ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01397968
Conditions: Partial Epilepsy
Keywords: partial onset seizures treatment resistant partial epilepsy
Sponsor: SK Life Science, Inc.
Start date: 2011-07-06; Completion date: 2021-01-28
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs.

Also to evaluate the safety and tolerability of YKP3089.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: YKP3089 intervention 2: Placebo
Intervention descriptions: intervention 1: Capsule, dose to be titrated Tablet, dose to be titrated intervention 2: Placebo capsule Placebo tablet

Protocol documents:
Clinical trial NCT02466243
Conditions: Dermatomyositis
Keywords: JBT-101, lenabasum, dermatomyositis
Sponsor: Corbus Pharmaceuticals Inc.
Start date: 2015-06-01; Completion date: 2021-01-29
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability and efficacy of JBT-101 in adult subjects with skin-predominant, dermatomyositis (DM) that is refractory to at least 3 months treatment with hydroxychloroquine.

Detailed description:
Part A: An interventional, double-blind, randomized, placebo-control design will be used to test JBT-101 in about 22 eligible male or female subjects ≥ 18 and ≤ 70 years of age with moderate-to-severe active skin-predominant dermatomyositis.

Part B: A one-year open-label design to test JBT-101 in subjects who completed Part A without permanent discontinuation of study product because of safety or tolerability reasons.

Arms: arm 1: Part A: JBT-101 20 mg capsule once a day on Days 1-28, then 20 mg capsule twice a day on Days 29-84.

Part B: JBT-101 20 mg twice daily on Days 1 - 365 of the OLE. arm 2: Part A: Placebo capsule once a day on Days 1-28, then placebo capsule twice a day on Days 29-84.

Part B: Placebo twice daily on Days 1 - 365 of the OLE.
Interventions: intervention 1: JBT-101 intervention 2: Placebo
Intervention descriptions: intervention 1: Part A: 20 mg once daily on Days 1-28, then 20 mg twice daily on Days 29-84.

Part B: JBT-101 20 mg twice daily on Days 1 - 365 of the OLE. intervention 2: Part A: Once daily on Days 1-28, then twice daily on Days 29-84.

Part B: Placebo twice daily on Days 1 - 365 of the OLE.

Protocol documents:
Prot_000.pdf: 





















































































































































































































SAP_001.pdf:
Clinical trial NCT04056182
Conditions: Opioid-use Disorder
Keywords: opioid use disorder lofexidine naltrexon-xr
Sponsor: New York State Psychiatric Institute
Start date: 2019-09-01; Completion date: 2021-01-29
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label pilot trial to evaluate the safety and tolerability of lofexidine in the management of opioid withdrawal symptoms while initiating outpatient treatment with naltrexone. The initiation procedure will be a flexible detoxification lasting 2 to 10 days concluding with the injection of XR-Naltrexone (Vivitrol). Vivitrol is a long-acting injection that contains enough medicine to last for one month blocking the effects of opioids.

Detailed description:
This is an open-label pilot trial to evaluate the safety and tolerability of lofexidine in the management of opioid withdrawal symptoms while initiating outpatient treatment with naltrexone. Lofexidine is a nonopioid prescription medicine used in adults to help with the symptoms of opioid withdrawal that may happen when a person stops taking an opioid suddenly. The initiation procedure will be a flexible detoxification lasting 2 to 10 days concluding with the injection of XR-Naltrexone (Vivitrol). Vivitrol is a long-acting injection that contains enough medicine to last for one month blocking the effects of opioids. Lofexidine will be fixed-flexible dosing started on day 1 with maximum dose being three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals. Lofexidine treatment will continue throughout the detoxification, up to 10 days, and will be discontinued with a gradual dose reduction over 2 to 4 days. Precipitated withdrawal symptoms are treated with lofexidine, clonazepam, and other comfort medications. After the induction patients will be seen at the clinic for 8 weeks. Twice weekly for the first month and weekly for weeks 5-8. A second Vivitrol injection will be provided at week 4.

Arms: arm 1: Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol.
Interventions: intervention 1: Lofexidine 0.18 MG
Intervention descriptions: intervention 1: Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol.

Protocol documents:
Prot_SAP_000.pdf: 
Study: # 7812 entitled Lofexidine for management of opioid withdrawal with XR-NTX treatment 
 
PI: Frances R. Levin, MD 
NCT# NCT04056182 
 
Protocol created/approved 8-12-2019 
Data Analysis Plan created 8-15-2019
Clinical trial NCT03071094
Conditions: Hepatocellular Carcinoma (HCC)
Sponsor: Transgene
Start date: 2017-07-27; Completion date: 2021-02-03
Enrollment: 14 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a study to Evaluate the Safety and Efficacy of the Combination of the Oncolytic Immunotherapy Pexa-Vec With the PD-1 Receptor Blocking Antibody Nivolumab in the First-line Treatment of Advanced Hepatocellular Carcinoma (HCC).

Detailed description:

Arms: arm 1: Participants were administered Pexa-Vec (pexastimogene devacirepvec) as 3 bi-weekly intratumoral (IT) injections of 10\^9 pfu at day 1 and weeks 2 and 4 and nivolumab intravenously every 2 weeks (from week 2). arm 2: Participants were administered Pexa-Vec (pexastimogene devacirepvec) as 3 bi-weekly intratumoral (IT) injections of 10\^9 pfu at day 1 and weeks 2 and 4 and nivolumab intravenously every 2 weeks (from week 2).
Interventions: intervention 1: Pexastimogene Devacirepvec (Pexa Vec) intervention 2: Nivolumab
Intervention descriptions: intervention 1: Pexa-Vec (pexastimogene devacirepvec) will be administered as 3 bi-weekly intratumoral (IT) injections of 10\^9 pfu at day 1 and weeks 2 and 4 intervention 2: Nivolumab will be administered intravenously every 2 weeks (from week 2)

Protocol documents:
Prot_000.pdf: 

























































































































































































































































































SAP_001.pdf:
Clinical trial NCT01515306
Conditions: Malignant Solid Tumor
Keywords: Advanced Malignant Solid Tumors
Sponsor: Eli Lilly and Company
Start date: 2012-07-19; Completion date: 2021-02-22
Enrollment: 48 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate whether there are no clinically significant pharmacokinetic effects of concomitant ramucirumab (IMC-1121B) on paclitaxel by investigating the pharmacokinetics (PK) of each in participants with advanced malignant solid tumors.

Part A of this study will investigate the potential of concomitant ramucirumab (IMC-1121B) to affect the pharmacokinetics of paclitaxel. Part B of this study will investigate the pharmacokinetics of ramucirumab (IMC-1121B) as monotherapy.

Detailed description:

Arms: arm 1: Experimental: Part A: ramucirumab (IMC-1121B) and paclitaxel Cycle 1: paclitaxel administered on Day 1 of 2-week cycle. Cycle 2 and beyond : ramucirumab (IMC-1121B) administered on Day 1 and Day 15, paclitaxel administered on Day 1, Day 8 and Day 15 of 4-week cycle. arm 2: Cycle 1: ramucirumab (IMC-1121B) administered as monotherapy on Day 1 of 3-week cycle.

Cycle 2 and beyond: ramucirumab (IMC-1121B) administered on Day 1 and Day 15, paclitaxel administered on Day 1, Day 8 and Day 15 of 4- week cycle.

\*After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A.
Interventions: intervention 1: ramucirumab (IMC-1121B) intervention 2: paclitaxel
Intervention descriptions: intervention 1: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) intravenous infusion, administered on Day 1and Day 15 of each 4-week cycle, unless otherwise specified. intervention 2: paclitaxel 80 milligrams/square meter (mg/m²) intravenous infusion, administered on Days 1, 8 and 15 of each 4-week cycle, unless otherwise specified.

Protocol documents:
Clinical trial NCT01927419
Conditions: Unresectable Melanoma Metastatic Melanoma
Sponsor: Bristol-Myers Squibb
Start date: 2013-08-23; Completion date: 2021-02-26
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to compare the objective response rate, as determined by investigators, of Nivolumab combined with Ipilimumab versus Ipilimumab monotherapy in patients with untreated, unresectable, or metastatic melanoma

Detailed description:

Arms: arm 1: Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion. arm 2: Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
Interventions: intervention 1: Nivolumab intervention 2: Ipilimumab intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Matching nivolumab

Protocol documents:
Clinical trial NCT03245008
Conditions: Osteoarthritis, Knee / Osteoarthritis, Hip
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2017-09-08; Completion date: 2021-03-09
Enrollment: 626 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to verify the superiority of 16 weeks of MT-5547 treatment to placebo, as evidenced by the WOMAC pain score (the efficacy outcome measure), in patients with osteoarthritis of the knee or hip. Additional objectives of the study are to investigate the efficacy, safety, and pharmacokinetics of MT-5547 in long-term use.

Detailed description:
The blind will be maintained, including for the study sponsor, until the key code is opened after the data have been fixed for all subjects in Week 24. In addition, in order to eliminate any bias that could affect the study assessments, to the extent possible, the blind will be maintained with respect to the study site and the subject even after the opening of the study sponsor key code.

