ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01130051
Conditions: Healthy
Keywords: bioavailability
Sponsor: Mutual Pharmaceutical Company, Inc.
Start date: 2010-05-01; Completion date: 2010-06-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and sprinkled on applesauce (1 tablespoon) relative to the same dose given as an intact tablet to healthy subjects following an overnight fast. A secondary objective is to evaluate the safety and tolerability of this regimen in healthy volunteers. All study subjects will be monitored for adverse events throughout the study period.

Detailed description:
The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and sprinkled on applesauce (1 tablespoon) relative to the same dose given as an intact tablet to healthy subjects following an overnight fast. Sixteen healthy, non-smoking, non-obese, male and female volunteers between 18-55 years of age will be randomly assigned in a crossover fashion to receive each of two dosing regimens in sequence with a 14 day washout period between dosing periods. In each of the dosing periods, after an overnight fast, subjects will receive one intact Colcrys® 0.6 mg tablet (followed by 240 mL of water) or one Colcrys® 0.6 mg tablet crushed and sprinkled on 1 tablespoon of applesauce (followed by 240 ml of water) according to the randomization schedule. Blood samples will be drawn from all participants before dosing and for 48 hours post-dose at times sufficient to adequately define the pharmacokinetics of colchicine. Vital signs (blood pressure, heart rate, respiratory rate and temperature) will be measured prior to dosing, 1 hour ± 30 minutes post-dose and upon discharge from the clinical facility. Subjects will be monitored throughout their participation in the study for adverse reactions.

Arms: arm 1: One Colcrys® 0.6 mg intact tablet taken by mouth arm 2: One Colcrys® 0.6 mg tablet crushed and sprinkled on applesauce
Interventions: intervention 1: Colchicine 0.6 mg tablet intervention 2: Colchicine 0.6 mg tablet
Intervention descriptions: intervention 1: One Colcrys® 0.6 mg intact tablet taken by mouth intervention 2: One Colcrys® 0.6 mg tablet crushed and sprinkled on applesauce

Protocol documents:
Clinical trial NCT01133860
Conditions: Blood Platelet Disorders
Keywords: inherited thrombocytopenia MYH9 mutations eltrombopag
Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Start date: 2009-01-01; Completion date: 2010-06-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The term MYH9-related disease (MYH9RD) includes four genetic disorders: May-Hegglin anomaly, Sebastian syndrome, Fechtner syndrome, and Epstein syndrome. All these disorders derive from mutation of a unique gene, named MYH9, and they have been recognized as different clinical presentations of a single illness that was named MYH9RD. All patients affected by MYH9RD present since birth with thrombocytopenia, which can result in a variable degree of bleeding diathesis; some of them subsequently develop additional clinical manifestations, such as renal damage, sensorineural hearing loss, and/or presenile cataracts. Eltrombopag is an oral thrombopoietin receptor agonist that stimulates proliferation and differentiation of megakaryocytes, the bone marrow cells that produce blood platelets. This drug is effective in increasing platelet count in healthy volunteers, as well as in patients affected by some acquired thrombocytopenias, such as idiopathic thrombocytopenic purpura and HCV related thrombocytopenia. The purpose of this study is to determine if eltrombopag, administered orally at the dose of 50 or 75 mg/daily for up to 6 weeks, is effective in increasing platelet count of patients affected by MYH9RD. Further aims of this study are to test if eltrombopag is effective in reducing bleeding tendency of MYH9RD patients; to evaluate safety and tolerability of eltrombopag in patients with MYH9RD; to evaluate in vitro function of platelets produced during therapy in patients responding to this drug.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: eltrombopag
Intervention descriptions: intervention 1: Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 will continue eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 will receive eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 will stop therapy.

Protocol documents:
Clinical trial NCT01138826
Conditions: Healthy Volunteers
Keywords: biological availability bioavailability amlodipine orally disintegrating tablet ODT tablets
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2010-05-01; Completion date: 2010-06-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine besylate (non-ODT) tablet.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Amlodipine - reference intervention 2: Amlodipine ODT - test intervention 3: Amlodipine ODT - test
Intervention descriptions: intervention 1: 10 mg tablet, single dose, with water intervention 2: 10 mg orally disintegrating tablet (ODT), single dose, with water intervention 3: 10 mg orally disintegrating tablet (ODT), single dose, without water

Protocol documents:
Clinical trial NCT01139008
Conditions: Skin Manifestations
Sponsor: Galderma R&D
Start date: 2010-06-01; Completion date: 2010-06-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the tolerability of MetroGel® (metronidazole gel) 1% to Finacea® (azelaic acid) Gel 15% in subjects with healthy skin applied according to product labeling for three weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: metronidazole 1% gel intervention 2: azelaic acid 15% gel
Intervention descriptions: intervention 1: Apply topically on one side of the face once daily for three weeks intervention 2: Apply topically on the opposite side of the face twice daily for three weeks

Protocol documents:
Clinical trial NCT01139047
Conditions: Skin Manifestations
Sponsor: Galderma R&D
Start date: 2010-06-01; Completion date: 2010-06-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the tolerability of MetroGel® 1% to Finacea® 15% in subjects with healthy skin applied according to product labeling for three weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: metronidazole 1% gel intervention 2: azelaic acid 15% gel
Intervention descriptions: intervention 1: Apply topically once daily on one side of the face for three weeks intervention 2: Apply topically twice daily on the opposite side of the face for three weeks

Protocol documents:
Clinical trial NCT01143051
Conditions: Asthma
Keywords: Asthma Pharmacokinetics Epinephrine Bronchodilator metered dose inhaler
Sponsor: Amphastar Pharmaceuticals, Inc.
Start date: 2010-01-01; Completion date: 2010-06-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), in healthy male and female adult volunteers. Safety of E004 will also be evaluated, under augmented dose conditions.

Detailed description:
This study is a randomized, evaluator-blind, single dose, three-arm, crossover, PK study, to be conducted in \~18 healthy, male and female, adult volunteers. PK will be studied at two dose strengths (Arm T1 and Arm T2). A currently marketed, non-labeled, Epinephrine CFC-MDI will be used as a Reference Control (Arm C).

* At the Screening Visit and the beginning of each Study Visit, each subject will be trained on the correct self-administration of MDI. The following three randomized treatments will be self-administered, at three Study Visits:

  * Treatment T1: Ten (10) inhalations of the low dose E004(125 mcg/inhalation), totaling 1.25 mg of epinephrine;
  * Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine;
  * Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation, totaling 2.2 mg of epinephrine base equivalent).
* PK blood samples will be taken from a vein at scheduled time points.
* Safety parameters and adverse drug events, if any, will be monitored and documented at each study visit. An End-of-Study (EOS) safety evaluation will be conducted.

Arms: arm 1: Active comparator arm utilizing marketed Primatene Mist with CFC propellant at the labeled dose. arm 2: T1 is HFA propelled epinephrine inhalation aerosol 125 mcg/inhalation arm 3: HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation
Interventions: intervention 1: epinephrine inhalation aerosol intervention 2: epinephrine inhalation aerosol intervention 3: epinephrine inhalation aerosol
Intervention descriptions: intervention 1: Single dose 220 mcg/inhalation, 10 inhalations intervention 2: HFA propelled epinephrine inhalation aerosol, 125 mcg/inhalation, 10 inhalations intervention 3: HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation, 10 inhalations

Protocol documents:
Clinical trial NCT01177293
Conditions: Healthy Volunteers
Keywords: biological availability bioavailability amlodipine orally disintegrating tablet ODT tablets
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2010-03-01; Completion date: 2010-06-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine besylate capsule.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Amlodipine - reference intervention 2: Amlodipine ODT - test
Intervention descriptions: intervention 1: Amlodipine capsule, 10 mg, single dose, with water intervention 2: Amlodipine orally disintegrating tablet (ODT), 10 mg, single dose, without water

Protocol documents:
Clinical trial NCT01224431
Conditions: Pain
Keywords: pain lidocaine lumbar puncture j-tip
Sponsor: Phoenix Children's Hospital
Start date: 2009-06-01; Completion date: 2010-06-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Background: The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered lidocaine. This study compares needle-free jet injection of lidocaine to saline in reducing pain prior to lumbar puncture in infants.

Methods: Randomized, double-blinded, placebo controlled trial involving infants, less than 3 months of age, presenting to the emergency department meeting clinical criteria for a lumbar puncture. All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture.

Detailed description:
Background: Lumbar puncture is an essential procedure in the emergency department for the evaluation of meningitis. Subcutaneous injection of lidocaine prior to lumbar puncture for local anesthesia is not a pain free procedure. The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered lidocaine. This study compares needle-free jet injection of lidocaine to saline in reducing pain prior to lumbar puncture in infants.

Methods: Randomized, double-blinded, placebo controlled trial involving infants, less than 3 months of age, presenting to the emergency department meeting clinical criteria for a lumbar puncture. All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture. Vital signs were recorded during the procedure. Facial expressions as well as crying times were video recorded from start to finish. Independent reviewers assigned pain scores based on the validated Neonatal Facial Coding System with possible scores ranging from 0-5.

Arms: arm 1: Needleless injection of buffered lidocaine prior to lumbar puncture versus placebo (Normal saline) arm 2: Needleless injection of normal saline (placebo) prior to lumbar puncture versus use of buffered lidocaine
Interventions: intervention 1: Buffered Lidocaine J-tip
Intervention descriptions: intervention 1: All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture. Vital signs were recorded during the procedure. Facial expressions were video recorded

Protocol documents:
Clinical trial NCT01242644
Conditions: Pain
Sponsor: University of South Alabama
Start date: 2006-10-01; Completion date: 2010-06-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Hypothesis: Ropivacaine, morphine and ketorolac injected after knee arthroscopy is as effective as this solution plus ropivacaine administered intra-articularly for twenty-four hours.

Three groups were assigned random patients, each group provided a different method of pain medication in order to determine the effectiveness of each treatment.

Detailed description:
Arthroscopic knee patients were randomized to 1 of 3 groups. A) 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; B) an identical solution plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour; C) an identical solution and no pain pump. Pain level, the amount of pain medication used and time to discharge were recorded. Clinical and radiographic evaluation was performed at nine months after surgery.

Arms: arm 1: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; arm 2: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour arm 3: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump.
Interventions: intervention 1: pain pump containing ropivacaine intervention 2: saline pain pump with injectable medication intervention 3: ropivacaine, ketorolac , morphine sulfate
Intervention descriptions: intervention 1: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour intervention 2: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour intervention 3: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected

Protocol documents:
Clinical trial NCT01345786
Conditions: Healthy Postmenopausal Females
Sponsor: Organon and Co
Start date: 2009-11-01; Completion date: 2010-06-01
Enrollment: 158 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
For the contraceptive application a film-coated tablet has been developed which combines nomegestrol acetate (NOMAC) with estradiol (E2). This was an open-label, randomized, single-dose, four-way, replicate, cross-over study design conducted in 2 parallel parts at two sites, one site per study part. The primary objective of Part 1 was to assess the bioequivalence of NOMAC and E2 of the drug product manufactured using the commercial process ("commercial batch") versus the Phase 3 drug product ("Batch A"). The primary objective of Part 2 was to assess bioequivalence of NOMAC and E2 of the drug product manufactured using the commercial process ("commercial batch") versus the Phase 3 drug product ("Batch B").

Detailed description:

Arms: arm 1: Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from "Site 1". arm 2: Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program ("Batch A"), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from "Site 1". arm 3: Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from "Site 2". arm 4: Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program ("Batch B"), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from "Site 2".
Interventions: intervention 1: Commercial NOMAC-E2 intervention 2: Phase 3 NOMAC-E2 "Batch A" intervention 3: Phase 3 NOMAC-E2 "Batch B"
Intervention descriptions: intervention 1: 1 x 2.5 mg NOMAC/1.5 mg E2 fixed dose combination commercial tablet orally in the morning on Day 1 for all periods intervention 2: 1 x 2.5 mg NOMAC/1.5 mg E2 fixed dose combination tablet from the Phase 3 clinical trial program ("Batch A") orally in the morning on Day 1 for all periods intervention 3: 1 x 2.5 mg NOMAC/1.5 mg E2 fixed dose combination tablet from the Phase 3 clinical trial program ("Batch B") orally in the morning on Day 1 for all periods

Protocol documents:
Clinical trial NCT01515540
Conditions: Low Back Pain
Keywords: chronic back pain placebo fmri brain imaging
Sponsor: Northwestern University
Start date: 2004-01-01; Completion date: 2010-06-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators tested whether pain decrease can be observed centrally with non-invasive brain imaging in CBP subjects receiving Lidoderm. The investigators first tested effects of 5% Lidoderm patched in an open labelled trial. Next the investigators compared the effects of Lidocaine versus Placebo patches. Three time points were evaluated: baseline (before treatment) and 6 hours and 2 weeks after treatment. The latter trial was a 2 arm, double blind, placebo controlled trial, where participants either received Lidoderm or placebo patches, without cross over.

Detailed description:
Previous data showed that Lidoderm patches that contain 5% Lidocaine applied to the affected area for a period of 1-2 weeks decreased chronic pain. We conducted a preliminary open-label trial in chronic back pain patients and found that the patients reported reduction in pain intensity and associated brain activity (measured with fMRI). As a next step, we conducted a double blind clinical trial where the drug was tested against placebo to determine whether the effects on CBP were mediated by a pharmacological mechanism. For this we obtained psychophysical measurements of pain and measures of brain activity using fMRI. Two scans after treatment (6 hour and 2 weeks after treatment) were conducted to observe the effects of short term and long term use.

Brain activity was measured by the non-invasive method of functional imaging (fMRI), which enables examination of cortical blood flow during pain rating. These brain scans were acquired in chronic back pain patients while they rated their ongoing chronic pain using a finger span device. In a control task, each patient also rated the changes in the length of a bar n a screen (a visual control task). Anatomical scans were also acquired.

The general design of the study was that CBP subjects were assesses with fmri for brain responses for ongoing pain at three time points. The initial (baseline) scan occurred after a minimum of 48 hour period during which the patients refrained from taking analgesic medication. The patients were next scanned at 6 hours after treatment and again after 2 weeks of continuous treatment. Subjects were randomised to placebo or Lidoderm (both Lidoderm and placebo patches were supplied by Endo Pharmaceuticals).

Arms: arm 1: 5% lidoderm patch arm 2: placebo patch
Interventions: intervention 1: lidocaine intervention 2: placebo
Intervention descriptions: intervention 1: 5% lidoderm patch intervention 2: placebo

Protocol documents:
Clinical trial NCT01568047
Conditions: Parkinson's Disease
Keywords: Parkinson Disease BIA 9-1067
Sponsor: Bial - Portela C S.A.
Start date: 2010-02-01; Completion date: 2010-06-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the tolerability and the effect of BIA 9-1067 at steady-state on the levodopa pharmacokinetics in Parkinson's Disease (PD) patients treated with levodopa/dopa-decarboxylase inhibitor.

Detailed description:
Multicentre, double-blind, randomised, placebo-controlled study in four parallel groups of PD patients treated with standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and with motor fluctuations ("wearing-off" phenomenon)

Arms: arm 1: PLC, Placebo

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half arm 2: 5 mg BIA 9-1067 (OPC, Opicapone)

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half arm 3: 15 mg BIA 9-1067 (OPC, Opicapone)

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half arm 4: 30 mg BIA 9-1067 (OPC, Opicapone)

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half
Interventions: intervention 1: Placebo intervention 2: BIA 9-1067 intervention 3: BIA 9-1067 intervention 4: BIA 9-1067 intervention 5: Levodopa/Carbidopa intervention 6: Levodopa/Benzerazide
Intervention descriptions: intervention 1: once-daily intervention 2: BIA 9-1067 - 5 mg single-dose intervention 3: BIA 9-1067 - 15 mg single-dose intervention 4: BIA 9-1067 - 30 mg single-dose intervention 5: Levodopa 100 mg Carbidopa 25 mg intervention 6: Levodopa 100 mg Benzerazide 25 mg

Protocol documents: