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NCT00488072 · ClinicalTrials.gov registry record · Phase 2
Effects of Mirtazapine on Appetite in Advanced Cancer Patients
A Phase 2 study of Insomnia and Advanced Cancer, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
- 1
- Study location
NCT00488072 is a Phase 2 study of Insomnia and Advanced Cancer that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 98 participants, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00488072, a Phase 2 study of Insomnia and Advanced Cancer, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary objective: This is a preliminary study 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 objective-A: To determine if Mirtazapine in comparison to placebo will improve insomnia ( as measured by Pittsburgh Sleep Quality Index) on day 15 ( +/- 3 days), and day 29 ( +/- 3 days) Secondary objective - B: To determine if Mirtazapine in comparison to placebo will improve other common symptoms such as pain, nausea and fatigue( as measured by ESAS), depression and anxiety ( as measured by Hospital Anxiety and Depression scale), and quality of life ( as measured by Functional Assessment of Anorexia/Cachexia Therapy ) in advanced cancer patients with anorexia/cachexia, on days 15 (+/-3 days), and 29 (+/-3 days) Other Objectives: To provide exploratory data on the effects of Mirtazapine on weight gain, and preservation/gain lean muscle mass ( anthropometric measurements and Bioelectric Impedance), on days 15 (+/-3 days), and 29 (+/-3 days). To provide exploratory data on the effects of a Mirtazapine dose increase to 30 mg on decreased side effects of drug and increased appetite on day 29 (+/-3 days).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Mirtazapine
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2007-01-08 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00488072
The ClinicalTrials.gov registry entry for NCT00488072 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (42% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Insomnia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00488072 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00488072 about?
NCT00488072 is a clinical study titled "Effects of Mirtazapine on Appetite in Advanced Cancer Patients". Primary objective: This is a preliminary study 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 As...
What is the current status of trial NCT00488072?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2007-01-08. Estimated completion is 2027-12-31.
What conditions does trial NCT00488072 study?
This clinical trial studies the following conditions: Insomnia, Advanced Cancer, Weight Loss, Anorexia.
What interventions are being tested in trial NCT00488072?
The interventions under investigation include: Placebo (DRUG), Mirtazapine (DRUG).
Who is sponsoring clinical trial NCT00488072?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00488072 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.