ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01724359
Conditions: Schizophrenia
Keywords: Schizophrenia Paliperidone extended-release (ER) Antipsychotic agents
Sponsor: Janssen-Cilag, S.A.
Start date: 2008-02-01; Completion date: 2009-11-01
Enrollment: 95 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate efficacy, safety and tolerability of flexible, once-daily doses of paliperidone extended-release (ER) in patients with schizophrenia from Argentina and Colombia that previously failed treatment with other antipsychotic agents.

Detailed description:
This is a single arm (one group of patients), open-label (all people know the identity of the intervention) multicenter 6-month study. Throughout the study flexible dosing of paliperidone ER in a range of 3 to 12 mg/day may be used. Flexible dosing will allow investigators to adjust the dosage of each patient based on the individual needs. Patients will receive 3, 6, 9 or 12 mg of paliperidone ER once daily for 6 months. The tablets will be taken orally. Adjustment of the dosage will be done at the investigator's discretion, based on the individual patient's clinical response and tolerability to the study drug.

Arms: arm 1: None
Interventions: intervention 1: Paliperidone ER
Intervention descriptions: intervention 1: The recommended Paliperidone extended-release (ER) dose will be 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily. Adjustment of the dosage will be done at the investigator's discretion.

Protocol documents:
Clinical trial NCT01799590
Conditions: Migraine
Keywords: Migraine Topiramate
Sponsor: Janssen Pharmaceutical K.K.
Start date: 2007-08-01; Completion date: 2009-11-01
Enrollment: 296 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of topiramate in participants with migraine (type of severe headache that occurs periodically and is often associated with nausea, vomiting and constipation or diarrhea) who completed the JNS019-JPN-02 study.

Detailed description:
This is an open-label (all people know the identity of the intervention), multicenter (conducted in more than one center), dose-titration (dose escalation/reduction) study of topiramate in participants with migraine. This study is a continuous study for the participants who were enrolled in the JNS019-JPN-02 study. Participants who completed the JNS019-JPN-02 study will receive treatment for 52 weeks starting at Visit 4 of the JNS019-JPN-02 study. The present study will consist of 3 weeks of Transfer period (during this period the dose titration will take place and along with dose titration the new treatment will be initiated at 25 milligram per day \[25mg/day\]), Continuous treatment period (32 weeks), Exit period (up to 3 weeks) and Follow-up period (4 weeks). Participants in the Continuous treatment period will receive topiramate tablets orally in the dose range of 50 mg/day to 100 mg/day. Dose can be increased or decreased as per Investigator's discretion. The maximum daily dose will be 200 mg/day. Efficacy will be primarily evaluated by change from Baseline in the number of monthly migraine attacks in Continuous treatment period. Participants' safety will be monitored throughout the study.

Arms: arm 1: None
Interventions: intervention 1: Topiramate
Intervention descriptions: intervention 1: Topiramate tablets will be administered orally in the dose range of 50 to100 milligram per day (mg/day). Dose will be increased or decreased as per Investigator's discretion. Maximum daily dose limit will be 200 mg.

Protocol documents:
Clinical trial NCT02284854
Conditions: Epilepsy
Sponsor: Bial - Portela C S.A.
Start date: 2009-07-01; Completion date: 2009-11-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ pharmacokinetics.

Detailed description:
Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ pharmacokinetics. Each patient participated in the study for approximately 9 weeks. The clinical portion of the study was completed in approximately 3 months. Subjects received the treatments during 35 days.

Arms: arm 1: Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily arm 2: Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
Interventions: intervention 1: BIA 2-093 intervention 2: Carbamazepine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00857857
Conditions: Asthma
Keywords: asthma late phase response allergen challenge GW870086X
Sponsor: GlaxoSmithKline
Start date: 2009-02-16; Completion date: 2009-11-03
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study will measure the early and late asthamtic response using an allergen challenge. This study will evaluate the safety and patients tolerance to repeat inhaled doses of GW870086X using a number of clinical and biological markers.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: GW870086X intervention 2: FP intervention 3: Placebo
Intervention descriptions: intervention 1: Investigational product intervention 2: Positive control intervention 3: Placebo control

Protocol documents:
Clinical trial NCT00537017
Conditions: Parkinson Disease Neurodegenerative Diseases Central Nervous System Diseases Movement Disorders Brain Diseases
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-11-23; Completion date: 2009-11-19
Enrollment: 140 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the long term safety of SCH 420814 (preladenant) in participants with moderate to severe Parkinson's Disease who are taking an L-Dopa/dopa decarboxylase inhibitor and/or dopamine agonist. All participants must have participated in the main study (P04501; NCT00406029) entitled "A Phase 2, 12 Week, Double Blind, Dose Finding, Placebo Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814 Doses in Subjects With Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias."

