Clinical Trials Register

We tested the oral form of testosterone, testosterone undecanoate (Andriol, NV Organon, The Netherlands), in men with PADAM and evaluated its efficacy and safety in Korean male patients. Testosterone replacement with long-acting Testopel pellets had a lower rate of infection (0.3%, 1/292 procedures) as compared with historical data from the Organon testosterone pellet (1.4-6.8%). Additionally, the rate of pellet extrusion was substantially lower (0.3%, 1/292 procedures) as compared with historical data (8.5-12%).

Dec 1994.A single dose study to compare the efficacy of acetaminophen sustained release pediatric chewable tablets to ibuprofen suspension in febrile children. Dec 1994. A phase III double-blind, single dose study of the comparative antipyretic effectiveness and safety of standard and double standard (C-47) doses of acetaminophen in febrile children. Jan 1984.A phase III double-blind, single dose study of the comparative antipyretic effectiveness and safety of standard and double standard (C-47) doses of acetaminophen in febrile children. Jan 1984.

A phase IV, multi-centre, double-blind, randomised, parallel group study in general practice to compare the efficacy and tolerability of inhaled salmeterol xinafoate 50 micrograms bd with placebo, both administered via the Diskhaler, in the treatment of episodic asthma induced by upper respiratory tract infection (URTI) in children. A phase III multiple dose use study of APAP extended release pediatric suspension compared to Children’s Tylenol® elixir in the treatment of febrile children. A phase III multiple dose use study of APAP extended release pediatric chewable tablets compared to Children’s Tylenol® chewable tablets in the treatment of febrile children. Controlled clinical study comparing the efficacy of twice daily applications of westcort (hydrocortisone valerate) cream 0,2% and Kenalog (triamcinolonacetonide) cream 0,1% in the treatment of children with atopic dermatitis.

(TENDRIL MRIâ„¢ CLINICAL INVESTIGATION)

A Phase IIIb/IV Randomized, Controlled, Double-blind, Double-dummy, Parallel Group Study to Compare the Efficacy of Fidaxomicin to Vancomycin in the Sustained Clinical Cure of Clostridium Difficile Infection in Adults Receiving Immunosuppressive Therapy. A perioperative, single-arm multicentre Phase II academic trial to investigate the efficacy and safety of Panitumumab in combination with Irinotecan/5-Fluorouracil/Leucovorin (FOLFIRI) in patients with previously untreated, wild-type KRAS, potentially resectable colorectal cancer liver metastases. A multicentre, randomised, double-blind, parallel group study comparing the efficacy and safety of inhaled salmeterol xinafoate 50mcg bd with that of salbutamol 200mcg to use “as required” from Diskhalers for twelve months in children with asthma. A 9-Week, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dosage (up to 425 mg/day), Parallel-Group Study to Evaluate the Efficacy and Safety of Modafinil (Film-Coated Tablet) in Children with Attention-Deficit/Hyperactivity Disorder. A double-blind, parallel group, study to compare the efficacy and safety of piracetam with placebo in children with specific learning disabilities.

The low infection and extrusion rates observed may have been the result of the manufacturing process, which results in small, smooth-surfaced pellets; the absence of foreign material within the pellet packaging; and/or differences in the surgical implantation technique used. Though Testopel pellets have been used in the United States for several decades, more research is needed to document their safety and efficacy. Long-acting subcutaneous testosterone pellets provide sustained and steady testosterone levels for 3 to 6 months. Testopel subcutaneous crystalline testosterone pellets are U.S.-approved for the treatment of men with testosterone deficiency syndrome. Published experience with testosterone pellets manufactured by Organon has noted relatively high rates of pellet extrusion and infection.

ALFApump system versus large volume paracentesis in the treatment of refractory ascites. A multicentre randomised controlled study. Determination of the pharmacokinetics and safety of risperidone at steady state in children and adolescents 5 to less than 18 years of age.

Piracetam for the treatment of sickle cell disease in children – a double blind test. The question of correlations between biological and clinical indices in children with mental deficiency. The clinical investigation of piracetam (UCB 6215, Nootropil) in treatment of mentally delayed children with hyperactivity. Statistical report of a controlled trial of the effect of Nootropil in epileptic children.

Inefficacy of piracetam in the prevention of painful crises in children and adolescents with sickle cell disease. Gallet JP, Dicetel capsules, report of the clinical expert evaluation (in children), report no 20, May 7, 1975. An Open-Label Pilot Study to Evaluate the Safety Of Pneumococcal 7-Valent Conjugate Vaccine [Diphtheria Crm197 Protein] (Prevenar) in Healthy Adults and Children at 3 to 5 Years Old. Final medical report Acceptance study with Mucosolvan 15 mg and 30 mg in children.

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