA: no, PMDA: no
Description: 2% w/w diclofenac sodium topical gel
Study: NCT01202799
Drug: 1.5% w/w diclofenac sodium topical solution
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1.5% w/w diclofenac sodium topical solution
Study: NCT01202799
Drug: 75 mg diclofenac sodium delayed release tablet
Normalized name: diclofenac
DrugBank: Diclofenac (DB00586)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 75 mg diclofenac sodium delayed release tablet
Study: NCT04575181
Drug: NNC0268-0965
Approvals — FDA: no, EMA: no, PMDA: no
Description: For subcutaneous (s.c., under the skin) injection once daily for 26 weeks
Study: NCT04575181
Drug: Placebo (NNC0268-0965)
Approvals — FDA: no, EMA: no, PMDA: no
Description: For s.c. injection once daily for 26 weeks
Study: NCT04329572
Drug: Azithromycin Tablets
Normalized name: Azithromycin Tablets
DrugBank: Azithromycin (DB00207)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: All patients included in the study will receive AZT 500 mg per day for 5 days.
Study: NCT00847626
Drug: Azilsartan medoxomil and chlorthalidone
Normalized name: Azilsartan Medoxomil and Chlorthalidone Tablets
Approvals — FDA: no, EMA: no, PMDA: no
Description: Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks
Study: NCT00847626
Drug: Azilsartan medoxomil and chlorthalidone
Normalized name: Azilsartan Medoxomil and Chlorthalidone Tablets
Approvals — FDA: no, EMA: no, PMDA: no
Description: Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks
Study: NCT00847626
Drug: Azilsartan medoxomil and chlorthalidone
Normalized name: Azilsartan Medoxomil and Chlorthalidone Tablets
Approvals — FDA: no, EMA: no, PMDA: no
Description: Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks
Study: NCT00847626
Drug: Azilsartan medoxomil and chlorthalidone
Normalized name: Azilsartan Medoxomil and Chlorthalidone Tablets
Approvals — FDA: no, EMA: no, PMDA: no
Description: Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks
Study: NCT00847626
Drug: Azilsartan medoxomil and chlorthalidone
Normalized name: Azilsartan Medoxomil and Chlorthalidone Tablets
Approvals — FDA: no, EMA: no, PMDA: no
Description: Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks
Study: NCT00847626
Drug: Azilsartan medoxomil and chlorthalidone
Normalized name: Azilsartan Medoxomil and Chlorthalidone Tablets
Approvals — FDA: no, EMA: no, PMDA: no
Description: Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks
Study: NCT00847626
Drug: Chlorthalidone
Normalized name: Chlorthalidone
DrugBank: Chlorthalidone (DB00310)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks
Study: NCT00847626
Drug: Chlorthalidone
Normalized name: Chlorthalidone
DrugBank: Chlorthalidone (DB00310)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks
Study: NCT01644474
Drug: Placebo (for Ezetimibe)
Approvals — FDA: no, EMA: no, PMDA: no
Description: One capsule orally once daily at approximately the same time of the day with or without food..
Study: NCT02023879
Drug: Placebo (for Alirocumab)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Solution for injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre-filled pen).
Study: NCT02023879
Drug: Non-statin LMT
Approvals — FDA: no, EMA: no, PMDA: no
Description: Ezetimibe or Fenofibrate at stable dose as background therapy.
Study: NCT01627262
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 3x1000mg placebo granules per day
Study: NCT00451568
Drug: Desorelle
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 tablet/day in 21 days
Study: NCT03054337
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02610075
Drug: AZD1775
Approvals — FDA: no, EMA: no, PMDA: no
Description: All patients will receive intervention with AZD1775 orally. Patients will continue to receive treatment with AZD1775 until disease progression, intolerable toxicity, or discontinuation criteria are met.
Study: NCT00887770
Drug: AZD5672
Approvals — FDA: no, EMA: no, PMDA: no
Description: 12 x 50mg tablet, oral, single dose
Study: NCT00887770
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 12 x matched to AZD5672 50 mg tablet
Study: NCT00887770
Drug: AZD5672
Approvals — FDA: no, EMA: no, PMDA: no
Description: 3 x 50mg tablet, oral. single dose
Study: NCT00887770
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 x matched to Moxifloxacin capsule
Study: NCT00002838
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT03214770
Drug: TheraCal
Normalized name: TheraCal D2000
Approvals — FDA: no, EMA: no, PMDA: no
Description: Biomaterial used for carious lesions reaching to dentin. Material is applied and after 6 month dentin sample collection and the bacterial count by digital colony counter, Agar diffusion test.
Study: NCT03214770
Drug: light-cured calcium hydroxide
Normalized name: Calcium Hydroxide
Approvals — FDA: no, EMA: no, PMDA: no
Description: Biomaterial used for carious lesions reaching to dentin. Material is applied and after 6 month dentin sample collection and the bacterial count by digital colony counter, Agar diffusion test.
Study: NCT01721733
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01721733
Drug: EPI-743 15 mg/kg
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01721733
Drug: EPI-743 5 mg/kg
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03052660
Drug: Placebo oral capsule
Normalized name: Placebo Oral Capsule
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral administration preoperatively
Study: NCT03498703
Drug: Azathioprine Pill
Normalized name: azathioprine Pill
Approvals — FDA: no, EMA: no, PMDA: no
Description: Azathioprine increase pregnancy rate in cases with recurrent implantaion failure
Study: NCT03498703
Drug: Placebo Oral Tablet
Normalized name: placebo ORAL TABLET
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo tablets
Study: NCT01112436
Drug: periarticular injection of multidrug regimen
Normalized name: Anacin Aspirin Regimen
Approvals — FDA: no, EMA: no, PMDA: no
Description: periarticular injection of combination of ropivacaine 15 mg, epinephrine 0.3mg, cefmetazole 1000mg, ketorolac 30mg, morphine HCL 10 mg
Study: NCT01436747
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 2 micrograms daily, peroral, 24 weeks
Study: NCT05288829
Drug: ALXN1210 SC
Approvals — FDA: no, EMA: no, PMDA: no
Description: All doses of ALXN1210 SC were administered by four 100-milligram (mg) SC injections of 1 milliliter (mL) each in the abdominal area. All four 1-mL injections were administered over a 15-minute period with at least 15 minutes between the end of injection in 1 participant and the start of injection in the next participant.
Study: NCT05288829
Drug: ALXN1210 IV
Approvals — FDA: no, EMA: no, PMDA: no
Description: All doses of ALXN1210 IV were administered by IV infusion, using IV sets with in-line filters, at a maximum rate of 333 mL/hour, excluding interruption for safety or technical reason. There were at least 15 minutes between the end-of-infusion/injection in 1 participant and the start-of infusion/injection in the next participant.
Study: NCT05288829
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: All doses of placebo SC were administered by four 100-mg SC injections of 1 mL each in the abdominal area. All four 1-mL injections were administered over a 15-minute period with at least 15 minutes between the end of injection in 1 participant and the start of injection in the next participant.
Study: NCT03423329
Drug: Placebo for Brufen
Approvals — FDA: no, EMA: no, PMDA: no
Description: Sansovit Syrup
Study: NCT03558958
Drug: P-188 NF
Normalized name: P
Approvals — FDA: no, EMA: no, PMDA: no
Description: Poloxamer administered daily via sc injection at 5 mg/Kg
Study: NCT00818415
Drug: Naproxen sodium ER (BAYH6689)
Normalized name: naproxen Extended Release Oral Tablet
Approvals — FDA: no, EMA: no, PMDA: no
Description: Extented release Naproxen sodium (660mg) administered once a day
Study: NCT00818415
Drug: Commercial Naproxen (Aleve, BAYH6689)
Normalized name: Naproxen
DrugBank: Naproxen (DB00788)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Immediate release Commercial Aleve (220mg) administered in a two ( 440 mg) plus one (220mg) dosing regime, 660 mg daily
Study: NCT00537121
Drug: fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT00537121
Drug: leucovorin calcium
Normalized name: Leucovorin Calcium
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT00905905
Drug: Simvastatin
Normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Simvastatin 40 mg/day during the first 7 days and then 20 mg/day for 3 more weeks until the evaluation of flow-mediated brachial artery dilation
Study: NCT00905905
Drug: Ezetimibe-Simvastatin
Normalized name: ezetimibe-simvastatin
Approvals — FDA: no, EMA: no, PMDA: no
Description: Ezetimibe-Simvastatin 10-40 mg/day during the first 7 days and then 20 mg/day for 3 more weeks until the evaluation of flow-mediated brachial artery dilation
Study: NCT00508989
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 500 mg daily for 4 weeks, 1000 mg daily for 4 weeks, and 1500 mg daily for 4 weeks
Study: NCT00508989
Drug: Acetylcholine
Normalized name: Acetylcholine
DrugBank: Acetylcholine (DB03128)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00472186
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will also be administered based on weight.
Study: NCT00492843
Drug: Ibandronate (Bondronat)
Normalized name: ibandronate
DrugBank: Ibandronate (DB00710)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day.
Study: NCT01594177
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 600 mg/m² i.v. given on day 1 q day 22 for 4 cycles.
Study: NCT03765762
Drug: GRF6019
Approvals — FDA: no, EMA: no, PMDA: no
Description: GRF6019 for IV infusion
Study: NCT00054678
Drug: MyoCell™
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02053883
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Fibrin sealant alone administered extradurally during spinal decompression/stabilization surgery.
Study: NCT02656589
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Capecitabine will be administered orally at a dose of 2500mg/m2 daily for 3 months (Day 1 to 14 of a 21-day cycle)
Study: NCT00458276
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo (i.e., normal saline) for i.v. use.
Study: NCT00980746
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: oral route
Study: NCT02432833
Drug: ENVARSUS®
Approvals — FDA: no, EMA: no, PMDA: no
Description: Envarsus® tablets, once daily, oral formulation. Prolonged -release formulation of tacrolimus
Study: NCT02432833
Drug: PROGRAF®
Approvals — FDA: no, EMA: no, PMDA: no
Description: Prograf® hard capsules, twice daily, oral formulation
Study: NCT02432833
Drug: ADVAGRAF®
Approvals — FDA: no, EMA: no, PMDA: no
Description: Advagraf® prolonged-release hard capsules, once daily, oral formulation
Study: NCT00967005
Drug: N Acetyl Cysteine
Approvals — FDA: no, EMA: no, PMDA: no
Description: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks
Study: NCT02493946
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00003664
Drug: fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01777243
Drug: GSK2315698
Approvals — FDA: no, EMA: no, PMDA: no
Description: Unit dose strength: 200 mg/mL stock to be diluted. GSK2315698 will be administered at variable dosed until the concentration of the serum amyloid P component monoclonal antibody (SAP mAb) has fallen below 100 ng/mL.
Study: NCT03954158
Drug: Vehicle
Normalized name: Drug vehicle
Approvals — FDA: no, EMA: no, PMDA: no
Description: BID regimen
Study: NCT03954158
Drug: Vehicle
Normalized name: Drug vehicle
Approvals — FDA: no, EMA: no, PMDA: no
Description: QD regimen
Study: NCT02676323
Drug: Leucovorin
Normalized name: Leucovorin
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Leucovorin (5 mg/m\^2/dose, max 5 mg) may be given PO or IV at 24 and 30 hours after each ITMHA.
Study: NCT00004003
Drug: fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT02460081
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02235389
Drug: Standard therapy
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00240838
Drug: acetaminophen extended release caplets
Normalized name: acetaminophen Extended Release Oral Tablet
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00855868
Drug: florbetapir F 18
Normalized name: Florbetapir F 18
Approvals — FDA: no, EMA: no, PMDA: no
Description: 370 MBq (10 mCi), intravenous (IV) injection, single dose
Study: NCT00855868
Drug: [11C]-PIB
Approvals — FDA: no, EMA: no, PMDA: no
Description: 555 MBq (15 mCi), IV injection, single dose \[11C\]-PIB
Study: NCT03151746
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo pill administered orally 1 hour before planned surgical procedure
Study: NCT03953729
Drug: Ibuprofen
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: The child and his / her guardian shall immediately upon arrival for informed about the participation in the research, being evaluated on the criteria of inclusion and exclusion described above. Soon after the signature by the responsible for the child of the Informed Consent Form (Appendix A), the drug shall be administered at the dosage established by Clark's formula, according to the weight of each child. It will then be evaluated the degree of anxiety of the child in front of the dental treatment using the scale Children's Fear Survey Schedule-Dental Subscale (Barberio, 2017). After 30 minutes of drug administration, treatment will start.
Study: NCT03783676
Drug: Remifentanil
Normalized name: Remifentanil
DrugBank: Remifentanil (DB00899)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Receive remifentanil bolus and infusion guided by an algorithm.
Study: NCT03783676
Drug: Normal saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: Receive normal saline bolus and infusion guided by the remifentanil algorithm.
Study: NCT00706654
Drug: Placebo depot
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo depot was supplied in lyophilized vials.
Study: NCT00706654
Drug: Placebo tablets
Normalized name: placebo Oral Tablet
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo tablets were identical in appearance to the aripiprazole tablets.
Study: NCT00356005
Drug: azithromycin plus artesunate
Normalized name: Artesunate
DrugBank: Artesunate (DB09274)
Approvals — FDA: yes, EMA: yes, PMDA: no
Study: NCT02495766
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single infusion
Study: NCT02978313
Drug: mFOLFOX6
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oxaliplatin+LV5FU2
Study: NCT02978313
Drug: FOLFIRI
Approvals — FDA: no, EMA: no, PMDA: no
Description: Irinotecan+LV5FU2
Study: NCT00895895
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Capsules SAM-531 placebo and 5 mg tablet encapsulated Donepezil placebo capsules, once a day during 24 weeks.
Study: NCT00895895
Drug: SAM-531 1.5 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Capsules SAM-531 1.5 mg, once a day during 52 weeks.