Arms: arm 1: MT-5547 Subcutaneous (SC) dosing regimen 1. Naproxen-matching placebo oral after Week 16. arm 2: MT-5547 SC dosing regimen 2. Naproxen-matching placebo oral after Week 16. arm 3: MT-5547-matching placebo SC dosing. Naproxen oral after Week 16.
Interventions: intervention 1: MT-5547 intervention 2: MT-5547-matching placebo
Intervention descriptions: intervention 1: Solution for injection in pre-filled syringe intervention 2: Solution for injection in pre-filled syringe

Protocol documents:
Prot_000.pdf: 









































































































































































































































SAP_001.pdf:
Clinical trial NCT01761266
Conditions: Hepatocellular Carcinoma (HCC)
Keywords: Hepatocellular Carcinoma Neoplasms Cancer
Sponsor: Eisai Limited
Start date: 2013-03-01; Completion date: 2021-03-10
Enrollment: 954 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
E7080-G000-304 is a multicenter, randomized, open-label, noninferiority Phase 3 study to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in participants with unresectable Hepatocellular Carcinoma (HCC).

Detailed description:

Arms: arm 1: Participants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (\>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (\<) 60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. arm 2: Participants received sorafenib 400 mg tablets, orally, twice daily (BID) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Interventions: intervention 1: Lenvatinib intervention 2: Sorafenib
Intervention descriptions: intervention 1: 12 mg (or 8 mg) once daily (QD) oral dosing. intervention 2: 400 mg twice daily (BID) oral dosing.

Protocol documents:
Clinical trial NCT00720941
Conditions: Carcinoma, Renal Cell
Keywords: SUTENT Locally advanced and/or metastatic renal cell carcinoma Pazopanib Sunitinib GW786034 Renal cell carcinoma
Sponsor: Novartis Pharmaceuticals
Start date: 2008-08-14; Completion date: 2021-03-24
Enrollment: 1110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a randomized, open-label, parallel group Phase III non inferiority study to evaluate the efficacy and safety of pazopanib compared with sunitinib in subjects with advanced renal cell carcinoma (RCC) who had not received prior systemic therapy for advanced or metastatic RCC.

Detailed description:
Approximately 876 eligible subjects (approximately 438 per treatment arm) were planned to be enrolled over the course of the study. However, due to higher than expected withdrawal rates and discordance rates between independent review committee (IRC) and investigator assessments of progression, the protocol was amended (Protocol Amendment 4) to increase the number of subjects to approximately 1100 total by including all subjects enrolled in CPZP034A2301 (hereafter referred as Study A2301) and CPZP034A2201 (a sub study of CPZP034A2301, hereafter referred as Study A2201 with NCT01147822).

The subjects were centrally randomized in 1:1 ratio to receive either 800mg pazopanib to be administered once daily orally continuous dosing or 50mg sunitinib to be administered in 6-week cycles: 50mg orally daily for 4 weeks followed by 2 weeks off treatment. Subjects were permitted to receive supportive care throughout the study including transfusion of blood and blood products, treatment with antibiotics, anti-emetics, anti-diarrheal agents, analgesics, erythropoietin, or bisphosphonates, when appropriate. The study treatment continued until subjects experience disease progression, unacceptable toxicity, withdraw consent, or death.

Arms: arm 1: Control arm arm 2: Experimental arm
Interventions: intervention 1: Pazopanib intervention 2: Sunitinib
Intervention descriptions: intervention 1: 800 mg administered once daily orally continuous dosing intervention 2: 50 mg sunitinib to be administered in 6-week cycles: 50mg orally daily for 4 weeks followed by 2 weeks off treatment

Protocol documents:
Clinical trial NCT05014490
Conditions: Bioequivalence Healthy Subjects
Keywords: bioequivalence etoricoxib healthy subjects pharmacokinetics
Sponsor: Darnitsa Pharmaceutical Company
Start date: 2021-02-24; Completion date: 2021-03-24
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (Exib 120 mg etoricoxib film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" \[Ukraine\]) and a Reference medication (marketed medicinal product Arcoxia® 120 mg etoricoxib film-coated tablets, Marketing Authorisation Holder: UAB "Merck Sharp\&Dohme", Lithuania) in healthy volunteers.

