A Phase 3 interventional study of Megestrol acetate concentrated suspension 110 mg/mL and Placebo in Anorexia, Cachexia and Weight Loss, sponsored by Par Pharmaceutical, Inc.. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-23.
Sponsored by Par Pharmaceutical, Inc. · Phase 3, Interventional, and Treatment
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
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 5 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
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Exclusion Criteria:
Megestrol acetate concentrated suspension 110 mg/mL
Drug: Megestrol acetate concentrated suspension 110 mg/mL
Placebo suspension
Drug: Placebo
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
Also known as: Megace ES
Placebo oral suspension, 5 mL once daily
Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase
The Nutrition Data System for Research (NDSR) was used to determine nutrient and caloric value for foods and beverages consumed and recorded by subjects over a 3-day assessment period prior to each visit. Total number of calories consumed during each 3-day assessment was averaged over available values to determine the week's daily caloric intake value.
Time frame: 8 weeks
Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline
Time frame: Baseline, Week 4 and Week 8
Change in Weight Over the Course of the 8-week Double-blind Phase
Time frame: Baseline, Week 1, 2, 3, 4, 6, and 8
Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale
Subjects marked 6 items on a visual analog scale (VAS) appetite scale including feeling not hungry to hungry, not nauseated to nauseated, empty to full, not satiated to satiated; weak to strong desire to eat; and ability to eat none to a large amount of food
Time frame: Baseline, Weeks 1, 2, 3, 4, 6 and 8
| Milestone | DB MA-CS 550 mg/Day | DB Placebo | OL MA-CS 550 mg/Day |
|---|---|---|---|
| Started | 4 | 1 | 0 |
| Completed | 0 | 0 | 0 |
| Not completed | 4 | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 |
| Withdrew: Non-compliance | 2 | 0 | 0 |
| Withdrew: Study discontinued | 1 | 1 | 0 |
| Milestone | DB MA-CS 550 mg/Day | DB Placebo | OL MA-CS 550 mg/Day |
|---|---|---|---|
| Started | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 |
The Nutrition Data System for Research (NDSR) was used to determine nutrient and caloric value for foods and beverages consumed and recorded by subjects over a 3-day assessment period prior to each visit. Total number of calories consumed during each 3-day assessment was averaged over available values to determine the week's daily caloric intake value.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Subjects marked 6 items on a visual analog scale (VAS) appetite scale including feeling not hungry to hungry, not nauseated to nauseated, empty to full, not satiated to satiated; weak to strong desire to eat; and ability to eat none to a large amount of food
No measurements were reported for this outcome.
Collected over Approximately 98 days (from informed consent through 7 days following the last dose of study drug or up until the last protocol-specified study visit, whichever occurred later). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DB MA-CS 550 mg/Day | — | 2/4 (50%) | 3/4 (75%) |
| DB Placebo | — | 0/1 (0%) | 1/1 (100%) |
| OL MA-CS 550 mg/Day | — | — | — |
| Event | DB MA-CS 550 mg/Day | DB Placebo | OL MA-CS 550 mg/Day |
|---|---|---|---|
| Cardiac arrestCardiac disorders | 1/4 | 0/1 | — |
| OesophagitisGastrointestinal disorders | 1/4 | 0/1 | — |
| Disease progressionGeneral disorders | 1/4 | 0/1 | — |
| Pneumonia aspergillusInfections and infestations | 1/4 | 0/1 | — |
| Haemoglobin decreasedInvestigations | 1/4 | 0/1 | — |
| DehydrationMetabolism and nutrition disorders | 1/4 | 0/1 | — |
| ComaNervous system disorders | 1/4 | 0/1 | — |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/4 | 0/1 | — |
| HypotensionVascular disorders | 1/4 | 0/1 | — |
| Event | DB MA-CS 550 mg/Day | DB Placebo | OL MA-CS 550 mg/Day |
|---|---|---|---|
| Weight decreasedInvestigations | 0/4 | 1/1 | — |
| AnemiaBlood and lymphatic system disorders | 2/4 | 0/1 | — |
| VomitingGastrointestinal disorders | 1/4 | 0/1 | — |
| DehydrationMetabolism and nutrition disorders | 1/4 | 0/1 | — |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/4 | 0/1 | — |
| Renal failureRenal and urinary disorders | 1/4 | 0/1 | — |
All subjects who received at least 1 dose of study medication and who had at least 1 on-therapy safety assessment
| Age, Categorical(Participants) | DB MA-CS 550 mg/Day | DB Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 2 |
| >=65 years | 3 | 0 | 3 |
| Sex: Female, Male(Participants) | DB MA-CS 550 mg/Day | DB Placebo | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 2 | 0 | 2 |
| Ethnicity (NIH/OMB)(Participants) | DB MA-CS 550 mg/Day | DB Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 4 | 1 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | DB MA-CS 550 mg/Day | DB Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 2 | 0 | 2 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | DB MA-CS 550 mg/Day | DB Placebo | Total |
|---|---|---|---|
| United States | 4 | 1 | 5 |
This study is terminated, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Par Pharmaceutical, Inc.