Study: NCT00895895
Drug: SAM-531 3.0 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Capsules SAM-531 3.0 mg, once a day during 52 weeks.
Study: NCT00895895
Drug: SAM-531 5.0 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Capsules SAM-531 5.0 mg, once a day during 24 weeks or 52 weeks.
Study: NCT02931305
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Use iron oxide (brown, black and yellow) to mimic Epimedium Prenylflavonoids Extract.
Study: NCT02956837
Drug: Placebo (Formulation buffer S9b)
Approvals — FDA: no, EMA: no, PMDA: no
Description: A single dose of placebo is administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
Study: NCT02111863
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml 5% dextrose in water (D5W) over 1 hr.
Study: NCT02637323
Drug: FX006 32 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single 5 mL IA injection
Study: NCT02637323
Drug: TCA IR 40
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single 1 mL IA injection
Study: NCT03332784
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: TAK-925 Placebo Intravenous Infusion
Study: NCT00438841
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT00040417
Drug: CAMPATH-IH
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01744704
Drug: rhNGF 0.5 µg/mL Sentinel
Approvals — FDA: no, EMA: no, PMDA: no
Description: In Part 0, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration in the study eye (right or left) according to the randomisation list to achieve the required dose level
Study: NCT01744704
Drug: rhNGF 5 µg/mL Sentinel
Approvals — FDA: no, EMA: no, PMDA: no
Description: Part 0 represented a sentinel group.
Study: NCT01744704
Drug: rhNGF 20 µg/mL Sentinel
Approvals — FDA: no, EMA: no, PMDA: no
Description: In Part 0, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration in the study eye (right or left) according to the randomisation list to achieve the required dose level
Study: NCT01744704
Drug: rhNGF 20 µg/mL Part A
Approvals — FDA: no, EMA: no, PMDA: no
Description: In Part A, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration or placebo in their study eye (right or left) according to the randomisation list (and 1 drop of placebo in the non-study eye). This occurred q4h on Day 1 to achieve the required fractionated single dose level.
Study: NCT01744704
Drug: rhNGF 180 µg/mL Part A
Approvals — FDA: no, EMA: no, PMDA: no
Description: In Part A, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration or placebo in their study eye (right or left) according to the randomisation list (and 1 drop of placebo in the non-study eye). This occurred q4h on Day 1 to achieve the required fractionated single dose level.
Study: NCT01744704
Drug: rhNGF 20 µg/mL Part B
Approvals — FDA: no, EMA: no, PMDA: no
Description: In Part B, as planned 3 dose levels of rh-NGF or placebo eye drops were studied in a total of 40 healthy subjects.
Study: NCT01744704
Drug: rhNGF 60 µg/mL Part B
Approvals — FDA: no, EMA: no, PMDA: no
Description: In Part B, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration or placebo in their study eye (right or left) according to the randomisation list (and 1 drop of placebo in the non-study eye). This occurred q4h for 5 days to achieve the required multiple fractionated dose level.
Study: NCT00991081
Drug: Pharmacotherapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: 8-week course of genetically-tailored pharmacotherapy~* Participants with the A1 allele (TT/CT) were assigned to receive NRT (the Patch)~* Participants with the A2 allele (CC) were assigned to receive bupropion
Study: NCT01744704
Drug: rhNGF 180 µg/mL Part B
Approvals — FDA: no, EMA: no, PMDA: no
Description: In Part B, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration or placebo in their study eye (right or left) according to the randomisation list (and 1 drop of placebo in the non-study eye). This occurred q4h for 5 days to achieve the required multiple fractionated dose level.
Study: NCT01744704
Drug: Placebo Part A
Approvals — FDA: no, EMA: no, PMDA: no
Description: In Part A, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration or placebo in their study eye (right or left) according to the randomisation list (and 1 drop of placebo in the non-study eye). This occurred q4h on Day 1 to achieve the required fractionated single dose level.
Study: NCT01744704
Drug: Placebo Part B
Approvals — FDA: no, EMA: no, PMDA: no
Description: In Part B, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration or placebo in their study eye (right or left) according to the randomisation list (and 1 drop of placebo in the non-study eye). This occurred q4h for 5 days to achieve the required multiple fractionated dose level.
Study: NCT02209181
Drug: JNJ-10450232 / Not yet marketed
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.
Study: NCT00000367
Drug: Suicide prevention treatment
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00938405
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo: 3.75 gms/day in the form of three 625 mg tablets with lunch and dinner or six 625mg tablets once daily with dinner.
Study: NCT00437021
Drug: Placebo (subcutaneous)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 0.9 percent (weight/volume) sodium chloride injection, United States Pharmacopeia \[Sterile Saline Placebo (SSP)\].
Study: NCT00437021
Drug: Placebo (scarification)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Physiologic normal saline for injection.