Detailed description:

Arms: arm 1: Preladenant 5 mg twice daily (BID) given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
Interventions: intervention 1: Preladenant intervention 2: L-dopa intervention 3: Other Parkinson's Disease treatments
Intervention descriptions: intervention 1: 5 mg BID capsules intervention 2: Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease. L-dopa is often administered concomitantly with a dopa decarboxylase inhibitor (e.g., carbidopa). intervention 3: Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O methyl transferase (COMT) inhibitor entacapone.

Protocol documents:
Clinical trial NCT00545584
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-04-01; Completion date: 2009-11-19
Enrollment: 1512 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy of three strategies of lifestyle changes associated with Januvia (sitagliptin) 100 mg/day in patients with Type 2 Diabetes Mellitus (T2DM) inadequately controlled by metformin (hemoglobin A1c \[HbA1c\] 6.5-9%). A difference between the three strategies of lifestyle changes was expected.

Detailed description:

Arms: arm 1: Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: No specific intervention (standard recommendation) on physical exercise and diet. arm 2: Subjects received sitagliptin 100 mg once daily for 26 Weeks,

and:

Intervention on diet which includes advice on diet with a leaflet and a diary arm 3: Subjects received sitagliptin 100 mg once daily for 26 Weeks,

and:

Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week.
Interventions: intervention 1: sitagliptin phosphate intervention 2: Comparator: Diet intervention 3: Comparator: Physical Activity
Intervention descriptions: intervention 1: sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks intervention 2: Diet intervention 3: Physical Activity

Protocol documents:
Clinical trial NCT00631657
Conditions: Sleep Initiation and Maintenance Disorders Mental Disorders Dyssomnias Sleep Disorders Sleep Disorder, Intrinsic
Keywords: placebo controlled randomized double blind
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-03-04; Completion date: 2009-11-19
Enrollment: 460 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the long-term efficacy and safety of treatment with esmirtazapine (Org 50081, SCH 900265, MK-8265) compared to placebo, in participants with chronic primary insomnia. Primary efficacy variable is Total Sleep Time (TST).

Detailed description:
Insomnia is a common complaint or disorder throughout the world. About one third of the population in the industrial countries reports difficulty initiating or maintaining sleep, resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer chronically from their complaints.

The maleic acid salt of Org 4420, code name Org 50081 (esmirtazapine), was selected for development in the treatment of insomnia. The first clinical trial with esmirtazapine was a proof-of-concept trial with a four-way cross-over design. All 3 esmirtazapine dose groups showed a statistically significant positive effect on TST (objective and subjective) and Wake Time After Sleep Onset (WASO), as compared to placebo.

The current study is designed to assess the long-term efficacy and safety of esmirtazapine in a double-blind, randomized, placebo-controlled, parallel group outpatient trial in participants suffering from chronic primary insomnia. During the 6-month treatment period, participants are randomly assigned to receive either esmirtazapine or placebo. Then, during the 7-day discontinuation period, participants who received esmirtazapine in the 6-month treatment period are randomly assigned to receive either esmirtazapine or placebo, while participants who received placebo in the 6-month treatment period continue to receive placebo.

Arms: arm 1: Participants receive esmirtazapine 4.5 mg tablets, administered once a day for 6 months arm 2: Participants receive placebo tablets, administered once a day for 6 months
Interventions: intervention 1: Esmirtazapine intervention 2: Placebo
Intervention descriptions: intervention 1: One esmirtazapine 4.5 mg tablet once a day intervention 2: One placebo tablet once a day

Protocol documents:
Clinical trial NCT02694536
Conditions: Pancreatic Cancer
Sponsor: Hoffmann-La Roche
Start date: 2006-08-01; Completion date: 2009-11-19
Enrollment: 80 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single-arm, multicenter trial is designed to evaluate the safety of erlotinib in combination with standard of care chemotherapy (gemcitabine) in participants with locally advanced, unresectable, or metastatic pancreatic cancer.

Detailed description:

Arms: arm 1: Participants will receive erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason.
Interventions: intervention 1: Erlotinib intervention 2: Gemcitabine
Intervention descriptions: intervention 1: Participants will receive erlotinib tablets as 100 milligrams (mg) orally (PO) once daily. intervention 2: Participants will receive gemcitabine as 1000 milligrams per meter-squared (mg/m\^2) via intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.

Protocol documents:
Clinical trial NCT00607997
Conditions: Leukemia Acute Disease Acute Myeloid Leukemia Nonlymphocytic Leukemia Myelodysplastic Syndromes
Keywords: Leukemia Myeloid Elderly Hematologic Blood Cancer Malignancy SNS-595 Sunesis Hematologic Diseases Myelodysplastic Syndromes Older voreloxin reveal-1
Sponsor: Sunesis Pharmaceuticals
Start date: 2008-05-15; Completion date: 2009-11-23
Enrollment: 113 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the overall remission rate of treatment with vosaroxin (formerly voreloxin) Injection in patients at least 60 years of age with previously untreated AML

Detailed description:
Other objectives of this study include:

1. Assess the safety of treatment with vosaroxin, including the 30 and 60 day all-cause mortality
2. Assess leukemia free survival (LFS), event-free survival (EFS), overall survival (OS), and duration of remission (DR).
3. Characterize the pharmacokinetic (PK) profile of vosaroxin in this patient population.
4. Evaluate potential stratification biomarkers by evaluating DNA-damage and apoptotic pathways in bone marrow samples before and after treatment with vosaroxin

Arms: arm 1: * Schedule A: 72 mg/m2 vosaroxin Days 1, 8 and 15
* Schedule B: 72 mg/m2 vosaroxin on Days 1 and 8
* Schedule C: 72 mg/m2 on Days 1 and 4, or
* Schedule C: 90 mg/m2 on Days 1 and 4
Interventions: intervention 1: vosaroxin
Intervention descriptions: intervention 1: Vosaroxin was administered by slow intravenous (IV) infusion or via syringe pump within 10 minutes.Patients could have completed up to 4 treatment cycles consisting of 1 or 2 induction treatment cycles and up to 2 consolidation treatment cycles. For Schedule A, an induction cycle was a minimum of 21 days during which patients received vosaroxin on Days 1, 8, and 15, followed by weekly observations until hematologic recovery for patients with aplastic marrow after the postinduction bone marrow assessment. For Schedules B and C, an induction cycle was a minimum of 15 days, during which patients received vosaroxin on Days 1 and 8 (Schedule B), or Days 1 and 4 (Schedule C), followed by the same weekly observations until hematologic recovery as for Schedule A.

Protocol documents:
Clinical trial NCT00828854
Conditions: ER+ Breast Cancer
Keywords: breast cancer estrogen receptor positive
Sponsor: Syndax Pharmaceuticals
Start date: 2008-10-01; Completion date: 2009-11-24
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The addition of entinostat to an AI will result in a maximal abrogation of estrogen receptor-α mediated activity and inhibit mechanisms of resistance to the aromatase inhibitor.

It is hypothesized that entinostat with continued AI will increase the estimated AI clinical benefit rate (CBR) from 5% to 25% with an acceptable safety profile.

Detailed description:

Arms: arm 1: Entinostat 5 mg tablet orally every week on Days 1, 8. 15 and 22 of each 28-day treatment cycle in combination with continued treatment with AI therapy at labeled dose and schedule until disease progression or unacceptable toxicity.
Interventions: intervention 1: Entinostat intervention 2: Aromatase Inhibitor (AI) Therapy
Intervention descriptions: intervention 1: Entinostat 5 mg PO every week intervention 2: AI therapy at labeled dose and schedule as prescribed in clinical practice. AI therapies include: Arimidex® (anastrozole) 1 mg/day by mouth (PO), Fermara® (letrozole) 2.5 mg/day PO , Aromasin® (exemestane) 25 mg/day PO.

Protocol documents:
Clinical trial NCT00945282
Conditions: Infection, Human Immunodeficiency Virus
Keywords: IDX12899 adaptive monotherapy pharmacokinetics Treatment-naive HIV-1 GSK2248761 NNRTI HIV Infections treatment naive
Sponsor: ViiV Healthcare
Start date: 2009-10-20; Completion date: 2009-11-28
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
GSK has in-licensed a novel NNRTI-class candidate (GSK2248761, IDX12899) for the treatment of subjects with HIV-1 infection from Idenix Pharmaceuticals. Idenix Pharmaceuticals completed a proof-of-concept study evaluating GSK2248761 monotherapy over seven days in forty treatment-naïve subjects infected with HIV-1. GSK2248761 doses sequentially evaluated were 800 mg QD, 400 mg QD, 200 mg QD and 100mg QD.

This study will evaluate a lower dose, or doses, of GSK2248761 to better characterize the dose-response and concentration-response curves. The results from this study will be used to select doses for future clinical studies in HIV-1 infected subjects.

