ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00695110
Conditions: Hypogonadism
Keywords: testosterone male hypogonadism low testosterone
Sponsor: Clarus Therapeutics, Inc.
Start date: 2008-06-01; Completion date: 2009-08-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this pharmacokinetic study is to determine whether oral testosterone (T) ester formulations can be used effectively to treat men with low testosterone.

Detailed description:
Determination of the steady-state serum T pharmacokinetic profiles for two oral formulations of T-esters \[testosterone undecanoate (TU) and TU combined with testosterone enanthate (TE)\] administered bis in die (BID) to 29 hypogonadal adult male subjects. TU was evaluated in total daily doses of 400 and 600 mg equivalents of T given twice daily for 7 or 8 days; TU + TE was evaluated in total daily doses of 600 and 800 mg equivalents of T given twice daily for 7 days. All subjects were enrolled into a single group and proceeded through the four Treatment Periods 1-4 in a sequential manner. In Treatment Period 3 the effect of food on the study-state pharmacokinetics profile of the TU formulation was evaluated.

Arms: arm 1: Treatment Period 1: Three capsules each containing 100 mg testosterone (T) as testosterone undecanoate (TU), twice daily (BID) for 7 days.

Treatment Period 2: Two capsules each containing 200 mg T as TU and testosterone enanthate (TE), BID for 7 days.

Treatment Period 3: Two capsules each containing 100 mg T as TU, BID for 8 days.

Treatment Period 4: Two capsules each containing 150 mg T as TU and TE, BID for 7 days.
Interventions: intervention 1: Oral testosterone undecanoate (TU) (300 mg T equivalents/dose) intervention 2: Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose) intervention 3: Oral testosterone undecanoate (TU) (200 mg T equivalents/dose with and without food) intervention 4: Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose)
Intervention descriptions: intervention 1: Three capsules each containing 100 mg testosterone (T) as TU, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods. intervention 2: Two capsules each containing 100 mg T as TU and 100 mg T as TE, BID. 400 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods. intervention 3: Two capsules each containing 100 mg T as TU, BID for 8 days. 200 mg T equivalents BID 30 minutes after initiation of meals (breakfast and dinner), except for Day 8 when the morning dose was administered fasting. A 7-14 day washout period occurred between successive Treatment Periods. intervention 4: Two capsules each containing 150 mg T as TU and 150 mg T as TE, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days.

Protocol documents:
Clinical trial NCT00702702
Conditions: Uterine Fibroids Anemia
Keywords: Uterine fibroids Anemia
Sponsor: Repros Therapeutics Inc.
Start date: 2008-06-01; Completion date: 2009-08-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.

Detailed description:
Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.

Study was terminated by clinical hold.

Arms: arm 1: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months arm 2: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months arm 3: Placebo, 2 capsules daily for 3 months
Interventions: intervention 1: Proellex 25 mg intervention 2: Proellex 50 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months intervention 2: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months intervention 3: Placebo, 2 capsules daily for 3 months

Protocol documents:
Clinical trial NCT00705653
Conditions: Cancer
Keywords: cancer advanced cancer solid tumors CGC-11047 PG-11047
Sponsor: Progen Pharmaceuticals
Start date: 2005-03-01; Completion date: 2009-08-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I study aims to assess the safety and tolerability of a new drug - PG-11047 - and to establish what happens to the drug once inside the body. An escalating dose of PG-11047 will be investigated in this study and the maximum tolerated dose of the drug will be established.

Detailed description:
This is an open-label phase I, dose-escalation safety study in subjects with refractory solid tumors. The primary objectives of the study are to assess the safety, tolerability, and pharmacokinetics of PG-11047. PG-11047 will be administered as a 60-minute intravenous infusion on days 1, 8 and 15 of each 28 day cycle. The planned minimum treatment schedule is 2 cycles (8 weeks) of PG-11047 treatment. Subjects who tolerate treatment may be eligible to receive additional cycles as per investigator's medical judgment. Evaluation of anti-tumor response will be performed every 2 cycles.

Arms: arm 1: None
Interventions: intervention 1: PG-11047
Intervention descriptions: intervention 1: PG-11047 will be administered as a 60-minute intravenous infusion on days 1, 8 and 15 of each 28 day cycle. A treatment cycle will be defined as 4 weeks of therapy. The planned minimum treatment schedule is 2 cycles of PG-11047 treatment (8 weeks).

Protocol documents:
Clinical trial NCT00706719
Conditions: Secondary Hypogonadism
Keywords: Adult Onset Idiopathic Hypothalamic Hypogonadism (AIHH) Secondary hypogonadism Semen volume Sperm count Sperm motility
Sponsor: Repros Therapeutics Inc.
Start date: 2008-06-01; Completion date: 2009-08-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone.

Detailed description:
The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone. A maximum of twelve subjects per group were randomized to daily treatments of Androxal® or topical testosterone (Testim®) for six months. The protocol was later amended to include a treatment group who received Androxal after a 3 month wash out period.

Arms: arm 1: 1 capsule daily for 6 months of 25 mg of Androxal in men without a 3 month wash out period arm 2: Testim 1% Gel applied topically for 6 months arm 3: 1 x 25 mg Androxal capsule daily for 6 months in men with a previous 3 month washout period of topical testosterone
Interventions: intervention 1: 25 mg Androxal intervention 2: Testim 1%
Intervention descriptions: intervention 1: 25 mg Androxal capsules, 1 capsule daily for 6 months intervention 2: Testim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months

Protocol documents:
Clinical trial NCT00708422
Conditions: Glaucoma Ocular Hypertension
Keywords: Ocular surface health OSDI TFBUT Glaucoma Ocular hypertension Corneal staining
Sponsor: Alcon Research
Start date: 2008-07-01; Completion date: 2009-08-01
Enrollment: 231 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this randomized, double-masked, parallel-group, multicenter study is to evaluate ocular surface effects after the administration of travoprost with SofZia® preservative system or Xalatan once daily for 12 weeks.

Detailed description:

Arms: arm 1: One drop self-administered in the study eye(s) once daily at night for 12 weeks arm 2: One drop self-administered in the study eye(s) once daily at night for 12 weeks
Interventions: intervention 1: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) intervention 2: Latanoprost ophthalmic solution 0.005% (XALATAN®)
Intervention descriptions: intervention 1: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as travoprost. intervention 2: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as latanoprost.

Protocol documents:
Clinical trial NCT00709956
Conditions: Pulmonary Arterial Hypertension
Keywords: Ventavis iloprost inhaled treatment pulmonary arterial hypertension
Sponsor: Actelion
Start date: 2008-07-01; Completion date: 2009-08-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Patients with symptomatic idiopathic pulmonary arterial hypertension (IPAH), or familial pulmonary arterial hypertension (FPAH) or pulmonary hypertension associated with Human immunodeficiency virus (HIV) or drugs/toxins in New York Heart Association (NYHA) functional class II to IV at baseline, naive to PAH treatment or currently being treated with a stable dose of either bosentan, ambrisentan or sildenafil will be enrolled in the PROWESS 15 study. This randomized, double blind, placebo-controlled, crossover, and single-dose study will determine whether a single inhaled dose of iloprost using the power 15 disc improves exercise capacity compared to placebo in patients with pulmonary arterial hypertension (PAH).

Detailed description:

Arms: arm 1: Single dose of iloprost (5 µg) on study day 2 followed by single dose of placebo on study day 3 arm 2: Single dose of placebo on study day 2 followed by single dose of iloprost (5 µg) on study day 3
Interventions: intervention 1: iloprost (5 µg) intervention 2: placebo
Intervention descriptions: intervention 1: Single dose of iloprost 5 µg using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc intervention 2: Single dose of matching placebo using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc

Protocol documents:
Clinical trial NCT00712166
Conditions: Cystic Fibrosis Lung Infection Pseudomonas Aeruginosa
Keywords: cystic fibrosis pseudomonas aeruginosa lung infection CFQ-R inhaled antibiotic aztreonam lysine
Sponsor: Gilead Sciences
Start date: 2008-05-01; Completion date: 2009-08-01
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second \[FEV1\] \>75% predicted, and Pseudomonas aeruginosa (PA) infection.

Detailed description:
CF patients often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a bacteria called Pseudomonas aeruginosa (PA). Treatment with antibiotics can stop or slow down the growth of the bacteria. The antibiotics may be given by mouth, intravenously (IV), or by inhalation as a mist. The purpose of this study was to evaluate the safety and efficacy of AZLI, an investigational formulation of the antibiotic aztreonam and administered three times a day using the PARI eFlow® electronic nebulizer, in CF patients with PA and mild lung disease.

In this study, participant eligibility was assessed at a screening visit that occurred up to 14 days prior to the baseline visit (Day 0). Those participants who met eligibility criteria at Day 0 were randomized and began a 28-day course of blinded study treatment (AZLI or placebo TID). Participants returned for clinic visits at Day 14, an end of treatment visit at Day 28, and a follow up visit 14 days after the last dose of the trial drug (Day 42).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AZLI 75 mg three times daily (TID) intervention 2: Placebo three times daily (TID)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00729469
Conditions: Atrophy Vaginal Diseases
Keywords: Vulvar and vaginal atrophy in postmenopausal women Menopausal symptoms Vaginal atrophy Urogenital atrophy
Sponsor: Shionogi
Start date: 2008-07-01; Completion date: 2009-08-01
Enrollment: 919 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.

Detailed description:

Arms: arm 1: Subjects will receive a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed. arm 2: Subjects will receive a single, oral dose (1 tablet) of Placebo each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed.
Interventions: intervention 1: Ospemifene 60 mg intervention 2: Placebo
Intervention descriptions: intervention 1: 60 mg/day oral dose of ospemifene for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed intervention 2: oral dose of placebo,1 tablet/day, for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed

Protocol documents:
Clinical trial NCT00732472
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease (COPD) Magnesium stearate GSK573719
Sponsor: GlaxoSmithKline
Start date: 2008-10-01; Completion date: 2009-08-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study drug which is an inhaled bronchodilator (lung airway relaxant)has been given to both healthy volunteers and to COPD patients before. This study will assess a new formulation of GSK573719. Many drugs are known to deteriorate over time. To make the study medicine less likely to deteriorate in its container, it is mixed with an inactive substance that helps to to maintain the quality of the study medicine. Previous studies have looked at GSK573719 with another inactive substance called Cellobiose Octaacetate (COA). This study will be looking at a new formulation of GSK573719 using Magnesium Stearate (MgSt) as the inactive substance. MgSt itself is not a medicine but is approved as a food ingredient and has also has been approved to be used in a number of marketed medical inhalers. The purpose of this study is to assess the safety and tolerability of compound GSK573719 with Magnesium Stearate for once-daily treatment of COPD(Chronic Obstructive Pulmonary Disease). This drug will be given to 2 groups of 12 people for 7 days. Group 1 will receive 250mcg or placebo and group 2 will receive 1000mcg or placebo. Group 2 will not be dosed until at least 6 people have completed dosing in group 1 without any significant safety concerns. The following safety measures will be assessed including: ECGs, heart rate, blood pressure, blood samples for safety labs, lung function and 24 hour monitoring of the heart. We will also take blood and urine samples to measure medication levels in the body.

GlaxoSmithKline will be funding the research and it will be recruiting at Synexus in 7 of their centres in the UK.

Detailed description:

Arms: arm 1: 7 day repeat dose
Interventions: intervention 1: GSK573719
Intervention descriptions: intervention 1: 7 day repeat dose

Protocol documents:
Clinical trial NCT00733421
Conditions: Postoperative Pain
Keywords: Day surgery Hallux Valgus Pain Analgesics
Sponsor: Karolinska Institutet
Start date: 2008-10-01; Completion date: 2009-08-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The effects of none-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase inhibitors (Coxibs) on the formation of bone and fracture healing have been a matter of debate since long.

There is, however, limited data in humans and further prospective randomised studies are warranted. Ekman et al studied in a prospective randomised double blind study the effects of celecoxib, a selective cox-II-inhibitor, on pain and bone healing following spine surgery. They found significant effects on reduction of pain and need for opioid analgesics postoperatively but could see no negative effects the numbers of "none-unions" at a 1-year follow up 3.

In a similar prospective randomised double-blind study design significant effects in reduction of pain and need for rescue analgesia was seen from the use of celecoxib in the perioperative multi-modal pain strategy for cruciate-ligament reconstruction and no negative effects could bee seen on six month follow-up of the strength of the reconstructed ligament.

The aim of the present study is to further study the effects of the perioperative use of etoricoxib, a selective cox-II-inhibitor (Coxibs), in a prospective randomised double-blind study on bone healing, pain and need for rescue analgesia in patients undergoing elective Hallux Valgus surgery with a standardised surgical technique including an osteotomy of metatarsale I and excision of exostosis.

Study population 100 American Society of Anesthesiology (ASA) physiological status1-2 patients scheduled for elective hallux valgus (HV) surgery

The patients are going to be randomised into 2 groups, 50 patients in each;

1. etoricoxib 90 mg once daily x 5
2. tramadol 100 mg twice daily x 5

First line rescue medication t. paracetamol 1 gr up to 4 gram daily Second line rescue t. oxycodone 10 mg

Primary study variables:

* X-ray evaluation (computer tomography (CT)-investigation) of bone healing assessed a CT-scan modelling of the osteotomy at twelve weeks after surgery
* Number of patients requiring rescue medication
* Patient assessment using "brief pain inventory" 24 hours and 2 weeks after surgery

Secondary study variables are;

* Visual Analogue Scale (VAS) grading Day 1-7
* Compliance to base medication
* Need for rescue analgesia Day 1-7
* Adverse Effects

  * Experience of any emetic symptoms
  * Experience of any gastrointestinal symptoms
* Satisfaction with pain medication Day 20
* Wound dressing Day 20
* Clinical evaluation 17 weeks, final assessment

Detailed description:
See brief summary

Arms: arm 1: Active study drug:

Etoricoxib 90 mg once daily arm 2: Tramadol 100 mg slow release twice daily
Interventions: intervention 1: etoricoxib intervention 2: tramadol
Intervention descriptions: intervention 1: 90 mg once daily intervention 2: 100 mg twice daily

Protocol documents:
Clinical trial NCT00735553
Conditions: Uterine Fibroids
Keywords: Uterine Fibroids
Sponsor: Repros Therapeutics Inc.
Start date: 2008-08-01; Completion date: 2009-08-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.

Detailed description:
Subjects with documented uterine fibroids, screening UFS-QOL severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. Following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. The study duration is approximately six months, comprised of a one-month screening period, 4 month treatment period and one month follow-up period. Subjects' blood will be drawn in a fasting state to obtain the pre-dose trough (PK) levels of study drug at each study drug dosing/dispensation visit to determine the potential for drug accumulation.

Arms: arm 1: 25 mg oral daily dose of Proellex arm 2: 50 mg oral daily dose of Proellex arm 3: oral daily dose of placebo
Interventions: intervention 1: Proellex intervention 2: Proellex intervention 3: Placebo
Intervention descriptions: intervention 1: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months intervention 2: Two 25 mg mg capsules of Proellex® orally daily for up to four months intervention 3: Two placebo capsules orally daily for up to four months

Protocol documents:
Clinical trial NCT00735709
Conditions: Major Depressive Disorder
Keywords: Depression Depressive Disorder Mood Disorder Mental Disorder Melancholia, Involutional Paraphrenia, Involutional Drug Therapy
Sponsor: Takeda
Start date: 2008-08-01; Completion date: 2009-08-01
Enrollment: 560 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effectiveness and safety of vortioxetine, once daily (QD), in patients with Major Depressive Disorder.

Detailed description:
The drug that was tested in this study is called vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying dosages of vortioxetine.

The study enrolled 560 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

* Vortioxetine 1 mg
* Vortioxetine 5 mg
* Vortioxetine 10 mg
* Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but had no active ingredient.

All participants were asked to take one capsule at the same time each day throughout the study.

This multi-centre trial was conducted in Europe, Asia, Australia, and South Africa. The overall time to participate in this study was up to 14 weeks. Participants made 7 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.

Arms: arm 1: Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks. arm 2: Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks. arm 3: Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks. arm 4: Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Interventions: intervention 1: Vortioxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Encapsulated immediate-release vortioxetine tablets intervention 2: Vortioxetine placebo-matching capsules

Protocol documents: