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Treatment of Cancer-anorexia Using Megestrol Acetate Concentrated Suspension in Lung or Pancreatic Cancer Patients

NCT00637728 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2016-06-23

Study results available
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Summary

Purpose of the study is to compare the effects of megestrol acetate concentrated suspension and placebo on caloric intake for the treatment of cancer-associated anorexia in patients with lung or pancreatic cancer

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

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.

  • John N Mehanna, MD · Western Maryland Health System

  • M.Daud Nawabi, MD · Lowcountry Hematology & Oncology, PA

  • Marc A Saltzman, MD · Innovative Medical Research of South Florida, 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 NCT00637728 on ClinicalTrials.gov