AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT01954368
Drug: Sufentanil
RxNorm normalized name: Sufentanil
DrugBank: Sufentanil (DB00708)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: As soon as possible from ED admission, using a study drug volume schedule, triage nurse will administer to the patient a weight-based volume (corresponding to 0,4 mcg/kg) of intranasal sufentanil.~Half of the dose will be administrated in each nostril. The patient will then rapidly be brought to emergency room and after his pain being reassessed, appropriate treatment (following current recommendations) will be given by the ED nurse.
Trial: NCT03635489
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo matched to bevacizumab IV infusion on Day 1 of each 21-day cycle.
Trial: NCT04787510
Drug: low molecular weight Heparin as standard of care treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: STANDARD OF CARE
Trial: NCT02766621
Drug: Placebo injection SC/IV
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Comparison of Placebo to different doses of PF-06823859
Trial: NCT00092339
Drug: Comparator: valdecoxib, placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01986101
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo comparator
Trial: NCT01986101
Drug: SM-13496
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6
Trial: NCT01986101
Drug: SM-13496
FDA approved: no
EMA approved: no
PMDA approved: no
Description: SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6
Trial: NCT01358578
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept
Trial: NCT01693692
Drug: TD-9855 Group 1
RxNorm normalized name: Streptococcus viridans group
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01693692
Drug: TD-9855 Group 2
RxNorm normalized name: Streptococcus viridans group
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01693692
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00693576
Drug: simvastatin
RxNorm normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 20 mg simvastatin daily
Trial: NCT02400645
Drug: Ketorolac
RxNorm normalized name: Ketorolac
DrugBank: Ketorolac (DB00465)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Ketorolac 30mg to be given IV at end of surgical procedure unless contraindicated.
Trial: NCT00405639
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Normal saline will be used for placebo.
Trial: NCT02402296
Drug: β-1,3/1,6-D-glucan
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days.
Trial: NCT02459158
Drug: ME1100 inhalation solution
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Low dose of ME1100 inhalation solution twice daily for up to 14 days to be administered via eFlow nebulizer system
Trial: NCT02459158
Drug: ME1100 inhalation solution
FDA approved: no
EMA approved: no
PMDA approved: no
Description: High dose of ME1100 inhalation solution twice daily for up to 14 days to be administered via eFlow nebulizer system
Trial: NCT01211483
Drug: U3-1287
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Liquid 70 mg/mL for IV infusion at high dose or low dose
Trial: NCT01211483
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo liquid matching U3-1287 for IV infusion
Trial: NCT01276691
Drug: 81 mg enteric coated aspirin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 81 mg enteric coated aspirin will be provided both as an acute dosage immediately prior to firefighting (1 hour pre-activity) and as a 14 day dosage prior to firefighting
Trial: NCT00913185
Drug: Acne Free, Proactiv
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01743794
Drug: Saline solution 0.9%
FDA approved: no
EMA approved: no
PMDA approved: no
Description: wound infusion, 0.9%, bolus 10mL followed by 8 mL/h
Trial: NCT00006033
Drug: methotrexate
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT03193749
Drug: Placebo Oral Tablet
RxNorm normalized name: placebo ORAL TABLET
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo for tablets of 200 mg of Amiodarone
Trial: NCT03122613
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 3g of Curcumin Placebo per day
Trial: NCT00789971
Drug: Maxitriol
FDA approved: no
EMA approved: no
PMDA approved: no
Description: one month of topical G. Dexamethasone 0.1% with Neomycin sulphate 3500IU/g
Trial: NCT03916601
Drug: SAR341402
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pharmaceutical form: solution for injection~Route of administration: subcutaneous
Trial: NCT00616603
Drug: Normal Saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2ml of normal saline given once intravenously.
Trial: NCT03916601
Drug: SAR341402
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pharmaceutical form: suspension for injection~Route of administration: subcutaneous
Trial: NCT01893827
Drug: XR-NTX (Extended-Release Naltrexone)
RxNorm normalized name: Extended Release Suspension
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 380mg (4cc) XR-NTX administered by IM injection 1x/month for 6 months.