Detailed description:

Arms: arm 1: In Cohort 1 subjects will receive either GSK2248761 30 mg or placebo once a day for 7 days. On Day 8 subjects will receive either Kaletra or HAART for 28 days. The doctor will choose the most appropriate medications for HAART. arm 2: In Cohort 2 subjects will receive either GSK2248761 in the range of 10 mg - 20 mg or 40 mg - 90 mg or placebo once a day for 7 days. On Day 8 subjects will receive either Kaletra or HAART for 28 days. The doctor will choose the most appropriate medications for HAART. The dose for Cohort 2 will be determined following evaluation of results from Cohort 1. Cohort 2 may not be done.
Interventions: intervention 1: GSK2248761 intervention 2: Lopinavir/ritonavir intervention 3: HAART intervention 4: Placebo intervention 5: GSK2248761
Intervention descriptions: intervention 1: GSK2248761 30 mg capsule once a day for 7 days. GSK2248761 is an investigational (not approved by the FDA) HIV drug in the class of non-nucleoside reuptake inhibitor class. intervention 2: Lopinavir 400 mg and ritonovir 100 mg every 12 hours for 28 days. Lopinavir/ritonavir is approved by the FDA as an HIV medication in the protease inhibitor class. Kaletra is a trademark of Abbott Laboratories. intervention 3: Highly Active Antiretroviral therapy of the doctor's choice. intervention 4: Placebo is a capsule with no drug in it. intervention 5: GSK2248761 10 mg -20 mg or 40 mg - 90 mg once a day for 7 days. GSK2248761 is an investigational (not approved by the FDA) HIV drug in the class of non-nucleoside reuptake inhibitor class.

Protocol documents:
Clinical trial NCT00725712
Conditions: Neoplasms, Gastrointestinal Tract
Keywords: c-Met Metastatic Gastric Carcinoma adenocarcinoma Gastric cancer GSK1363089 XL880 MET inhibitor
Sponsor: GlaxoSmithKline
Start date: 2007-03-31; Completion date: 2009-11-30
Enrollment: 74 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical study is being conducted at multiple sites to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in metastatic gastric carcinoma.

Detailed description:

Arms: arm 1: Dosing for first 5 days in every 14-day period. arm 2: dosed every day
Interventions: intervention 1: GSK1363089 (formerly XL880)
Intervention descriptions: intervention 1: c-MET tyrosine kinase inhibitor

Protocol documents:
Clinical trial NCT00455533
Conditions: Breast Cancer
Keywords: Early Breast Cancer
Sponsor: Bristol-Myers Squibb
Start date: 2007-10-01; Completion date: 2009-12-01
Enrollment: 384 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the effectiveness of ixabepilone when given after doxorubicin plus cyclophosphamide (AC) compared to standard treatment of paclitaxel given after doxorubicin plus cyclophosphamide in patients with early stage breast cancer. In addition the study will verify predefined biomarkers as well as discover new biomarkers that could identify patients who are more likely to respond to ixabepilone than standard paclitaxel based therapy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ixabepilone intervention 2: Paclitaxel intervention 3: Cyclophosphamide intervention 4: Doxorubicin
Intervention descriptions: intervention 1: Intravenous Solution, intravenous (IV), 40mg/m², Day 1 every 21 days, 12 Weeks intervention 2: Intravenous Solution, IV, 80mg/m², Weekly, 12 Weeks intervention 3: Intravenous Solution, IV, 600mg/m², Day 1 every 21 days, 12 Weeks intervention 4: Intravenous Solution, IV, 60mg/m², Day 1 every 21 days, 12 Weeks

Protocol documents:
Clinical trial NCT00549198
Conditions: Infection, Human Immunodeficiency Virus I HIV Infection
Keywords: tenofovir HIV efavirenz naive lamivudine abacavir emtricitabine renal
Sponsor: GlaxoSmithKline
Start date: 2007-06-01; Completion date: 2009-12-01
Enrollment: 392 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Recently, the fixed-dose combinations (FDC) KIVEXA™ (abacavir/lamivudine) and TRUVADA (tenofovir disoproxil fumarate/emtricitabine) have facilitated the usage of once-daily regimens. However data from head-to-head randomized trials comparing these two FDCs as part of an initial regimen are not available at present. The long-term toxicity profiles of these regimens are of particular importance, as treatment of HIV is currently life-long and therefore, minimizing long-term toxicity and maximizing adherence and duration of regimen maintenance are critical therapy objectives.

The primary endpoint is estimated glomerular filtration rate (GFR), as measured by the modified diet in renal disease (MDRD) equation, a validated estimate of renal function.

Detailed description:
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Abacavir/lamivudine and efavirenz intervention 2: Tenofovir/Emtricitabine and efavirenz
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: