ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01453049
Conditions: Diabetes Mellitus, Type 2
Keywords: rosiglitazone/glimepiride, fix dose, type 2 diabetes
Sponsor: GlaxoSmithKline
Start date: 2010-04-01; Completion date: 2010-10-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate that the rosiglitazone/glimepiride fixed-dose combination tablet will safely and effectively control glycemia as first-line oral therapy in drug naïve subjects with type 2 diabetes. This 24-week study will compare the effects of treatment with rosiglitazone/glimepiride to treatment with glimepiride alone. The primary objective is to demonstrate superiority of rosiglitazone/glimepiride to glimepiride in lowering Glycosylated Hemoglobin (HbA1c).

Detailed description:
The antihyperglycemic effect of the thiazolidinedione (TZD) class of oral antidiabetic agents is due to their ability to increase insulin sensitivity at the cellular level, which in turn improves the ability of endogenous insulin to regulate glucose utilization by the tissues. Compounds of the sulfonylurea (SU) class act to stimulate insulin production by the pancreas, overcoming insulin resistance by increasing circulating insulin levels. The mechanisms of two kind OADs may be viewed as complementary, offering the opportunity for improved efficacy and durability of effect through coadministration of a TZD and a sulfonylurea.

Successful management of type 2 diabetes mellitus (T2DM) requires aggressive glycemic control starting at the earliest stages of the disease. Rosiglitazone/glimepiride combination therapy, with complementary mechanisms of action, has the potential to provide significant benefits over monotherapy as first line therapy. Treatment with rosiglitazone/glimepiride at this early stage of diabetes is expected to provide better glycemic control and allow a greater proportion of patients to achieve target glycemic goals than oral monotherapy.

This was a multicenter, randomized, double-blinded, parallel, study to compare the effects of treatment with rosiglitazone/glimepiride combination or glimepiride in drug naïve T2 DM patients.

Arms: arm 1: 4mg/1mg, 4mg/2mg, 4mg/4mg arm 2: 1mg, 2mg, 4mg
Interventions: intervention 1: rosiglitazone/glimepiride fix dose combination intervention 2: glimepiride
Intervention descriptions: intervention 1: oral, once daily, dosage is titrated according to FPG and hypoglycemia events intervention 2: oral, once daily, dosage is titrated according to FPG and hypoglycemia

Protocol documents:
Clinical trial NCT01562743
Conditions: Idiopathic Restless Legs Syndrome
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2008-08-01; Completion date: 2010-10-01
Enrollment: 185 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aims of the trial are to assess the safety and the efficacy of SPM 962 following once-a-daily transdermal administration within a range of 2.25 to 6.75 mg/day in Japanese patients with restless legs syndrome (RLS) in a multi-center, open-label trial. The maximum treatment period is 53 weeks. The trial is an extension trial from the precedent 6-week, double-blind, randomized, placebo-controlled, parallel-group comparative trial(243-07-003). The trial is also for an exploratory investigation of incidence of augmentation, the most problematic complications in dopaminergic treatment.

Detailed description:

Arms: arm 1: Rotigotine transdermal patch
Interventions: intervention 1: SPM 962
Intervention descriptions: intervention 1: Tansdermal patch

Protocol documents:
Clinical trial NCT01628965
Conditions: Parkinson's Disease
Keywords: SPM 962 rotigotine Parkinson's disease monotherapy
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2008-01-01; Completion date: 2010-10-01
Enrollment: 143 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Safety of SPM 962 in a once-daily repeated long-term treatment in Parkinson's disease patients who are not concomitantly treated with L-dopa will be investigated with a doses.

Detailed description:

Arms: arm 1: SPM 962 transdermal patch
Interventions: intervention 1: SPM 962
Intervention descriptions: intervention 1: SPM 962 transdermal patch once a daily up to 36.0 mg/day

Protocol documents:
Clinical trial NCT02013206
Conditions: Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2006-09-01; Completion date: 2010-10-01
Enrollment: 52 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of Tarceva in two groups of patients with non-small cell lung cancer who have not been pre-treated with chemotherapy. One group, consisting of patients who have never smoked, will receive Tarceva 150 mg/day, and the other group, consisting of current/former smokers, will receive Tarceva 150 mg/day increasing to a maximum of 300 mg/day. The anticipated time on study treatment is 1-2 years.

Detailed description:

Arms: arm 1: Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib \[Tarceva\] 150 mg orally daily until disease progression or unacceptable toxicity. arm 2: Current Smokers (participants who smoked \> 100 cigarettes in entire lifetime and either quit smoking \< 1 year ago or were currently smoking) or Former Smokers (participants who smoked \> 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib \[Tarceva\] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
Interventions: intervention 1: erlotinib [Tarceva]
Intervention descriptions: intervention 1: Erlotinib tablets taken orally once daily in the morning.

Protocol documents:
Clinical trial NCT02578316
Conditions: Advanced Solid Tumors Lymphomas
Keywords: Advanced Solid Tumors Lymphomas
Sponsor: Eisai Inc.
Start date: 2009-06-01; Completion date: 2010-10-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to determine the metabolism and elimination of 14C-lenvatinib in participants with advanced solid tumors or lymphomas, who were unsuitable for, or had failed, existing therapies.

Detailed description:
The study comprised of two phases, the Study Phase and Extension Phase. Participants received 14C-lenvatinib on Day 1 of the Study Phase. Thereafter participants were given daily oral doses of 24 mg of lenvatinib over a 28 day cycle. During the Study Phase, participants received an initial single dose of 14C-lenvatinib oral patient dosing solution containing 24 mg of lenvatinib as anhydrous free base and radioactivity of 100 mCi (3.7 MBq) on Day 1, followed by collection of blood, urine and feces samples for pharmacokinetic analysis between Day 1 and Day 8, with a discharge visit on Day 8. Participants then entered the Extension Phase of the study to continue to receive once daily oral administration of non-radiolabeled lenvatinib at a dose of 24 mg. Each 28-day dosing period will be considered one treatment cycle.

Arms: arm 1: Participants with advanced solid tumors or lymphomas, who are unsuitable for, or had failed, existing therapies.
Interventions: intervention 1: Lenvatinib
Intervention descriptions: intervention 1: Study phase dosing: participants received an initial single dose of radiolabelled 14C-lenvatinib oral patient dosing solution containing 24 mg of lenvatinib as anhydrous free base and radioactivity of 3.7 millibecquerel (MBq) on Day 1.

Extension phase dosing: 24 mg of 14C-lenvatinib: 2 x 10mg, and 4 x 1mg or 1 x 4mg tablets once-daily, continuously in each 28-day cycle during extension phase.

Protocol documents:
Clinical trial NCT00972725
Conditions: AIDS
Keywords: Chloroquine Human Immunodeficiency Virus
Sponsor: GlaxoSmithKline
Start date: 2009-12-01; Completion date: 2010-10-04
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and reactogenicity of one booster dose of a HIV candidate vaccine after administration of one oral dose of chloroquine.

Detailed description:
The Protocol Posting has been updated following Protocol amendment 1, October 2009.

Arms: arm 1: Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine. arm 2: Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Interventions: intervention 1: GSK Biologicals' HIV vaccine (732461) intervention 2: Chloroquine
Intervention descriptions: intervention 1: 1 dose intramuscular injection intervention 2: One dose of 300 mg

Protocol documents:
Clinical trial NCT01034111
Conditions: Type 2 Diabetes
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-03-01; Completion date: 2010-10-04
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess, over a 4-week treatment period, the safety and efficacy of the addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who failed to achieve glycemic control on metformin monotherapy.

Detailed description:

Arms: arm 1: Sitagliptin as add-on therapy to a stable dose of metformin
Interventions: intervention 1: Sitagliptin phosphate intervention 2: Metformin
Intervention descriptions: intervention 1: Sitagliptin 100 mg tablet by mouth once daily for 4 weeks. intervention 2: Stable dose of metformin tablet(s) by mouth (at least 1000 mg/day) for 4 weeks.

Protocol documents:
Clinical trial NCT00568126
Conditions: Antidepressant Induced Sexual Dysfunction
Keywords: Antidepressant Induced Sexual Dysfunction Depression Sexual Dysfunction
Sponsor: Massachusetts General Hospital
Start date: 2007-12-27; Completion date: 2010-10-05
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out whether Maca Root is effective for treating sexual dysfunction in females that is caused by antidepressant drugs. An additional aim of the study is to document the safety and tolerability of maca root, as well as any potential side effects that it causes.

Detailed description:
This is a 12-week, double-blind, placebo-controlled trial comparing maca root (3.0 g/day) versus an inactive placebo in female outpatients with SSRI/SNRI-induced sexual dysfunction whose depression had remitted with SSRI treatment. Outcome measures include improvement in sexual functioning as per the Arizona Sexual Experience Scale (ASEX) and the Massachusetts General Hospital Sexual Function Questionnaire (MGH-SFQ).

Arms: arm 1: Subjects in this arm will be given 3g/day of maca root for 12 weeks arm 2: Subjects in this arm will receive inactive placebo for 12 weeks.
Interventions: intervention 1: Maca Root intervention 2: Placebo
Intervention descriptions: intervention 1: 3g/day of Maca Root for 12 weeks. intervention 2: Placebo provided by research pharmacy daily for 12 weeks.

Protocol documents:
Clinical trial NCT00997984
Conditions: Attention-Deficit/Hyperactivity Disorder
Keywords: ADHD
Sponsor: Shire
Start date: 2009-11-17; Completion date: 2010-10-09
Enrollment: 340 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose is to assess the efficacy of once daily dosing with optimized SPD503 (1, 2, 3 and 4mg/day), dosed either in the morning or evening, compared to placebo, in children with ADHD as measured by change from baseline score at endpoint on the ADHD-RS-IV.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: extended-release guanfacine hydrochloride (SPD503) intervention 2: placebo intervention 3: extended-release guanfacine hydrochloride
Intervention descriptions: intervention 1: dosed in AM intervention 2: dosed in the AM or PM intervention 3: Dosed in the PM

Protocol documents:
Clinical trial NCT00266799
Conditions: Breast Cancer
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-01-13; Completion date: 2010-10-18
Enrollment: 210 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label, multinational, randomized, multicenter trial designed to compare pegylated liposomal doxorubicin with capecitabine as first line chemotherapy of metastatic breast cancer. The primary objective of the study is to compare the time to disease progression, although overall response rates, overall survival, quality of life, time to treatment failure, and safety and tolerability will also be assessed.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pegylated liposomal doxorubicin (SCH 200746) intervention 2: Capecitabine
Intervention descriptions: intervention 1: pegylated liposomal doxorubicin (50 mg/m\^2 q 28 days) was administered intravenously until disease progression or unacceptable toxicity intervention 2: capecitabine (1250 mg/m\^2 BID x 14 days q 21 days) in tablets of 150 mg and 500 mg was administered orally, until disease progression or unacceptable toxicity

Protocol documents:
Clinical trial NCT01052493
Conditions: Obesity
Keywords: obesity pancreatic polypeptide gut hormones
Sponsor: Imperial College London
Start date: 2010-04-01; Completion date: 2010-10-18
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
When humans eat, the bowels naturally secrete chemicals into the bloodstream which make people feel full and which stop eating. One of these chemicals is known as "Pancreatic Polypeptide" (PP). We have previously shown that injections of human PP reduces appetite and food intake. We have now developed a very similar chemical, PP 1420, as a treatment for obesity. PP 1420 has been tested in animals and has been shown to be safe, and to reduce their appetite. This study will test PP 1420 for its safety and tolerability in humans.

Detailed description:
More than 20 percent of people in the UK are obese. People with obesity have a shorter life expectancy, and have a higher risk of having heart attacks, strokes, high blood pressure, diabetes, and certain cancers.

At the moment, there is no treatment for obesity that is both effective and safe. Advising people to change their diet and to exercise more is frequently ineffective, and any loss in weight seen is usually temporary. There are a couple of licensed medications for the purpose of losing weight, but they are limited by side effects. Finally, gastric bypass and similar surgeries are effective at reducing weight permanently, but it can be risky and is restricted only to very motivated people.

"Gut hormones" are natural chemicals made by the bowels when you eat. They work to reduce appetite and hunger when you eat, so that you will eat enough for your needs. We think that one of the reasons why gastric bypass surgery is so effective is because the surgery causes an increase in gut hormone secretion into the bloodstream, which suppresses appetite. One of these hormones is pancreatic polypeptide (PP), which is released into the bloodstream by cells in the pancreas after eating. When human PP is given to healthy volunteers as an injection, we see that they have a reduced appetite and food intake with no side effects such as feeling sick or vomiting.

Human PP does not last long in the blood stream. In order to make it into a new, safe and effective drug for obesity, we have developed a new form of PP, which is very similar but not identical to human PP, that we expect will last longer in the blood. We call this PP 1420.

In testing, PP 1420 reduced food intake in animals, and was safe in them at much higher doses than those we plan to give in the current study. This study will assess the safety and tolerability of PP 1420 in humans, and is the first time humans have been given this medication.