Trial: NCT02425722
Drug: ASP0456
FDA approved: no
EMA approved: no
PMDA approved: no
Description: oral
Trial: NCT02425722
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: oral
Trial: NCT03570554
Drug: Naproxen Sodium (Aleve, BAY117031)
RxNorm normalized name: Naproxen
DrugBank: Naproxen (DB00788)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 660 mg daily for 3 days, 440 mg on the fourth day, over-encapsulated tablet, oral (Treatment A)
Trial: NCT03570554
Drug: Celecoxib
RxNorm normalized name: Celecoxib
DrugBank: Celecoxib (DB00482)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 200 mg daily for 3 days, 100 mg on the fourth day, over-encapsulated capsule, oral (Treatment C)
Trial: NCT03570554
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Over-encapsulation capsule, 4 days, oral (Treatment D)
Trial: NCT00328159
Drug: Oil special 107 and MYGLIOL 810
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03563170
Drug: Capecitabine
RxNorm normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
Trial: NCT03563170
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: anhydrous
Trial: NCT03563170
Drug: Leucovorin
RxNorm normalized name: Leucovorin
DrugBank: Leucovorin (DB00650)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Leucovorin calcium salt
Trial: NCT01642485
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Comparison of different meals effect on Moxifloxacin PK profile
Trial: NCT02697136
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 0.9% Sodium Chloride Injection, USP
Trial: NCT02245620
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo administered as intravenous infusion at a rate of 60 mL/hour for 2 hours
Trial: NCT01316770
Drug: Placebo Parotid Irrigation
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Irrigation of the parotid gland on the opposite side of the mouth with placebo saline.
Trial: NCT01920048
Drug: Drug Therapy for Heart Failure
RxNorm normalized name: porcine heart preparation
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The optimal combination of drugs and doses for each patient will be individualized and will be determined by his/her physician, in accordance with local and international clinical practice guidelines
Trial: NCT00035256
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00455520
Drug: CG5503
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 100, 150, 200, 250 mg twice daily given for up to 15 weeks
Trial: NCT00455520
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: matching placebo twice daily for 12 weeks
Trial: NCT01733043
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00889473
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: gelatin capsule
Trial: NCT02232152
Drug: fluorouracil
RxNorm normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV
Trial: NCT03197870
Drug: AKB-9778
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subcutaneous AKB-9778 15mg
Trial: NCT03197870
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subcutaneous Placebo
Trial: NCT04210375
Drug: JK07
RxNorm normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Recombinant fusion protein consisting of a fully humanized immunoglobulin G1 monoclonal antibody and an active polypeptide fragment of the human growth factor NRG-1
Trial: NCT04210375
Drug: Matching Placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Vehicle control
Trial: NCT00623649
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dose escalation study with a full review of all safety data following each cohort.
Trial: NCT01477294
Drug: Caffeine
RxNorm normalized name: Caffeine
DrugBank: Caffeine (DB00201)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 5 mg/ kg of body weight (capsules), twice a day (morning and afternoon), during 4 days.
Trial: NCT01477294
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Malt dextrin (5 mg/kg body mass) twice a day during 4 days
Trial: NCT03037736
Drug: Normal saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Normal saline will be used as the placebo.
Trial: NCT01122940
Drug: Epamin: Reference Drug
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single dose of 75 mg (10 ml in suspension) of Epamin
Trial: NCT01122940
Drug: Phenytoin: Study Drug
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single dose of 75 mg (10 ml in suspension) of Phenytoin
Trial: NCT02143830
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Arms A, B and C - Cytoxan will be given as a 1-2 hour infusion for 4 days. The dose will be adjusted according to patients ideal body weight for obese patients.
Trial: NCT00110916
Drug: Intra-articular metHuIL-1ra (anakinra)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: anakinra
Trial: NCT00110916
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo
Trial: NCT03488225
Drug: Doxorubicin Hydrochloride
RxNorm normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT03488225
Drug: Leucovorin Calcium
RxNorm normalized name: Leucovorin Calcium
DrugBank: Leucovorin (DB00650)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV
Trial: NCT03488225
Drug: Mercaptopurine
RxNorm normalized name: Mercaptopurine
DrugBank: Mercaptopurine (DB01033)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given PO
Trial: NCT03488225
Drug: Methotrexate
RxNorm normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IT, IV or PO
Trial: NCT03448939
Drug: S5G4T-2
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Once a day topical cream
Trial: NCT00061022
Drug: NXY-059
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02213094
Drug: Nicotinamide 500 mg
DrugBank: Nicotinamide (DB02701)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Nicotinamide 500 mg taken by mouth each morning
Trial: NCT02213094
Drug: Nicotinamide 1000 mg
DrugBank: Nicotinamide (DB02701)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Nicotinamide 1000 mg taken by mouth each morning
Trial: NCT01701089
Drug: RO4602522
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Multiple doses of RO4602522 for 14 days
Trial: NCT02861417
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV
Trial: NCT00374218
Drug: Sucromalt
RxNorm normalized name: SucroMate
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02970019
Drug: K0706
RxNorm normalized name: Ketoprofen
DrugBank: Ketoprofen (DB01009)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Once a day administration after fast
Trial: NCT02652455
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: All participants: Lymphodepleting chemotherapy intravenously, beginning 3 to 6 weeks after tumor collection for TIL growth.
Trial: NCT02970019
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Once a day administration after fast
Trial: NCT01674348
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT01733459
Drug: DLBS3233
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 DLBS3233 capsule 100 mg once daily for 6 months
Trial: NCT01733459
Drug: Placebo capsule of DLBS3233
RxNorm normalized name: PLACEBO CAP/TAB
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 placebo capsule of DLBS3233 once daily for 6 months
Trial: NCT01678755
Drug: ABT-126
RxNorm normalized name: ABT-925
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ABT-126 High Dose
Trial: NCT01678755
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT04603794
Drug: 0.9% Normal Saline
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Commercially Available Over the Counter Standard Formulations USP (United States Pharmacopeia)
Trial: NCT01504984
Drug: SYO-1126
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Imatinib 400mg/tablet, PO, 1 tablet once daily for I\&II D1(crossover)
Trial: NCT03478306
Drug: Melatonin 4 mg Tablet
RxNorm normalized name: Melatonin Tablets
DrugBank: Melatonin (DB01065)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Participants are randomized into arm 1 or arm2, recieving melatonin or placebo, respectively, for 21 days, followed by 1 week of washout, and then swichting to the contralateral treatment arm.
Trial: NCT03855384
Drug: TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU)
RxNorm normalized name: 5-FU
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: TQB2450 1200mg IV ，cisplatin 75 mg/m\^2 IV or carboplatin AUC 5 IV on Day 1 of each week in 3-week cycles (6 cycle maximum); plus 5-FU 750 mg/m\^2/day IV continuous from Day 1-5 of each 3- week cycle (6 cycle maximum).
Trial: NCT03855384
Drug: placebo+cisplatin or carboplatin + 5-Fluorouracil (5-FU)
RxNorm normalized name: 5-FU
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: placebo 1200mg IV ，cisplatin 75 mg/m\^2 IV or carboplatin AUC 5 IV on Day 1 of each week in 3-week cycles (6 cycle maximum); plus 5-FU 750 mg/m\^2/day IV continuous from Day 1-5 of each 3- week cycle (6 cycle maximum).
Trial: NCT00982527
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Saline continuous infusion during cardiopulmonary by pass at 1 ml/h
Trial: NCT00870168
Drug: chemotherapy
RxNorm normalized name: Chemotherapy Glove SML
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01684540
Drug: Sinupret forte
RxNorm normalized name: Erythroped Forte
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02290002
Drug: Calcium Dobesilate
RxNorm normalized name: CALCIUM DOBESILATE
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given at day of HCG injection and for 21 days
Trial: NCT00070642
Drug: CPG 7909 Injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.
Trial: NCT00070642
Drug: Chemotherapy
RxNorm normalized name: Chemotherapy Glove SML
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Chemotherapy in three-week cycles until disease progression:~dacarbazine 850mg/m2
Trial: NCT00070642
Drug: CPG 7909 Injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: CPG 7909 Injection administered subcutaneously at a dose of 10 mg weekly.
Trial: NCT00947024
Drug: 10 mg Glucotrol Tablet (Roerig), Administered Immediately After a Standard Breakfast.
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03684824
Drug: Long luteal phase GnRH agonist protocol
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pituitary suppression will be done using daily subcutaneous injection of triptorelin acetate ( Decapeptyl 0.1mg, Ferring, Germany). Starting from day 21 of the previous cycle
Trial: NCT01580839
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo provided as 50mg lyophilised powder to be reconstituted with sterile water in glass vials indistinguishable from active drug
Trial: NCT03684824
Drug: Gonadotropins
RxNorm normalized name: GONADOTROPINS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Controlled ovarian hyperstimulation will be done using daily intramuscular injection of highly purified Human Menopausal Gonadotrophins (Merional 75 IU/ml, IBSA, Switzerland), starting from day 2-3 of the stimulated cycle, total dose will be adjusted according to patient response
Trial: NCT00648466
Drug: Imitrex® Tablets 100 mg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 100mg, single dose fasting
Trial: NCT06092736
Drug: Compound Danshen Dropping Pills
RxNorm normalized name: DANSHEN
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dosage of Compound Danshen Dropping Pills: 20 capsules each time, 3 times a day, after meals. The follow-up period was 6 months.
Trial: NCT06092736
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo (appearance is the same as Compound Danshen Dropping Pills, main ingredient: starch. Production unit: Tianjin Tasly Co., Ltd.), orally after meals, 3 times a day , 20 capsules each time.
Trial: NCT02418065
Drug: Testosterone
RxNorm normalized name: Testosterone
DrugBank: (1,2,6,7-3H)Testosterone (DB14093)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02418065
Drug: Oral nutritional supplementation
RxNorm normalized name: Ocean Blue Nutritionals Omega-3 1450 Oral Product
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00006305
Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers
Trial: NCT01236950
Drug: Delmopinol mouthrinse
RxNorm normalized name: delmopinol
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Commercial mouthrinse with manufacturer's use indication
Trial: NCT01569750
Drug: Part 1, Cohort 1
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Type=exact number, unit=mg, number=280, form=capsule, route=oral use. Escalating doses of ibrutinib (starting on Day 3 for Cycle 1 and on Day 1 for subsequent cycles) administered once daily in with standard-of-care doses of R-CHOP until maximum tolerated dose is achieved.
Trial: NCT01569750
Drug: Part 1, Cohort 2
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Type=exact number, unit=mg, number=420, form=capsule, route=oral use. Escalating doses of ibrutinib (starting on Day 3 for Cycle 1 and on Day 1 for subsequent cycles) administered once daily in with standard-of-care doses of R-CHOP until maximum tolerated dose is achieved.
Trial: NCT01569750
Drug: Part 1, Cohort 3
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Type=exact number, unit=mg, number=560, form=capsule, route=oral use. Escalating doses of ibrutinib (starting on Day 3 for Cycle 1 and on Day 1 for subsequent cycles) administered once daily in with standard-of-care doses of R-CHOP until maximum tolerated dose is achieved.
Trial: NCT03214614
Drug: GLPG2451 multiple dose
FDA approved: no
EMA approved: no
PMDA approved: no
Description: GLPG2451 oral suspension, multiple ascending doses, daily for 14 days
Trial: NCT03214614
Drug: Placebo multiple dose
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo, oral suspension, daily for 14 days
Trial: NCT03214614
Drug: GLPG2451/GLPG2222 multiple dose
FDA approved: no
EMA approved: no
PMDA approved: no
Description: GLPG2451 oral suspension and GLPG2222 oral suspension, multiple doses, daily for 14 days
Trial: NCT03214614
Drug: Combined Placebo multiple dose
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Combined Placebo, oral suspension, daily for 14 days
Trial: NCT01569750
Drug: Part 2, Cohort 1
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Ibrutinib at the recommended Part 1 dose administered once daily with standard-of-care doses of R-CHOP in patients with newly diagnosed diffuse large B-cell lymphoma.
Trial: NCT01569750
Drug: Part 2, Cohort 2
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Ibrutinib at the recommended Part 1 dose administered once daily with standard-of-care doses of R-CHOP in patients with newly diagnosed with B-cell non-Hodgkin lymphoma.
Trial: NCT02603822
Drug: Indomethacin
RxNorm normalized name: Indomethacin
DrugBank: Indomethacin (DB00328)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Subjects will receive six 25 mg capsules of Indomethacin (immediate release). The subjects will take 3 capsules 8 hours before the timing of visit 5 (before fasting), and 3 additional capsules 30 minutes before visit 5.