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| Sponsored by: |
M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00488072 |
Purpose
Primary Objective:
1. To determine if Mirtazapine in comparison to placebo will improve appetite in advanced cancer patients with anorexia and weight loss. An improvement of appetite is defined as a decrease of 2 in the appetite score from baseline on the Edmonton Symptom Assessment Scale (ESAS) at day 15 (+/-3 days).
Secondary Objectives:
| Condition | Intervention |
|---|---|
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Advanced Cancer Anorexia Weight Loss Insomnia |
Drug: Mirtazapine Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Preliminary Study to Explore the Effects of Mirtazapine on Appetite in Advanced Cancer Patients |
| Estimated Enrollment: | 98 |
| Study Start Date: | January 2007 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
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1: Experimental
Mirtazapine
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Drug: Mirtazapine
Randomization Portion = 15 mg PO daily x 15 days; Open Label Portion = 15 mg PO daily beginning day 15 and continuing until day 22. On day 22, Mirtazapine will be increased to 30 mg PO daily and this dose will continue until day 29.
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2: Placebo Comparator
Placebo
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Drug: Placebo
Randomization Portion = One tablet PO daily x 15 days; Open Label Portion = 15 mg PO daily Mirtazapine beginning day 15 and continuing until day 22. On day 22, Mirtazapine will be increased to 30 mg PO daily and this dose will continue until day 29.
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Shalini Dalal, MD | 713-792-6085 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Shalini Dalal, MD | |
| Principal Investigator: | Shalini Dalal, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Shalini Dalal, MD/Assistant Professor ) |
| Study ID Numbers: | 2005-0916 |
| Study First Received: | June 18, 2007 |
| Last Updated: | December 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00488072 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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Advanced Cancer Anorexia Weight Loss Insomnia |
Appetite Mirtazapine Placebo |
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Neurotransmitter Agents Adrenergic Agents Signs and Symptoms, Digestive Psychotropic Drugs Adrenergic alpha-Antagonists Mirtazapine Antidepressive Agents, Tricyclic Histamine Body Weight |
Signs and Symptoms Histamine Antagonists Weight Loss Anorexia Body Weight Changes Histamine H1 Antagonists Histamine phosphate Adrenergic Antagonists Antidepressive Agents |
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Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Signs and Symptoms, Digestive Physiological Effects of Drugs Psychotropic Drugs Histamine Agents Adrenergic alpha-Antagonists Mirtazapine Pharmacologic Actions Antidepressive Agents, Tricyclic Body Weight |
Signs and Symptoms Neoplasms Histamine Antagonists Therapeutic Uses Weight Loss Anorexia Body Weight Changes Histamine H1 Antagonists Adrenergic Antagonists Central Nervous System Agents Antidepressive Agents |