Arms: arm 1: PP 1420 single dose, subcutaneous arm 2: PP 1420 single dose, subcutaneous arm 3: PP 1420 single dose, subcutaneous arm 4: 0.9% saline
Interventions: intervention 1: PP 1420 intervention 2: Placebo
Intervention descriptions: intervention 1: Single dose of PP 1420, administered subcutaneously at either 2mg, 4mg or 8mg. intervention 2: 0.9% saline

Protocol documents:
Clinical trial NCT00699972
Conditions: Refractory Partial Seizures
Keywords: E2007 perampanel refractory partial seizures adjunctive therapy seizure frequency partial onset seizures reduction in seizure frequency safety concomitant AED(s)
Sponsor: Eisai Inc.
Start date: 2008-04-30; Completion date: 2010-10-19
Enrollment: 390 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, efficacy and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: E2007 (perampanel) intervention 2: E2007 (perampanel) intervention 3: Placebo
Intervention descriptions: intervention 1: 8 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose. intervention 2: 12 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose. intervention 3: Placebo in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study.

Protocol documents:
Clinical trial NCT00093964
Conditions: Glioblastoma Multiforme
Keywords: Brain cancer Brain tumor
Sponsor: EMD Serono
Start date: 2004-10-13; Completion date: 2010-10-21
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate clinical activity, safety, and tolerability of the anti-angiogenic compound cilengitide (EMD 121974) in the treatment of first recurrence of glioblastoma multiforme (GBM).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Cilengitide 500 mg intervention 2: Cilengitide 2000 mg
Intervention descriptions: intervention 1: Subjects will receive 1-hour intravenous infusion of 500 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent. intervention 2: Subjects will receive 1-hour intravenous infusion of 2000 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.

Protocol documents:
Clinical trial NCT00686829
Conditions: HIV HIV Infections
Keywords: Treatment Experienced
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-06-30; Completion date: 2010-10-21
Enrollment: 79 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to provide open-label vicriviroc (VCV) to human immunodeficiency virus (HIV) treatment-experienced participants who successfully completed 48 weeks of treatment on Acquired Immunodeficiency Syndrome (AIDS) Clinical Trial Group (ACTG) protocol A5211 (or who responded favorably to treatment but discontinued participation due to viral tropism shifts), and participants who screened for ACTG A5211 and met all inclusion/exclusion criteria, but were unable to enroll due to protocol closure.

Detailed description:

Arms: arm 1: Participants take VCV 30 mg once daily.
Interventions: intervention 1: Vicriviroc maleate
Intervention descriptions: intervention 1: VCV 30 mg tablet once daily by mouth.

Protocol documents:
Clinical trial NCT00681811
Conditions: Late Infantile Metachromatic Leukodystrophy
Keywords: Metazyme Late Infantile Metachromatic Leukodystrophy
Sponsor: Shire
Start date: 2008-02-20; Completion date: 2010-10-22
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, open-label, extension study of patients with late infantile MLD who have previously completed clinical study HGT-MLD-048 (NCT00633139), defined as the completion of all Week 52 procedures. This group of patients will be offered ongoing treatment with HGT-1111 in this protocol. One infusion will be given every other week until the product is commercially available, the patient discontinues, or the study is terminated by the Sponsor, provided no safety issues have emerged.

Detailed description:
The primary objective of this study is to provide ongoing treatment of HGT-1111 to patients who have completed study HGT-MLD-048 (previously study rhASA-03 - NCT00633139) until HGT-1111 is commercially available or the study is terminated by the Sponsor, provided no safety concerns have emerged. The secondary objective of this study is to monitor disease progression and the safety profile of HGT-1111 administered to patients who have completed study HGT-MLD-048 (NCT00633139).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: HGT-1111
Intervention descriptions: intervention 1: Patients currently dosed with 100 U/kg or 200 U/kg will continue this treatment. Patients dosed with 50 U/kg will be equally randomized to treatment on 100 U/kg or 200 U/kg. The dose will be adjusted every 6-week to account for changes in body weight.The infusion length will be dependent on the dose. Infusion of 100 U/kg will be diluted in 50 ml isotonic sodium chloride and infused over 30 minutes. Infusion of 200 U/kg will be administered in the same manner except for an infusion time of 60 minutes.

Protocol documents:
Clinical trial NCT01183234
Conditions: ADHD
Sponsor: Shire
Start date: 2010-08-27; Completion date: 2010-10-22
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess bioequivalence of 2 capsule strengths.

Detailed description:
This will be a randomised, open-label, two-period, single dose, crossover bioequivalence study in healthy subjects under fasting conditions to assess bioequivalence of 1 x 60 mg capsule methylphenidate compared to 2 x 30 mg capsules methylphenidate. Pharmacokinetics and safety will be assessed.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: SPD544 intervention 2: Methylphenidate hydrochloride
Intervention descriptions: intervention 1: two 30mg capsules, single oral dose intervention 2: one 60mg capsule, single oral dose

Protocol documents: