Treatment of Cancer-Associated Anorexia Using Megestrol Acetate Concentrated Suspension
This study has been terminated.
(Difficulty finding the required patient population)
Sponsor:
Par Pharmaceutical, Inc.
Collaborator:
PRA International
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT00637806
First received: March 11, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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:
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 |
|---|---|
|
Active Comparator: 1
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
Other Name: Megace ES
|
|
Active Comparator: 2
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
Other Name: Megace ES
|
| Placebo Comparator: 3 |
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: | VP Clinical & Medical Affairs, Par Pharmaceutical, Inc |
| ClinicalTrials.gov Identifier: | NCT00637806 History of Changes |
| Other Study ID Numbers: | 100.2.C.005 |
| Study First Received: | March 11, 2008 |
| Last Updated: | March 11, 2008 |
| 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:
|
Anorexia Cachexia Weight Loss Signs and Symptoms, Digestive Signs and Symptoms Emaciation Body Weight Changes Body Weight Megestrol Megestrol Acetate Antineoplastic Agents, Hormonal Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Appetite Stimulants Central Nervous System Stimulants Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013