Pilot trials

TK NK2r antagonists showed interesting activities in preclinical models of depression, anxiety, asthma, gastrointestinal dysmotility and hypersensitivity, and urinary incontinence [1,3]. In clinical, NK2r antagonists antagonize NKA-induced bronchoconstriction and NKA-induced intestinal dysmotility. However, a pilot trial in asthma failed to show any clinical benefit by... 

Evins AE, Mays VK, Rigotti NA, et al A pilot trial of bupropion added to cognitive behavioral therapy for smoking cessation in schizophrenia. Nicotine Tob Res 3 397-M03, 2001... 

The Penumbra stroke system (Penumbra Inc., San Leandro, CA) includes two different revascularization options (1) thrombus debulking and aspiration may be achieved by a reperfusion catheter that aspirates the clot while a separator device fragments it, and (2) direct thrombus extraction may be performed by a ring retriever while a balloon guide catheter is used to temporarily arrest flow. This system has been tested in a pilot trial in Europe. Twenty patients (mean NIHSS 21) with a total of 21 vessel occlusions (7 ICA, 5 MCA, and 9 Basilar) were treated up to 8 hours after symptom onset. Recanalization prior to lA lysis was achieved in all cases (48% TIMI 2 52% TIMI 3). Seven patients were also treated with lA UK or rt-PA. Good outcome at 30 days (defined as mRS < 2 or NIHSS 4-point improvement) was demonstrated in 42%. The mortality rate was 45%, but there were no device-related deaths. There was one asymptomatic SAH and three symptomatic ICHs. A prospective, single-arm, multicenter trial is being conducted in the United States and Europe currently. 

Ginsberg MD, Hill MD, Palesch YY, Ryckborst KJ, Tamariz D. The alias pilot trial a dose-escalation and safety study of albumin therapy for acute ischemic stroke—I physiological responses and safety results. Stroke 2006 37 2100-2106. 

Muir KW, Lees KR. A randomized, double-blind, placebo-controUed pilot trial of intravenous magnesium sulfate in acute stroke. Stroke 1995 26 1183-1188. 

Saver XL, Kidwell C, Eckstein M, Starkman S. Prehospital neuroprotective therapy for acute stroke results of the field administration of stroke therapy-magnesium (fast-mag) pilot trial. Stroke 2004 35 el06-el08. 

Phase II investigates the compound s efficacy and safety in controlled clinical trials for a specific therapeutic indication. To eliminate as many competing factors as possible, Phase II trials are narrowly controlled. They are characterized as small—several hundred subjects with the indicated disease or symptoms—and are closely monitored. The control may be either a placebo study arm or an active control arm. The endpoint measured may be the clinical outcome of interest or a surrogate. Phase II trials may last for several months or even several years. Early pilot trials to evaluate safety and efficacy are called Phase Ila. Later trials, called Phase lib, are important tests of the compound s efficacy. These trials may constitute the pivotal trials used to establish the drug s safety and efficacy. At least one pivotal trial (most frequently a large, randomized Phase III study) is done. Only about one third of compounds entered into Phase II will begin Phase III studies [61],... 

The pilot trial was segmented into three different test runs. Test 1 full-flow pressurization without chemical treatment. Test 2 full-flow pressurization with chemical treatment. Test 3 recycle flow pressurization with chemical treatment. Testing was limited to 4 days (a total of 22 operational hours). Table 27.3 summarizes the experimental conditions of the three test series. 

We would certainly not expect them to improve. Even the researchers who conducted the study did not expect to find much of an effect. It was to just be a very small pilot trial to learn if patients would actually go along with us and to see if any subjects actually benefited, Lee Park recalls. 

Shoptaw S., Watson D.W., Reiber C. et al. Randomized controlled pilot trial of cabergoline, hydergine and levodopa/carbidopa Los Angeles Cocaine Rapid Efficacy Screening Trial (CREST). Addiction. 100(Suppl. 1) 78, 2005. 

Kampman K.M., Pettinati H., Lynch K.G. et al. A pilot trial of topiramate for the treatment of cocaine dependence. Drug Alcohol Depend. 75 233, 2004. 

The process is nearing the end of a 3000 hour pilot trial at the Shawinigan laboratory of Hydro-Quebec in a commercial scale Electro Prod Cell, or an ICI FM21 SP cell, divided by a membrane. The pilot plant based on commercially available electrochemical cells has a design capacity of 100 t/year [132], Compounds examined on the laboratory scale using the Ce(IV) methane sulfonic acid process are summarized in Table 11. 

There is no succinct and universally accepted definition of a pilot trial. It is usually open in design and small in scale. Its use sometimes implies some degree of uncertainty either about... 

Friess GG, B alkadi M, Harvey WH. Simultaneous cisplatin and etoposide with radiation therapy in loco-regional non-small cell lung cancer. Final results of a pilot trial. IN Small Cell Lung Cancer and Nonsmall Cell Lung Cancer. Gralla R J, Einhom LH (eds). Royal Society of Medicine Services Limited, 1989,... 

Davidson JR, Potts N, Richichi E, Krishnan R, Ford SM, Smith R, Wilson WH (1993b) Treatment of social phobia with clonazepam and placebo. J Clin Psychopharmacol 13 423-428 Davidson JR, Weisler RH, Butterfield Ml, Casat CD, Connor KM, Barnett S, van Meter S (2003) Mirtazapine vs. placebo in posttraumatic stress disorder a pilot trial. Biol Psychiatry 53 188-191... 

In a further trial involving a high O2 dosage rate (76 mg/L/month in a pilot trial with 141-L tanks), binding of acetaldehyde with anthocyanins and flavanols was suggested as a reason for low concentrations of... 

Riemann DS, Velthaus S, Laubenthal S, et al REM-suppressing effects of amitriptyline and amitriptyhne-N-oxide after acute medication in healthy volunteers results of two uncontrolled pilot trials. Pharmacopsychiatry 23 253-258, 1990... 

McElroy SL, Soutullo CA, Keck PE Jr, et al. A pilot trial of adjunctive gabapentin in the treatment of bipolar disorder. Ann Clin Psychiatry 1997 9 99-103. 

Standard methods of analysis published by bodies such as the American Society for Testing and Materials (ASTM), de Normalisation (CEN), or ISO are rigorously tested and validated in method performance, or validation, studies. These interlaboratory trials can establish reproducibility and method bias and also give some confidence that the method can be used in different environments. Laboratories are chosen with an expectation that they can competently follow the proposed method, which will have already been extensively validated before an interlaboratory trial is contemplated. To this end, a pilot trial is sometimes undertaken to ensure the method description can be followed and to give an initial estimate of the precision of the method. 

Brara PS, Moussavian M, Grise MA, Peilly JP, Fernandez M, Schatz RA, Teirstein PS. Pilot trial of oral rapamycin for recalcitrant restenosis. Circulation 2003 107 1722-4. 

In a pilot trial with 12 patients with hepatic metastases from colorectal cancer, the concentrations of the curcumin in normal and malignant human liver tissue after patients received 450-3600 mg of curcumin daily for 1 week prior to surgery were not sufficient to elicit pharmacological activity, perhaps because of the extensive degree to which curcumin was metabolized in the intestine. 

As with other packaging components, the incoming tests and specifications of metered valves, inspection attributes, and AQLs (acceptable quality levels) will need to be coordinated with the supplier. The valve should be considered as a critical package component and have incoming performance tests, such as spray weights and weight loss [13,14], The performance test could be conducted on a sample of the valve lots from either scale-up or pilot trials before the validation lots are prepared. This information may also be available for each lot from the supplier. It is recommended that each test shown in Table 3 be conducted on at least three valve lots as part of the validation program. 

The outcomes of this pilot trial led to the design and execution of a larger prospective intervention that evaluated multibotanical formulas based upon rose hips... 

Further to the above pilot trial, the Bivalirudin Angioplasty Trial (BAT) was designed, In this trial, 4098 patients undergoing... 

Cannon CR McCabe CH, Henry TD, et al. A pilot trial of recombinant desulfatohirudin compared with heparin in conjunction with tissue-type plasminogen activator and aspirin for acute myocardial infarction results of the thrombolysis in myocardial infarction (TIMI) 5 trial, J Am Coll Cardiol 1994 23 993-1003. 

We can obtain several lessons from these pilot trials (30-34,47). First, the angiographic in-stent binary restenosis was lower than I0%. The ORBIT trial had 7% of in-stent binary restenosis and 0.60 mm of late loss. 

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