Detailed description:

Arms: arm 1: A single oral dose of the test product Exib 120 mg etoricoxib film-coated tablets. arm 2: A single oral dose of the reference product Arcoxia® 120 mg etoricoxib film-coated tablets.
Interventions: intervention 1: Exib 120 mg etoricoxib film-coated tablets intervention 2: Arcoxia® 120 mg etoricoxib film-coated tablets
Intervention descriptions: intervention 1: Oral, COX-2 highly selective, non-steroidal anti-inflammatory generic drug intervention 2: Oral, COX-2 highly selective, non-steroidal anti-inflammatory innovative drug

Protocol documents:
Prot_ICF_000.pdf: 









































































































































































































SAP_001.pdf:
Clinical trial NCT01416636
Conditions: Non-operable Chronic Thromboembolic Pulmonary Hypertension
Sponsor: SciPharm SàRL
Start date: 2009-03-01; Completion date: 2021-04-01
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to determine the effect on six-minute walking test (6MWT) distance after 24 weeks treatment with subcutaneous (SC) Treprostinil Sodium in patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension.

Detailed description:
Chronic thromboembolic pulmonary hypertension (CTEPH) is characterized by non-resolving organized thromboembolic obstructing the pulmonary vascular bed. These thrombi are resistant to thrombolytic therapy and chronic plasmatic anticoagulation. An increase in pulmonary vascular resistance (PVR), right ventricular overload, and eventually right ventricular failure ensue.

The treatment of choice for CTEPH is pulmonary endarterectomy (PEA), providing a potential cure for the disease. However, about 50 % of patients are not candidates for surgery, mainly because of distal location of thromboemboli. Despite recent advances in the treatment of pulmonary arterial hypertension (PAH), medical treatments have not been recommended for inoperable CTEPH, because of the concept that a predominantly major vessel obstructive arteriopathy would not be suitable for vasodilators. Furthermore, a major drawback of i.v. prostacyclin therapy is the need for a permanent central venous access that increases the risk of infection (0.22-0.68 per patient per year), thrombosis and new major vessel thromboembolism.

Arms: arm 1: Arm I (low dose):

Subject was treated with a low dose of Treprostinil sodium. Dose was escalated to an approximate target dose of 3 ng/kg/min after the first 12 weeks and was kept stable for another 12 weeks.

Due to the predefined infusion rate setting schedule an interim dose of up to 6 ng/kg/min could be reached for few days at the end of the phases 1,2 and 3.

This depended on the patient's exact weight and is caused by the limited infusion rate setting possibility of the infusion pump. arm 2: Subject was treated with a low dose of Treprostinil sodium. Dose was escalated to an approximate target dose of 3 ng/kg/min after the first 12 weeks and kept stable for another 12 weeks.

Due to the predefined infusion rate setting schedule an interim dose of up to 6 ng/kg/min could be reached for few days at the end of the phases 1,2 and 3.

This depended on the patient's exact weight and is caused by the limited infusion rate setting possibility of the infusion pump.
Interventions: intervention 1: Treprostinil sodium
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT03314740
Conditions: Ovarian Neoplasms
Sponsor: Mario Negri Institute for Pharmacological Research
Start date: 2017-06-12; Completion date: 2021-04-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase II, randomized, multi-centre study aiming at comparing the efficacy of Olaparib and Cediranib vs. weekly Paclitaxel in terms of progression free survival (PFS) in platinum refractory or resistant recurrent ovarian cancer.

Patients will be randomised in a 1:1:1 ratio to three treatment arms:

* Arm A: Paclitaxel 80 mg/mq every week
* Arm B: Cediranib 20 mg/day + Olaparib 600 mg / day (i.e. 300 mg BD) given every day
* Arm C: Cediranib 20 mg/day given 5 days per weeks + Olaparib 600 mg / day (i.e. 300 mg BD) given 7 days per weeks

Detailed description:
Both the experimental arms (Arm B and C) will be compared with Arm A in terms of PFS.

If both superior to the control (Arm A), they will be compared in terms of gastrointestinal safety.

Arms: arm 1: Intravenous administration of weekly Paclitaxel (dosage: 80 mg/mq) for a maximum of 6 cycles. Cycle is defined as 4 weeks. arm 2: Oral administration of two experimental drugs:

* Cediranib 20 mg/day given 7 days per week
* Olaparib 600 mg / day (i.e. 300 mg twice a day) 7 days per week until progression, unacceptable toxicity, patient or physician decision to discontinue or death. arm 3: Oral administration of two experimental drugs:

* Cediranib 20 mg/day given 5 days per week
* Olaparib 600 mg / day (i.e. 300 mg twice a day) 7 days per week until progression, unacceptable toxicity, patient or physician decision to discontinue or death.
Interventions: intervention 1: Paclitaxel intervention 2: Cediranib intervention 3: Olaparib
Intervention descriptions: intervention 1: Comparator active compound intervention 2: Experimental compound intervention 3: Experimental compound

Protocol documents:
Prot_000.pdf: 



















































































































































































































































SAP_001.pdf: