Treatment of Cancer-Associated Anorexia Using Megestrol Acetate Concentrated Suspension - Full Text View

Sponsor:	Par Pharmaceutical, Inc.
Collaborator:	PRA International
Information provided by:	Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:	NCT00637806

Purpose

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

Condition	Intervention	Phase
Anorexia Cachexia Weight Loss	Drug: Megestrol acetate concentrated suspension 110 mg/mL Drug: Megestrol acetate concentrated suspension 60 mg/mL Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study of Megestrol Acetate Concentrated Suspension for the Treatment of Cancer-Associated Anorexia in Subjects With Cancer of Multiple Types

Resource links provided by NLM:

MedlinePlus related topics: Cancer Weight Control

Drug Information available for: Megestrol acetate Megestrol

U.S. FDA Resources

Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:

Caloric intake [ Time Frame: Daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Weight [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Patient reported appetite [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Body composition [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Enrollment:	4
Study Start Date:	June 2006
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Megestrol acetate concentrated suspension 110 mg/mL	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
2: Active Comparator Megestrol acetate concentrated suspension 60 mg/mL	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
3: Placebo Comparator	Drug: Placebo Placebo oral suspension, 5 mL once daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Cancer of multiple types in stage II, III, or IV and not a candidate for chemotherapy; but may have been receiving radiation therapy
Fair, poor, or very poor appetite
Cancer-associated anorexia/cachexia (documented weight loss of 2% over the prior week, or at least 5% within past 30 days, or at least 7.5% over prior 3 months, or at least 10% over prior 6 months)
Weight loss perceived to be associated with diminished appetite
Eastern Cooperative Oncology Group Performance score of 0, 1, or 2
Life expectancy greater than 3 months
Alert and mentally competent to complete study assessments
Women of child-bearing potential required to use an adequate and reliable method of contraception. Post-menopausal women have to have been so for at least 1 year
Screening laboratory values must not be clinically significant (some exceptions per protocol)

Exclusion Criteria:

Brain, or head and neck tumors that may interfere with food consumption
AIDS-related wasting
Radiation therapy to head and neck, abdomen, or pelvis within past 6 weeks, or for whom radiation therapy is anticipated during the study such that the result may interfere with food consumption
Presence of conditions that interfere with oral intake or ability to swallow
Absence of normally functioning gut
Known mechanical obstruction of the alimentary or biliary tract, or malabsorption syndrome
Intractable or frequent vomiting
Clinically significant diarrhea
History of thromboembolic events, or on long-term anticoagulation for thromboembolism
Uncontrolled diabetes mellitus, or symptomatic hypoadrenalism
Poorly controlled hypertension or congestive heart failure
Pregnant/lactating females, or planning on becoming pregnant
Use of appetite stimulants within past 30 days
Use of parenteral nutrition or tube feedings within past 1 week
Chronic use of steroids within past 3 months (intermittent short-term use allowed)
Current use of illicit substances
Allergy, hypersensitivity, or other contraindication to megestrol acetate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637806

Locations

United States, California
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
United States, North Carolina
Four Seasons Hospice and Paliative Care
Flat Rock, North Carolina, United States, 28731
Wake Forest University
High Point, North Carolina, United States, 27262
United States, Ohio
Summit Oncology Associates, Inc.
Akron, Ohio, United States, 44304

Sponsors and Collaborators

Par Pharmaceutical, Inc.

PRA International

Investigators

Study Chair:	Lynn D Kramer, MD	Par Pharmaceutical, Inc.
Principal Investigator:	Janet Bull, MD	Four Seasons Hospice and Paliative Care
Principal Investigator:	Veena Charu, MD	Pacific Cancer Medical Center, Inc.
Principal Investigator:	Bart Frizzell, MD	Wake Forest University, Dept of Radiation Oncology
Principal Investigator:	Mehool Patel, MD	Summit Oncology Associates, Inc.

More Information

No publications provided

Responsible Party:	Par Pharmaceutical, Inc ( VP Clinical & Medical Affairs )
Study ID Numbers:	100.2.C.005
Study First Received:	March 11, 2008
Last Updated:	March 11, 2008
ClinicalTrials.gov Identifier:	NCT00637806 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Par Pharmaceutical, Inc.:

Megestrol acetate
Anorexia
Cachexia
Cancer

Unintended weight loss
Body weight
Appetite
Megace ES

Additional relevant MeSH terms:

Signs and Symptoms, Digestive
Antineoplastic Agents, Hormonal
Contraceptive Agents
Antineoplastic Agents
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Cachexia
Central Nervous System Stimulants
Reproductive Control Agents
Emaciation
Megestrol

Pharmacologic Actions
Body Weight
Signs and Symptoms
Therapeutic Uses
Weight Loss
Anorexia
Body Weight Changes
Contraceptives, Oral, Synthetic
Central Nervous System Agents
Appetite Stimulants
Megestrol Acetate

ClinicalTrials.gov processed this record on November 09, 2009