AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT02648841
Drug: Adjuvant chemotherapy for experimental group
RxNorm normalized name: Streptococcus viridans group
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 6 cycles of SOX adjuvant chemotherapy will be given to the patients in the experimental group. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.
Trial: NCT00799838
Drug: Ketoprofen
RxNorm normalized name: Ketoprofen
DrugBank: Ketoprofen (DB01009)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Formulation: oral solution 20mg/mL~Route of administration: oral~Dose regimen: 1 drop/Kg for children aged between 4 to 6 years old or 25 drops for children from 7 to 11 years old administered t.i.d
Trial: NCT00799838
Drug: Placebo (for Ketoprofen)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Formulation: oral solution~Route of administration: oral~Dose regimen: 1 drop/Kg for children aged between 4 to 6 years old or 25 drops for children from 7 to 11 years old administered t.i.d
Trial: NCT02006641
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Once daily, matching placebo capsules, orally
Trial: NCT04788407
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will receive placebo TID for 7 days
Trial: NCT03579628
Drug: AsiDNA
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All patients will receive a loading dose of AsiDNA iv infusion (D1, D2, D3) followed by weekly iv administrations.~At cycle 1: Part B1: Carboplatin will be administered by a 1 hour IV infusion at D8, 1 hour after the end of AsiDNA infusion. Part B2: Carboplatin will be administered by a 1 hour IV infusion at D8, 1 hour after the end of AsiDNA infusion and Paclitaxel will be administered by a 1 hour IV infusion at D8, D15, D22 or 1 hour after the end of AsiDNA infusion for weekly administrations.~At each other cycle: AsiDNA will be administered on a weekly basis. Part B1: Carboplatin will be administered by a 1 hour IV infusion at D1, 1 hour after the end of AsiDNA infusion. Part B2; Carboplatin will be administered by a 1 hour IV infusion at D1, 1 hour after the end of AsiDNA infusion and Paclitaxel will be administered on a weekly basis by a 1 hour IV infusion.~Patients will continue study treatment until disease progression, unacceptable toxicity or patient's refusal to continue.
Trial: NCT03603977
Drug: Lpv/r+3TC
FDA approved: no
EMA approved: no
PMDA approved: no
Description: It is a simplified therapy regimen study of lopinavir and ritonavir combined with lamivudine for HIV-1 infected patients in the real world of China.
Trial: NCT02744482
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: risedrante placebo tablet (75 mg)
Trial: NCT00738062
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day
Trial: NCT05123976
Drug: Zyprexa® coated tablets 5 mg (Eli Lilly, Nederland B V)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: After an overnight fast of at least 10 hours, a 1 film-coated tablet was administered orally with 240 mL of water .
Trial: NCT00550862
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo
Trial: NCT00844480
Drug: zoledronic acid
RxNorm normalized name: Zoledronic Acid
DrugBank: Zoledronic acid (DB00399)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: zoledronic acid, 5mg, iv
Trial: NCT00844480
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: iv
Trial: NCT01611584
Drug: ALA-induced Fluorescence
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ALA Dose- 20 mg/kg
Trial: NCT00696241
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and olmesartan 40 mg placebo- matching tablets, orally, once daily for up to 6 weeks.
Trial: NCT04060199
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IV infusion
Trial: NCT01005888
Drug: Placebo (saline)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00160134
Drug: SLV320
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04631107
Drug: AD109 dose1- A
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral administration at bedtime
Trial: NCT02013388
Drug: N91115
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given PO daily for 14 days
Trial: NCT02013388
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given PO daily for 14 days
Trial: NCT02013388
Drug: N91115
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given PO only on Day 1
Trial: NCT02013388
Drug: Placebo-Day 1 only
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given PO- only on Day 1 (single dosed to match single dose treatments)
Trial: NCT00542048
Drug: EndoTAG®-1
FDA approved: no
EMA approved: no
PMDA approved: no
Description: EndoTAG®-1 22 mg/m² twice weekly
Trial: NCT00978354
Drug: Normal Saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Continuous intravenous infusion 0.9% normal saline placebo control
Trial: NCT04631107
Drug: AD109 dose2- B
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral administration at bedtime
Trial: NCT04631107
Drug: Placebo- C
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral administration at bedtime
Trial: NCT00971035
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subcutaneous repeating dose
Trial: NCT00718484
Drug: Palifosfamide Tris and Doxorubicin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: On Day 1 of each cycle (21 days), 150 mg/m2 IV (intravenous) palifosfamide tris and 75 mg/m2 IV doxorubicin are administered on the same day. Doxorubicin administration will be initiated approximately 60 minutes after the completion of palifosfamide tris dosing. Palifosfamide tris alone is administered on Days 2 and 3, every 3 weeks (one 21-day cycle).
Trial: NCT00718484
Drug: Doxorubicin
RxNorm normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: On Day 1 of each cycle, 75 mg/m2 doxorubicin is administered IV.
Trial: NCT00376324
Drug: Tigecycline
RxNorm normalized name: Tigecycline
DrugBank: Tigecycline (DB00560)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Each subject will receive 3 IV doses of tigecycline, as 30-minute infusions: Dose 1 = 100 mgDose 2 = 50 mgDose 3 = 50 mg The doses of tigecycline will be administered to the subjects at approximately 12-hour intervals.
Trial: NCT01455181
Drug: NPSP558
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 50, 75, 100 μg
Trial: NCT00171639
Drug: zoledronic acid
RxNorm normalized name: Zoledronic Acid
DrugBank: Zoledronic acid (DB00399)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Trial: NCT01421095
Drug: recombinant FSH
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Each participant will recieve recombinant FSH (150 IU) intravenously
Trial: NCT02799472
Drug: GSK3196165
FDA approved: no
EMA approved: no
PMDA approved: no
Description: GSK3196165 is supplied as liquid and will be administered as SC injection.
Trial: NCT02799472
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 0.9% weight by volume (w/v) sodium chloride solution administered as SC injection.
Trial: NCT02799472
Drug: Folic (or folinic) acid
RxNorm normalized name: Folic Acid
DrugBank: Folic acid (DB00158)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Capsule, tablet or liquid and will be administered orally.
Trial: NCT00871442
Drug: PCEA solution (bupivacaine and fentanyl)
RxNorm normalized name: bupivacaine and meloxicam
FDA approved: no
EMA approved: no
PMDA approved: no
Description: PCEA solution: Bupivacaine 0.0625% with fentanyl 2 mcg/ml
Trial: NCT02140983
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo medication
Trial: NCT01068626
Drug: Rosuvastatin
RxNorm normalized name: Rosuvastatin
DrugBank: Rosuvastatin (DB01098)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 10 mg once daily
Trial: NCT01068626
Drug: Placebo for rosuvastatin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: once daily
Trial: NCT00737893
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
Trial: NCT01046851
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo in a manner similar to the active comparator
Trial: NCT03785509
Drug: DAPT, Statin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Compliance of DATP, Compliance of Statin, Drug Eluting Stent, Bare Metal Stent
Trial: NCT03094442
Drug: Normal saline
RxNorm normalized name: Normal Saline Flush
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Normal saline contains 0.9% weight/ volume of sodium chloride. It is used routinely for intravenous resuscitation and fluid maintenance. Patients in the placebo arm will receive 2 ml of normal saline in the blinded syringe provided by the pharmacy.
Trial: NCT03451916
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Arm 2 Placebo (120 subjects): Placebo (solution comprised of 10% DMSO \[v/v\], 5% HSA \[w/v\], and PlasmaLyte, without cells).
Trial: NCT02167217
Drug: Prednisolone
RxNorm normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Prednisolone (5mg per kg) will be taken on two consecutive days, Friday and Saturday mornings each week with breakfast
Trial: NCT00077116
Drug: cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT02482324
Drug: ALZT-OP1a
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Mast cell stabilizer
Trial: NCT02482324
Drug: ALZT-OP1b
FDA approved: no
EMA approved: no
PMDA approved: no
Description: anti-inflammatory
Trial: NCT04501289
Drug: Pritchard regimen
RxNorm normalized name: Anacin Aspirin Regimen Pill
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants in this arm will receive loading dose as 4g of 20% MgSO4 I.V. over 10 minutes, followed by 5g of 50% MgSO4 I.M. in each buttock. Maintenance doses will be given as 5g of 50% MgSO4 I.M. 4 hourly in alternate buttock until 24 hours for patients with eclampsia and for 24 hours after delivery or after last fit, whichever occurs later, for cohorts with eclampsia.
Trial: NCT02834559
Drug: 5-fluorouracil and low molecular weight heparin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Intraoperative adjuvant application of 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH) via intraocular infusion during routine pars plana vitrectomy (PPV).
Trial: NCT02834559
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Routinely used intraocular infusion with balanced salt solution (BSS) during routine pars plana vitrectomy (PPV).
Trial: NCT00348426
Drug: Botulinum AntiToxin
RxNorm normalized name: Botulinum antitoxin
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00002941
Drug: cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT03427268
Drug: PM060184
FDA approved: no
EMA approved: no
PMDA approved: no
Description: PM060184: 9.3 mg/m2 PM060184 i.v. as a 30-minute infusion via a central or peripheral venous catheter.Dose can be rounded to the first decimal point.~PM060184 will be administered on Day 1 and Day 8 q3wk. (Three weeks=one treatment cycle).
Trial: NCT03950141
Drug: Apatinib and S-1
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Combined with Apatinib (250mg qd po) and S-1 (40-60mg bid d1-14) as maintenance therapy in advanced HER-2 negatived GC
Trial: NCT00933582
Drug: JNJ-39439335; Placebo; Naproxen
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03535194
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered SC
Trial: NCT00334191
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02226926
Drug: Persantin Retard
RxNorm normalized name: Persantin Retard
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02226926
Drug: Acetylsalicylic acid
RxNorm normalized name: ACETYLSALICYLIC ACID
DrugBank: Acetylsalicylic acid (DB00945)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02785874
Drug: Statin
RxNorm normalized name: Statin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Divide HCC patients into two groups under randomization, one is with Statin and the other is without Statin to verify whether Statin could prolong disease-free survival
Trial: NCT02397291
Drug: Myoinositol
RxNorm normalized name: mesoinositol hexanicotinate
DrugBank: Inositol nicotinate (DB08949)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV.
Trial: NCT02397291
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo
Trial: NCT01145807
Drug: TDT067
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Study treatment (TDT 067, Transfersome® vehicle, or non Transfersome® placebo) will be applied twice a day for 48 weeks to the great toenail and the other nails and areas surrounding the nails on the foot. Each application will consist of 5 sprays: 1 spray each to the dorsal, medial, anterior, and frontal part of the great toe and a final spray applied evenly to the nail area of the remaining 4 toes. Patients will be instructed not to wash the treated foot or bathe for at least 4 hours after product application.
Trial: NCT01145807
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Study treatment (TDT 067, Transfersome® vehicle, or non Transfersome® placebo) will be applied twice a day for 48 weeks to the great toenail and the other nails and areas surrounding the nails on the foot. Each application will consist of 5 sprays: 1 spray each to the dorsal, medial, anterior, and frontal part of the great toe and a final spray applied evenly to the nail area of the remaining 4 toes. Patients will be instructed not to wash the treated foot or bathe for at least 4 hours after product application.
Trial: NCT01145807
Drug: Transfersome
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Study treatment (TDT 067, Transfersome® vehicle, or non Transfersome® placebo) will be applied twice a day for 48 weeks to the great toenail and the other nails and areas surrounding the nails on the foot. Each application will consist of 5 sprays: 1 spray each to the dorsal, medial, anterior, and frontal part of the great toe and a final spray applied evenly to the nail area of the remaining 4 toes. Patients will be instructed not to wash the treated foot or bathe for at least 4 hours after product application.
Trial: NCT02358304
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02732405
Drug: MK5172 /MK8742
FDA approved: no
EMA approved: no
PMDA approved: no
Description: tablets of MK-5172 100 mg/MK-8742 50 mg will be administered orally, daily for 12 weeks without ribavirin
Trial: NCT00118261
Drug: fluorouracil
RxNorm normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Starting with course 2: fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Trial: NCT00118261
Drug: leucovorin calcium
RxNorm normalized name: Leucovorin Calcium
DrugBank: Leucovorin (DB00650)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Starting with course 2: Leucovorin calcium IV over 2 hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Trial: NCT01472939
Drug: Placebo + PPI
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo t.i.d. taken in addition to a PPI
Trial: NCT01282801
Drug: Effexor® XR
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 150 mg Extended-Release Capsule
Trial: NCT03615781
Drug: Four week's arm - drugs
FDA approved: no
EMA approved: no
PMDA approved: no
Description: After the surgical implant removal, the investigators prescribe a total of 4 weeks of systemic targeted antibiotic therapy against the causative pathogen(s), of which one week is recommended to be intravenously.
Trial: NCT00187915
Drug: Mycophenolate mofetil + Tacrolimus
RxNorm normalized name: Mycophenolate Mofetil
DrugBank: Mycophenolate mofetil (DB00688)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Target MPA exposure to 30-60 mg/L/h during first month post-transplant
Trial: NCT00187915
Drug: Mycophenolate mofetil + Cyclosporin
RxNorm normalized name: Mycophenolate Mofetil
DrugBank: Mycophenolate mofetil (DB00688)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Target MPA exposure to 30-60 mg/L/h during first month post-transplant
Trial: NCT00552032
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo nasal spray 1 puff per nostril twice daily x 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
Trial: NCT01378910
Drug: Unique
RxNorm normalized name: ALCOHOL 70 mL in 100 mL TOPICAL GEL [UNIQUE Hand Sanitizer]
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Change of PI, NNRTI or integrase inhibitor to CCR5 antagonist (maraviroc)
Trial: NCT02124148
Drug: Fluorouracil
RxNorm normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Administered IV
Trial: NCT02124148
Drug: LY3023414
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered PO
Trial: NCT02124148
Drug: Leucovorin
RxNorm normalized name: Leucovorin
DrugBank: Leucovorin (DB00650)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Administered IV
Trial: NCT03002038
Drug: Azathioprine
RxNorm normalized name: Azathioprine
DrugBank: Azathioprine (DB00993)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Patients are started with Azathioprine 50 mg tablets, taken orally twice a day. The medication dose is increased gradually with the aim of lymphocytes count bellow 1500 and to the maximum dose of 3 g Azathioprine per day. Cell blood count is checked once a week in the first month of treatment, once every two weeks in the second month of treatment, and monthly in the third month of treatment to make decision about medication dose.
Trial: NCT03351738
Drug: MEDI5884
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.
Trial: NCT03351738
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive SC dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
Trial: NCT01049854
Drug: Full Intensity
RxNorm normalized name: Full Marks
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients will start their pre-conditioning regimen on Day -9. Patients will receive busulfan twice daily on Days - 8, -7, -6, and -5 and Melphalan on Days -4, -3 and -2 and rabbit antithymocyte globulin on Days -4, -3, -2 and -1 with stem cell infusion on Day 0. GM-CSF hematopoietic growth factor will start on Day 0. GVHD prophylaxis will consist of tacrolimus only.
Trial: NCT04439825
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Saline solution (preservative free)
Trial: NCT00896428
Drug: Placebo.
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 tablet morning and evening for 12 months
Trial: NCT04309929
Drug: Analgesics
RxNorm normalized name: ANALGESICS
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All patients will undergo the anesthesiological and surgical treatment provided for the patient's clinical conditions and in no case will the patients undergo a change in the normal diagnostic-therapeutic path due to participation in this study.
Trial: NCT00249795
Drug: placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: oral administration (tablets) once daily
Trial: NCT02566798
Drug: Lactose
RxNorm normalized name: Lactose
DrugBank: Lactose (DB04465)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients are taking capsules of placebo 3 times a day in the morning, at noon and in the evening during 7 days.~Blood samples and synovial fluid are performed on D0 and D7
Trial: NCT00943371
Drug: MK6349
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Panel A: MK6349 in single doses beginning at 16 mg and rising to 90 mg in up to four treatment periods Panel B: MK6349 in single doses beginning at 90 mg and rising to 160 mg in up to four treatment periods Panel C: MK6349 in divided doses beginning at 20 mg q.a.c. (before each meal) and rising to 50 mg q.a.c. in up to four treatment periods
Trial: NCT00943371
Drug: Comparator: Placebo to MK6349
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Panel A: Placebo to MK6349 in single doses in up to four treatment periods Panel B: Placebo to MK6349 in single doses in up to four treatment periods Panel C: MK6349 in divided doses q.a.c. (before each meal) in up to four treatment periods
Trial: NCT01954368
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
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 planned weight-based volume of intranasal placebo (normal saline solution).~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.