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Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension

NCT00637806 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2016-05-02

Study results available
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Summary

To compare the effect of megestrol acetate concentrated suspension and placebo on caloric intake in patients with cancer-associated anorexia.

Conditions

Interventions

DRUG

Megestrol acetate concentrated suspension 110 mg/mL

Megestrol acetate concentrated suspension 110 mg/mL given as an oral dose of 550 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase

DRUG

Megestrol acetate concentrated suspension 60 mg/mL

Megestrol acetate concentrated suspension 60 mg/mL given as an oral dose of 300 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase

DRUG

Placebo

Placebo oral suspension, 5 mL once daily

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Par Pharmaceutical, Inc.

    lead INDUSTRY

Principal Investigators

  • Lynn D Kramer, MD · Par Pharmaceutical, Inc.

  • Janet Bull, MD · Four Seasons Hospice and Paliative Care

  • Veena Charu, MD · Pacific Cancer Medical Center, Inc.

  • Bart Frizzell, MD · Wake Forest University, Dept of Radiation Oncology

  • Mehool Patel, MD · Summit Oncology Associates, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2006-09-30
Completion
2006-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00637806 on ClinicalTrials.gov