TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04392037
Drug: Iberdomide plus low-dose cyclophosphamide and dexamethasone
Normalized name: ethinyl estradiol
DrugBank: Ethinylestradiol (DB00977)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Iberdomide, low dose Cyclophosphamide and Dexamethason will be given until progression or unacceptable toxicity
Study: NCT05043298
Drug: IBI 360 Injection
Approvals — FDA: no, EMA: no, PMDA: no
Description: IBI 360 dose level of escalation IV Q3W Day 1
Study: NCT05858047
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered orally, once daily (QD)
Study: NCT05858047
Drug: SYHX1901
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered orally, once daily (QD)
Study: NCT06229977
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive placebo (a tablet that contains no active ingredient) to be taken twice daily for 6 weeks
Study: NCT06229977
Drug: Treatment as Usual (TAU)
Normalized name: Hongo Killer Treatment
Approvals — FDA: no, EMA: no, PMDA: no
Description: subjects will receive a mood stabilizer per usual care
Study: NCT06285643
Drug: AAV2-GDNF Gene therapy
Normalized name: tetracycline
DrugBank: Tetracycline (DB00759)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose
Study: NCT06072781
Drug: Pegylated liposomal doxorubicin
Approvals — FDA: no, EMA: no, PMDA: no
Description: administered intravenously
Study: NCT05878522
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 6 capsules administered Q12 hours for 5 doses
Study: NCT06646783
Drug: [68Ga]Ga-NODAGA-SNA014
Approvals — FDA: no, EMA: no, PMDA: no
Description: Perform whole-body PET/CT scans on the subjects at 30 minutes (± 5 minutes), 60 minutes (± 10 minutes), 120 minutes (± 20 minutes), and 240 minutes (± 30 minutes) after administration. Among them, PET scanning can be performed on 1-2 subjects in a certain dose group or each dose group for 30-60 minutes. Among the four CT scans, one CT scan is a conventional low-dose CT scan (120mA), and the remaining three are extremely low-dose CT scans (10-20mA). The main researchers and nuclear medicine physicians can decide whether to change the subsequent image acquisition time and duration of the subjects based on the image information obtained from the enrolled subjects.
Study: NCT05757622
Drug: Remifentanil
Normalized name: Remifentanil
DrugBank: Remifentanil (DB00899)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Procedural sedation provided with propofol and remifentanil using target controlled infusions
Study: NCT06329661
Drug: Saline solution, 0.6%
Approvals — FDA: no, EMA: no, PMDA: no
Description: Colorless and clear sodium chloride solution (0.6%)
Study: NCT06585774
Drug: INCA034176
Approvals — FDA: no, EMA: no, PMDA: no
Description: IV infusion
Study: NCT06585774
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: IV infusion
Study: NCT06585774
Drug: Corticosteroids
Normalized name: CORTICOSTEROIDS
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral/IV Infusion
Study: NCT04973111
Drug: Placebo as SC Injection
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT06385418
Drug: Colonic local administration of fluorouracil with enhanced adhesion
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Fluorouracil is administered via the colon as an injectable solution at a dose of 500 mg per day for 6 days, along with poloxamer 407 and poloxamer 188 used as thermosensitive hydrogel to enhance adhesion.
Study: NCT05005689
Drug: Fluoride mouthwash (0.05%; 225ppm).
Approvals — FDA: no, EMA: no, PMDA: no
Description: Mouthwash
Study: NCT05005689
Drug: Tooth Mousse Plus
Normalized name: Sus scrofa tooth preparation
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tooth Mousse
Study: NCT05725213
Drug: Metvix® 160 mg/g Creme
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients are treated with Metvix creme and exposed to artificial daylight
Study: NCT05886998
Drug: Heparin
Normalized name: Heparin
DrugBank: Heparin (DB01109)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Heparin sodium (Generic, 5000 IU/ml ampoules)
Study: NCT05414266
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo is acetone. At baseline, the investigator will record the area that will be treated in mm2 . Use of a 1 mm x 1 mm gridded transparency will be used to record the treatment area at baseline. At subsequent visits, the study intervention will be applied to the entire treatment area defined at baseline, regardless of any new hair growth. The assigned study intervention is applied monthly by the PI (or designee) to the treatment areas affected by AA on the scalp and/or eyebrows identified at Baseline. The topical solution is applied with a cotton tip applicator by the PI or their qualified designee. Solution is applied by gently pressing a cotton tip applicator that has been soaked in the study solution against the skin. Treatment is repeated monthly.
Study: NCT05414266
Drug: SADBE 5%
Approvals — FDA: no, EMA: no, PMDA: no
Description: SADBE 5% is a solution of 5% Squaric Acid Dibutyl Ester (SADBE) in acetone. At baseline, the investigator will record the area that will be treated in mm2 . Use of a 1 mm x 1 mm gridded transparency will be used to record the treatment area at baseline. At subsequent visits, the study intervention will be applied to the entire treatment area defined at baseline, regardless of any new hair growth. The assigned study intervention is applied monthly by the PI (or designee) to the treatment areas affected by AA on the scalp and/or eyebrows identified at Baseline. The topical solution is applied with a cotton tip applicator by the PI or their qualified designee. Solution is applied by gently pressing a cotton tip applicator that has been soaked in the study solution against the skin. Treatment is repeated monthly.
Study: NCT04530565
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT04530565
Drug: Doxorubicin Hydrochloride
Normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV
Study: NCT04530565
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV or IT
Study: NCT04674735
Drug: APSLXR
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral coated tablets once a day for 60 days.
Study: NCT05457296
Drug: Hydrocortisone (capsule)
Normalized name: Hydrocortisone
DrugBank: Hydrocortisone succinate (DB14545)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: salivary cortisol measurement at baseline and at one, two, and four hours after hydrocortisone intake.
Study: NCT04767984
Drug: Placebo Administration
Approvals — FDA: no, EMA: no, PMDA: no
Description: Given PO
Study: NCT06290557
Drug: HY_133
Approvals — FDA: no, EMA: no, PMDA: no
Description: A recombinant chimeric bacteriophage endolysin HY-133
Study: NCT06290557
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT06473701
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Dronabinol-matched placebo capsule containing no active substance.
Study: NCT05971186
Drug: Ibuprofen 400 mg
Normalized name: ibuprofen 400 MG
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Dosage Form: Tablet Dosage: 1 tablet of Ibuprofen (400 mg) Frequency: One-time consumption Duration: Pain intensity measured before consumption and two hours after consumption
Study: NCT05805007
Drug: ZVS203e
Approvals — FDA: no, EMA: no, PMDA: no
Description: ZVS203e is a rAAV-mediated gene editing drug that silences RHO mutant protein expression by CRISPR/Cas9 editing system.
Study: NCT05135793
Drug: Takecab
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 tablet contains 20 mg vonoprazan
Study: NCT06286033
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: AG-181 matched-placebo tablets
Study: NCT05415241
Drug: FB2001
Approvals — FDA: no, EMA: no, PMDA: no
Description: Stage 1 (Exploring the dose): Twenty participants will be enrolled for aerosol inhalation of FB2001 once daily for 5 consecutive days. If the drug is well tolerated but efficacy is inadequate, another twenty participants will be enrolled for aerosol inhalation of FB2001 BID for 5 consecutive days.~Stage 2 (Sample size expansion): Another twenty participants will be enrolled for aerosol inhalation of FB2001 once daily or twice daily for 5 consecutive days depending on the result of stage 1.
Study: NCT05285696
Drug: CSB-111
Approvals — FDA: no, EMA: no, PMDA: no
Description: \[68Ga\]-NOTA-hGZP is a PET imaging agent.
Study: NCT06388564
Drug: Corticosteroids
Normalized name: CORTICOSTEROIDS
Approvals — FDA: no, EMA: no, PMDA: no
Description: Corticosteroids will be administered at protocol defined dose.
Study: NCT05266924
Drug: Recombinant Human Follicle Stimulating Hormone 900 IU (66.0 μg) / 1.5mL Solution for Injection in Prefilled Pen
Approvals — FDA: no, EMA: no, PMDA: no
Description: fixed-dose of 225 IU/day, subcutaneous (SC), daily, for 5 days. further dosage will be adjusted till adequate follicular development.
Study: NCT06443606
Drug: Placebo in addition to UDCA therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: * Placebo of Bezafibrate 400 mg and Placebo of Bezafibrate 200 mg in addition to continued UDCA at minimum dose of 12 mg/kg/d.~* Duration 96 weeks placebo /UDCA = daily oral dose.
Study: NCT05268016
Drug: ME3183
Approvals — FDA: no, EMA: no, PMDA: no
Description: ME3183 capsule
Study: NCT05268016
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo capsule
Study: NCT06224036
Drug: JDB0131
Approvals — FDA: no, EMA: no, PMDA: no
Description: JDB0131 benzenesulfonate is a new anti tuberculosis compound based on delamanid. According to the existing results of pre clinical in vitro activity, in vivo efficacy, pharmacokinetics and safety in human body, JDB0131 benzenesulfonate has the same in vivo efficacy, better lung tissue distribution and better safety as delamanid.~In December 2016, JDB0131 obtained the drug clinical approval issued by the CFDA, and were approved the clinical stage research that development of drug-resistant tuberculosis adaptation.
Study: NCT04994314
Drug: nCaF2 primer
Normalized name: Primor
Approvals — FDA: no, EMA: no, PMDA: no
Description: Calcium fluoride nanoparticles was added to conventional orthodontic primers to develop bioactive primer. This primer was examined previously for its biological and physical properties
Study: NCT06224036
Drug: Ethylpyrazine rifampicide (II)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Ethylpyrazine rifampicide (II) is suitable for the first two months of intensive treatment of pulmonary tuberculosis with short-term therapy. This product is a compound preparation, consisting of 0.15g of rifampicin (C43H58N4O12), 0.075g of isoniazid (C6H7N3O), 0.4g of pyrazinamide (C5H5N3O), and 0.275g of ethambutol hydrochloride (C10H24N2O2 · 2HCl) per tablet.
Study: NCT05340439
Drug: IncobotulinumtoxinA 100 UNT [Xeomin]
Normalized name: incobotulinumtoxinA 100 UNT [Xeomin]
Approvals — FDA: no, EMA: no, PMDA: no
Description: In cycle 1, a total body dose of 16U/kg (maximum 400U) of IncobotulinumtoxinA will be injected into the spastic muscles of the affected limbs.~In cycle 2, a total body dose of 19U/kg (maximum 475U) of IncobotulinumtoxinA will be injected. If a dose of 19U/kg is not justified (i.e., for clinical or safety reasons) but BoNT-A treatment is still needed (according to the clinical condition of patients) the same dose injected in cycle 1 (16U/Kg; maximum 400U) may be administered in the cycle 2.~In cycle 3, a total body dose of 22U/kg (maximum 550U) of IncobotulinumtoxinA will be injected. If a dose of 22U/kg is not justified (i.e., for clinical or safety reasons) but BoNT-A treatment is still needed (according to the clinical condition of patients) the same dose injected in cycle 2 (19U/Kg; maximum 600U) may be administered in the cycle 3 (if the patient has been treated with 16U/kg in cycle 2, a dose of 19U/kg may be injected in cycle 3).
Study: NCT05655468
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: strictly identical in appearance with dronedarone,oral administration fed conditions
Study: NCT06446531
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral tablet administered once daily
Study: NCT06231550
Drug: FC084CSA tablets
Approvals — FDA: no, EMA: no, PMDA: no
Description: FC084CSA accelerated doses at 100mg QD, and then started the conventional 3+3 design from 200mg QD.
Study: NCT05092776
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Normal Saline (0.9% Sodium Chloride solution for subcutaneous Injection), 2 mL in the 4 mL-glass vial. The placebo will contain no active pharmaceutical ingredients.
Study: NCT04886362
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Treatment with Placebo in the first 7 days from symptoms onset.
Study: NCT04908800
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo tablet
Study: NCT04789057
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: p.o., once daily
Study: NCT06150417
Drug: Androgen deprivation therapy (ADT)
Normalized name: Monistat Simple Therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Standard androgen deprivation therapy (ADT) will be administered at the discretion of treating physician.
Study: NCT05277350
Drug: SNIPR001
Approvals — FDA: no, EMA: no, PMDA: no
Description: SNIPR001 is a live biotherapeutic product consisting of genetically modified bacteriophages specifically targeting Escherichia coli
Study: NCT05277350
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching placebo
Study: NCT06645509
Drug: TTB gel (dose 1)
Approvals — FDA: no, EMA: no, PMDA: no
Description: A topical administration of Victorhy (TTB gel) to both hands, once daily for 28 days
Study: NCT06645509
Drug: TTB gel (dose 2)
Approvals — FDA: no, EMA: no, PMDA: no
Description: A topical administration of Victorhy (TTB gel) to both hands, once daily for 28 days
Study: NCT06645509
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: A topical administration of a vehicle (Placebo) gel to both hands, once daily for 28 days
Study: NCT05884398
Drug: Androgen-deprivation Therapy (ADT)
Normalized name: Monistat Simple Therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: The choice of ADT will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.
Study: NCT06450275
Drug: Tivicay 50mg, film-coated tablets
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 tablet of Dolutegravir 50mg film-coated tablets
Study: NCT05664061
Drug: ADVAIR DISKUS® 100/50 mcg inhalation powder pre-dispensed/GSK
Approvals — FDA: no, EMA: no, PMDA: no
Description: twice daily inhalation throughout the treatment period
Study: NCT05664061
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: twice daily inhalation throughout the treatment period
Study: NCT06653569
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients in the placebo group will receive one unique dose of placebo. 1 capsule if participant weighs \< 80 kg; 2 capsules (80 mg) if participant weighs ≥ 80 kg.
Study: NCT05249621
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Product containing excipients with no active ingredients
Study: NCT04533750
Drug: Peposertib
Approvals — FDA: no, EMA: no, PMDA: no
Description: Given PO
Study: NCT05928689
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching placebo tablet
Study: NCT06249321
Drug: mFOLFIRINOX plus IMRT
Approvals — FDA: no, EMA: no, PMDA: no
Description: Chemotherapy will be administered according to the newest edition of National Comprehensive Cancer Network (NCCN) guideline and a modified FOLFIRINOX regimen will be the first choice. Patients with advanced pancreatic adenocarcinoma will receive the modified FOLFIRINOX regimen (oxaliplatin \[70 mg per square meter of body surface area\], irinotecan \[130 mg per square meter\], leucovorin \[200 mg per square meter\], and fluorouracil \[2000 mg per square meter\] every 2 weeks). Four-week chemotherapy is considered as a cycle. Patients will be recommended to receive Intensity-Modulated Radiation Therapy (IMRT) after about 2\~6 cycles of chemotherapy. The following treatment after radiotherapy will be applied according to the newest edition of NCCN guideline.
Study: NCT05017883
Drug: TAA05 cell injection
Approvals — FDA: no, EMA: no, PMDA: no
Description: Chimeric antigen receptor T cells (car-t)~Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner,which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells.
Study: NCT02556970
Drug: Diclofenac
Normalized name: Diclofenac
DrugBank: Diclofenac (DB00586)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 75mg intraoperatively
Study: NCT05415644
Drug: hrx0701 tablets
Approvals — FDA: no, EMA: no, PMDA: no
Description: High specification group HRX0701 (FDC) tablets (50 mg / 1000 mg) for a total of 2 tablets (take 1 tablet after meals or on an empty stomach).~Low-spec group HRX0701 (FDC) tablets (50 mg / 850 mg) for a total of 2 tablets (take 1 tablet after meals or on an empty stomach).
Study: NCT02556970
Drug: 0.25% Levobupivicaine intercostal nerve block
Approvals — FDA: no, EMA: no, PMDA: no
Description: Multi-level intercostal blocks will be placed subpleurally under thorascopic visualisation.
Study: NCT05806164
Drug: OnabotulinumtoxinA 100 UNT [Botox]
Normalized name: onabotulinumtoxinA 100 UNT [Botox]
Approvals — FDA: no, EMA: no, PMDA: no
Description: OnabotulinumtoxinA will be prepared by dissolving 100 units into 10 ml of injectable saline. The injection will be an office based procedure, performed per usual care.
Study: NCT05071664
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be administered as a SC injection.
Study: NCT04624672
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Weekly injection of placebo for 4-6 months prior to Roux-en-Y gastric bypass surgery
Study: NCT05728619
Drug: HTMC0435
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral administration.
Study: NCT04694300
Drug: Naproxen
Normalized name: Naproxen
DrugBank: Naproxen (DB00788)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 440 mg by mouth immediately after completion of implant surgery followed by 220 mg 12 hours later.~Then 220 mg every 8 hours for the next two days.
Study: NCT04694300
Drug: Acetaminophen
Normalized name: Acetaminophen
DrugBank: Acetaminophen (DB00316)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1000 mg by mouth immediately after the completion of implant surgery followed by 1000 mg every 6 hours for 3 days after surgery with a maximum daily dose of 3000 mg.
Study: NCT06213324
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Normal saline delivered intravenously
Study: NCT05116891
Drug: G/C
Normalized name: GG/Codeine
Approvals — FDA: no, EMA: no, PMDA: no
Description: G/C/CAN04
Study: NCT06137911
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo orally administered
Study: NCT06504524
Drug: Standard of Care
Approvals — FDA: no, EMA: no, PMDA: no
Description: control arm
Study: NCT06602167
Drug: Doctor-prescribed treatment
Normalized name: Doctor's Choice
Approvals — FDA: no, EMA: no, PMDA: no
Description: Doctor-prescribed treatment: At the beginning of capecitabine, patients will be treated with doctor-recommended medications, including oral celecoxib, topical diclofenac, and other skin protectants.
Study: NCT05279417
Drug: Placebo oral tablet
Normalized name: placebo ORAL TABLET
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo tablet manufactured to match ATI-450 in appearance
Study: NCT05279417
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 15 mg to 25 mg weekly
Study: NCT05929248
Drug: conventional therapy
Normalized name: Monistat Simple Therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.
Study: NCT05929248
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Used once a week in combination with standard treatment
Study: NCT06070350
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be provided to the research pharmacy at each of the clinical sites
Study: NCT06366698
Drug: Venofer 200 MG Per 10 ML Injection
Normalized name: Venofer 200 MG per 10 ML Injection
Approvals — FDA: no, EMA: no, PMDA: no
Description: 200 mg IV every 2 days until the targeted dose
Study: NCT05138133
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo intravenous infusion (IV)
Study: NCT05623761
Drug: BUCCOTHERM® Sensitive Gums with Fluoride
Approvals — FDA: no, EMA: no, PMDA: no
Description: Toothbrushing using standardised technique and pear-sized amount of toothpaste BUCCOTHERM® Sensitive Gums with Fluoride twice daily for 1 month.
Study: NCT05623761
Drug: BUCCOTHERM® Sensitive Gums Fluoride-Free
Approvals — FDA: no, EMA: no, PMDA: no
Description: Toothbrushing using standardised technique and pear-sized amount of toothpaste BUCCOTHERM® Sensitive Gums Fluoride-Free twice daily for 1 month.
Study: NCT06574503
Drug: GP681 40mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: 2X20mg tablets taken orally
Study: NCT06574503
Drug: GP681 Simulant
Normalized name: STAPHYLOCOCCUS SIMULANS
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo tablets matching GP681 40mg
Study: NCT04854083
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: The low-calorie diet (LCD) has a phase run-in period for 13 weeks for all participants including 8 weeks of total LCD followed 5-week gradual re-introduction of food (replacement of the VLCD products by one meal/week). During re-introduction of food, the subjects will be randomly assigned to placebo (subcutaneous administration, dose escalation 0.25 mg once weekly for 4 weeks, 0.5 mg once weekly for 4 weeks, where after 1.0 mg once weekly) until the end of the study (12 months). The participants will receive lifestyle counselling throughout the study.