PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Clinical Trial, Phase III”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 19 recordsLinked to original sources
PubMed1991

[Clinical evaluation of 99mTc-hexakis 2-methoxy isobutyl isonitrile (MIBI): multicenter phase III clinical trial].

Multicenter Phase III clinical trial on a new myocardial imaging agent, 99mTc-hexakis 2-methoxy isobutyl isonitrile (99mTc-MIBI), was carried out in 464 patients with various cardiac disorders. Both planar and tomographic images provided high-quality regional myocardial perfusion images which correlated well with 201TlCl images. The positive ratios of myocardial infarction and angina pectoris by the agent were as high as that of 201TlCl. In addition, ventricular function and wall motion could be assessed with first-pass and ECG gated studies. There was no serious adverse reaction which were attributed to 99mTc-MIBI in any of patients studied. A transient metallic taste was observed immediately after the injection in approximately 64% of the patients. Based on its safety and efficacy, the clinical usefulness of 99mTc-MIBI was observed in 562 (93.1%) of 604 injections. In conclusion, 99mTc-MIBI was useful as a imaging agent of myocardial blood flow.

Adolescent↗
PubMed1992

[The assessment of clinical usefulness of 131I-MIBG scintigraphy for localization of tumors of sympathetic and adrenomedullary origin--a report of multicenter phase III clinical trials].

A phase III clinical study of 131I-metaiodobenzylguanidine (131I-MIBG) was performed in 66 patients with tumors of sympathetic and adrenomedullary origin, including 32 patients with suspected pheochromocytoma, 25 with suspected neuroblastoma, 7 pre- or postoperative medullary carcinoma of the thyroid and each with carcinoid and suspected Sipple's syndrome. A total of 150 sites which were confirmed for presence (72 sites) or absence (78 sites) of tumors were examined on 131I-MIBG scintigrams. True positive ratio of the scintigraphy was 84.7% (61/72) and true negative ratio was 94.9% (74/78). Positive scintigraphy was obtained in 86.5% (32/37) of pheochromocytoma, 78.6% (22/28) of neuroblastoma and 100% (6/6) of medullary carcinoma of the thyroid. Accumulation of 131I-MIBG was seen in 16.8% of normal adrenal glands. Neither adverse reactions nor abnormal laboratory findings were noted in relation to 131I-MIBG injections. Our study indicates that 131I-MIBG is a safe and clinically useful radiotracers for the visualization and localization of tumors of sympathetic and adrenomedullary origin.

3-Iodobenzylguanidine↗
PubMed1988

A design for phase II testing of anticancer agents within a phase III clinical trial.

A design for testing new anticancer agents is proposed such that the initial testing of new agents (phase II trials) is included within the framework of a comparative clinical trial (phase III). Randomization between phase II trials and the treatment groups of the phase III trial enforces consistency of patient selection and evaluation of response criteria. Patients who progress on the phase II trials of the new agents are randomized to one of the treatments of the phase III trial. Design issues, such as sample size and power, and analysis of the proposed design, are discussed. Advantages and disadvantages of the design are illustrated by sample size calculations for a current clinical trial in advanced breast cancer.

Antineoplastic Agents↗
PubMed1992

[Diagnostic value of a new myocardial perfusion agent, 99mTc-teboroxime (SQ30,217) in patients with coronary artery disease, utilizing a SPECT imaging protocol: a multicenter phase III clinical trial].

Technetium-99m teboroxime (TEBO) is a new technetium-based myocardial perfusion imaging agent, which has high myocardial extraction and rapid myocardial washout. Its rapid myocardial washout may necessitate rapid imaging protocols. This study was designed to perform exercise/rest SPECT imaging protocols with rapid data acquisition (from 2.8 +/- 1.4 min to 11.2 +/- 4.1 min after injection) in 171 patients with coronary artery disease, 15 patients with cardiomyopathy and 8 patients with other heart disease. The rapid imaging protocols resulted in a high prevalence of good image quality. The diagnostic value of TEBO was recognized from the high concordance of image findings with thallium-201 (201Tl) scintigraphy, 88.2% in the exercise protocol and 89.9% in the rest protocol. Also, the sensitivity and specificity of TEBO for detecting coronary artery disease were comparable (86.6% and 53.9%, respectively) with those of 201Tl (90.7% and 46.2%, respectively). No toxic effects of TEBO were observed in subjective and objective clinical findings and blood examinations. TEBO was finally evaluated to be useful in 98.4% of the patients. Thus, this agent has good clinical potential for myocardial perfusion imaging.

Aged↗
PubMed1992

Gd-DTPA as an intestinal contrast agent for MR imaging of the lower abdomen: phase III clinical trial.

Thirty-one patients were investigated with magnetic resonance (MR) imaging of the lower abdomen before and after the administration of gadopentetate dimeglumine (Gd-DTPA) solution per os or per rectum or from both routes for the opacification of the intestinal tract. The parameters evaluated were: (a) contrast medium distribution, (b) degree of filling of the bowel lumen, (c) contrast between the bowel lumen and the surrounding normal or pathological structures, and (d) whether the administration of the contrast agent improved the diagnostic ability of MR compared to computed tomography (CT) or plain MR of the same region. Gd-DTPA, at a concentration of 1 mmol/L, produced a positive signal irrespective of its dilution in the bowel and good contrast between the bowel lumen and the adjacent tissues or any possible pathological lesions. From the diagnostic point of view, after the administration of contrast medium, MR is comparable to CT and much superior to plain MR. It is concluded that opacification of the bowel with Gd-DTPA solution will improve the diagnostic yield of MR imaging of the lower abdomen.

Abdomen↗
PubMed1992

[Methodology of phase III clinical trials of hypocholesteremic agents. Do any reliable substitution criteria exist?].

Pathological events such as myocardial infarction or cardiac death due to hypercholesterolaemia are easily quantified and reliable parameters for assessing the value of lowering the serum cholesterol. However, these events are relatively rare during Phase III clinical trials, the duration of which does not exceed 1 year. To solve this problem, intermediary or substitute criteria have to be used which are predictive of cardiovascular complications related to this pathology. Substitute criteria such as total cholesterol LDL-cholesterol and HDL-cholesterol have been validated by epidemiological and/or clinical studies which have established their predictive value. These primary and secondary prevention trials and regression studies have been analysed. The possibility of more sensitive predictive values of certain lipid fractions and particles is discussed.

Adult↗
PubMed1989

The analysis of titration studies in phase III clinical trials.

Clinical trials commonly employ the titration design for certain drugs such as antihypertensives. In a Phase III trial the design has purposes distinct from those of a Phase I or II trial, as well as from those of a trial with a parallel design. In this paper we compare the titration design with the usual parallel design in their respective purposes for Phase III trials, explore the relevant questions addressed, and examine typical data from such trials. We also discuss work which focuses primarily on the Phase I or II titration trials. We formulate the problem in the framework of one-way contingency table augmented with incomplete data and obtain the maximum likelihood estimates of the parameters and their estimated variances/covariances via the EM algorithm. An example of a Phase III study of an antihypertensive agent illustrates the proposed procedure.

Analysis of Variance↗
PubMed1991

Phase III clinical trial with a new oral contraceptive containing 150 micrograms desogestrel and 20 micrograms ethinylestradiol.

Results are presented of a Phase III international multicentre trial to study the effect of a new low-dose oral contraceptive (OC) containing 20 micrograms ethinylestradiol and 150 micrograms desogestrel (Mercilon) regarding efficacy, cycle control, blood pressure, and acceptability. Altogether 1,684 women from 12 European countries were included in the study. Four pregnancies occurred, 3 of them patient failures, one tablet failure. The overall Pearl Index was 0.20. The frequency of irregular bleeding was comparable to that recorded with other commonly used low-dose OCs. No serious side effects occurred. The incidence of the most frequently reported subjective side effects--headache, nausea and breast tension--was already low after the first cycle of treatment and decreased to below pretreatment levels with continued use. There was a small increase in mean body weight, which was confined essentially to young women. The preparation did not affect the mean systolic or diastolic blood pressure. This new preparation has thus proved to be an effective, safe and well-accepted ultra low-dose oral contraceptive.

Adult↗
PubMedDate not supplied

Sample sizes for phase II and phase III clinical trials: an integrated approach.

In this paper the following problem of clinical research is explored. Several potential new treatments are available for use against a certain disease. These are evaluated in a series of pilot studies which will constitute phase II clinical trials. The most promising will then be compared with a standard treatment in a phase III trial. Of interest will be the number of patients needed for the complete research programme, the proportions of these that should be involved in each phase, and the number of treatments which should be tried. Optimal strategies are found which maximize the probability that the overall programme identifies a treatment which is significantly better than the standard.

Clinical Trials as Topic↗
PubMed1991

A multicentred, two-year, phase III clinical trial of norethisterone enanthate 50 mg plus estradiol valerate 5 mg as a monthly injectable contraceptive.

Norethisterone enanthate (NET-EN) 50 mg combined with estradiol valerate (EV) 5 mg was studied as a once-a-month injectable contraceptive with regard to effectiveness, cycle control, adverse events and acceptability. In eight Family Planning Centres from 5 Latin American countries, 652 fertile women were followed-up for a period of 24 months, providing a total of 10,689 woman-months of experience. Only 1 pregnancy occurred, in the first treated month a few days before the second injection (failure rate 0.11 per 100 woman-years). Under treatment, the first cycle was drastically shortened in most cases, but thereafter cycles tended to recover to pre-treatment patterns. There was a significant decrease of hypermenorrhea and dysmenorrheic cycles. Intracyclic bleeding and spotting appeared in 1.2% and 2.4%, respectively, and amenorrhea in 2.5% of cycles. Incidence of other adverse events was very low with the exception of weight gain of 2 Kg (28%). Continuation rate at 12 months was 64.7%. The cumulative discontinuation rate due to bleeding problems was 7.4% and 10.7% due to adverse events at 24 months.

Adolescent↗
PubMed1985

Bleomycin and radiation therapy in squamous cell carcinoma of the upper aero-digestive tract: a phase III clinical trial.

A group of 222 consecutive patients admitted with squamous cell carcinoma of the upper aero-digestive tract were studied in a prospectively randomized and stratified clinical trial. One-half of the patients received bleomycin injected intramuscularly 1 hour before the radiation treatment daily for 5 days a week; the other half received radiation therapy without the added chemotherapy. The total dose of radiation in both groups was about the same, and was given with curative intent even to the patients with advanced tumors who constituted the majority in both groups. Interstitial radiation as boost therapy or surgery was added in patients with residual tumor if the lesions were considered operable and the patient's condition would allow surgery. The addition of bleomycin did not increase the combined local and regional tumor control rates nor did it improve the survival, but did significantly increase the morbidity and the complication rate.

Adult↗
PubMed1987

A phase-III clinical trial of mefloquine in children with chloroquine-resistant falciparum malaria in Thailand.

Mefloquine is a highly effective drug for the treatment of falciparum malaria among adults, but studies of its effects on children are lacking. An open, noncomparative trial of mefloquine was therefore carried out among 84 children aged 5-12 years who were patients at the Hospital for Tropical Diseases, Mahidol University, Bangkok, Thailand. The drug was administered as a single dose of 18-29 mg base per kg body weight. Eighty-two of the 84 children completed a 42-day period of post-treatment observation. The drug was well tolerated also by 11 children with glucose-6-phosphate dehydrogenase deficiency, and all the children in the study cleared their parasitaemia initially (average clearance time, 65 hours). Furthermore, the clinical-chemical parameters measured exhibited no drug-related changes during the study. The radical cure rate of nearly 98% and high tolerance indicate that mefloquine can be used effectively and safely for the treatment of children aged 5-12 years who are suffering from uncomplicated falciparum malaria.

Child↗
PubMed1985

An open, randomized, phase III clinical trial of mefloquine and of quinine plus sulfadoxine-pyrimethamine in the treatment of symptomatic falciparum malaria in Brazil.

The clinical and parasitological response of adult male patients to mefloquine and to a combination of quinine and sulfadoxine-pyrimethamine during the treatment of falciparum malaria was compared. These patients were from an area in Brazil where Plasmodium falciparum is showing increasing resistance to quinine and to sulfadoxine-pyrimethamine. The drugs were administered to 100 patients (50 in each group), based on a randomized study design.The rates of clearance of parasitaemia and fever were similar in both groups. However, the parasitological cure rate ("S" response) was 100% for mefloquine but only 92% for quinine plus sulfadoxine-pyrimethamine. Tolerance was good in both groups. The main side-effects (nausea, vomiting, abdominal pain, and dizziness) were mild, transient and required no specific treatment. Nausea and vomiting were more frequent in patients who received quinine plus sulfadoxine-pyrimethamine, while abdominal pain and loose stools or mild diarrhoea were more frequent in the mefloquine group. Tinnitus and hearing difficulty were observed following the administration of quinine plus sulfadoxine-pyrimethamine, but not after mefloquine treatment. Laboratory tests of various haematological and biochemical parameters were not adversely affected in either group after drug administration.It can be concluded that mefloquine, given in a single oral dose of 1000 mg, is highly effective, well tolerated, and safe for the treatment of falciparum malaria in adult males in Brazil.

Adolescent↗