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Berita Ubat-ubatan
August 2000

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Regulatory Control Beyond 2000
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Separate Manufacturing Facilities For Cephalosporins
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Warning Label for products - NSAID
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Registration of Products Containing Insect Repellants
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Warning for Products containing Hydroquinone
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Actions To Be Taken Against Products Containing CISAPRIDE (PREPULSID)line.gif (87 bytes)
Licensing Update - June 2000
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The Changing Pharmaceutical and Traditional Medicine Premises Landscape: 1987 - 2000
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Additional Indications Approved for Registered Products
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GMP News
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Quality Control Training Course
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Sources of products registered with DCA As At 30.6.2000
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New Products Approved for Marketing in Malaysia
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NPCB officers to contact
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Clinical Trials

line_vertical.gif (147 bytes) line1.jpg (4914 bytes) CLINICAL TRIALS
(February – May 2000)

 

No.

Topic

Place of Trial

CTIL Holder

1. A randomised, double-blind, comparison of three doses of Entercavir vs. Lamivudine in Immunocompetent subjects with chronic Hepatitis B infection with viremia on Lamivudine therapy. (Phase III). Department of Medicine Hospital University
59100 Kuala Lumpur.
Bristol Myers Squibb (M) Sdn. Bhd.
2. A double-blind placebo-controlled trial to evaluate the efficacy and safety of Prucalopride tabletws in subjects with chronic constipation. (Phase III study). University of Malaya Kuala Lumpur. Johnson & Johnson Sdn. Bhd., Selangor.
3. An open, randomised, multicentre, phase II study to evaluate the safety and therapeutic efficacy of Smithkline Beecham Biologicals Immunotherapeutics candidate Hepatitis B pharmaccine, administered together with lamivudine, versus lamivudine alone, in adult patients with HBeAg positive chronic Hepatitis B.
  • Department of Medicine Hospital Kuala Lumpur.
  • Hospital Selayang
    Lebuhraya Selayang
    Kepong, Selangor.
Smithkline Beecham
Sdn. Bhd., Selangor.
4. A randomized, experiential double – blind active control study to explore the effect of a titrated regimen of omapatrilat in Hypertensive Asian subjects. (Phase III).
  1. Department of Medicine Hospital University
    59100 Kuala Lumpur.
  2. Hospital University Sains Malaysia
    16150 Kubang Kerian
    Kelantan
Bristol Myers Squibb

(M) Sdn. Bhd., Selangor.

5. Omapatrilat Versus Enalapril Randomized Trial of Utility in Reducing Events (Phase III). Department of Medicine Hospital Universiti
Kuala Lumpur
Bristol Myers Squibb (M) Sdn. Bhd., Selangor.
6. A phase I study of Raltitrexed (TomudexTM) during the boost phase of Radiotherapy in subjects with locally advanced squamous cell carcinoma (SCC) of the Head and Neck. Clinical Oncology Unit University of Malaya Medical Centre. Zeneca Pharma (M) Kuala Lumpur.
7. Phase II Multi-Centre Study of Caelyx and Cisplatin as primary treatment of patients with advanced Epitherial Ovarian Cancer. Hospital Pulau Pinang
Pulau Pinang.

University Hospital
Kuala Lumpur.

Schering – Plough Sdn. Bhd.
8. Intraconazole intravenous injectable solution : an expanded access protocol for the treatment of subjects with a proven systemic fungal infection. (Phase III) Medical Department
Hospital Kuala Lumpur.
Johnson & Johnson Sdn. Bhd.,
Petaling Jaya.
9. Randomized, Triple-blind, Two arm parallel study of the efficacy, tolerability and safety of losartan 50 mg titrated to Losartan 50 mg/Hydrochlorothiazide 12.5 mg, tritrated to Losartan 100 mg /Hydrochlorothiazide 25 mg Versus Amlodipine 5 mg titrated to Amlodipine 10 mg, titrated to Amlodipine 10 mg plus Hydrochlorothiazide 25 mg in patients with Isolated Systolic Hypertension. (Phase IV)
  1. Jabatan Nefrologi

    University Hospital

    Kuala Lumpur.

  2. Jabatan Nefrologi

Hospital Kuala Lumpur.

Merck, Sharp & Dohme (I.A.) Corp.,
Petaling Jaya.
10. The early association of Vapreotide to endoscopic ligation for the control of acute cirrhotic variceal bleeding and prevention of early rebleeding. (Phase III) Department of Surgery Faculty of Medicine Hospital University University Malaya. Dr. Chew Yoon Heng
Hospital University
University Malaya
Kuala Lumpur.