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| Name | Class |
|---|---|
| Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | INDUSTRY |
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This study is designed to determine whether an oral perioperative medication (alvimopan--a selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alvimopan | Experimental | Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days. |
|
| Placebo | Placebo Comparator | Perioperative administration of placebo, at same dosing interval as study drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alvimopan | Drug | Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Length of Hospital Stay | Length of stay = date/time of hospital dismissal - date/time of end of surgery | Patients will be followed for the duration of their hospital stay, an expected average of 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Ileus Incidence | Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus. | Patients will be followed for 30 days postop |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie Bakkum-Gamez, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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The study took place at Mayo Clinic in Rochester, Minnesota from January 2013 to June 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alvimopan | Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days. |
| FG001 | Placebo | Perioperative administration of placebo, at same dosing interval as study drug. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics are provided for the subjects who completed study follow up.
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| ID | Title | Description |
|---|---|---|
| BG000 | Alvimopan | Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Length of Hospital Stay | Length of stay = date/time of hospital dismissal - date/time of end of surgery | Intent to Treat analysis | Posted | Mean | Standard Deviation | days | Patients will be followed for the duration of their hospital stay, an expected average of 5 days |
|
Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alvimopan | Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thromboembolic event | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jamie N. Bakkum-Gamez | Mayo Clinic | 507-266-8661 | Bakkum.Jamie@mayo.edu |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
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| ID | Term |
|---|---|
| C419502 | alvimopan |
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| Placebo | Drug | Perioperative administration of placebo, at same dosing interval as study drug. |
|
| Nasogastric tube placement in surgery |
|
| Post-op did not have laparotomy |
|
Perioperative administration of placebo, at same dosing interval as study drug.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Surgery Type | Number | participants |
|
| Cancer Stage | Cancer Stage used the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) staging system. For ovarian cancer, there are 4 stages: stage I: confined to the organ of origin, stage II: invasion of surrounding organs or tissue, stage III: spread to distant nodes or tissue within the pelvis, stage IV: distant metastasis(es) | Number | participants |
|
| Residual Disease | Number | participants |
|
|
|
|
| Secondary | Postoperative Ileus Incidence | Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus. | Intent to treat analysis | Posted | Number | participants | Patients will be followed for 30 days postop |
|
|
|
|
| 9 |
| 66 |
| 52 |
| 66 |
| EG001 | Placebo | Perioperative administration of oral placebo, at same dosing interval as study drug, starting with one dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.. | 10 | 68 | 57 | 68 |
| Ascites | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pelvic Fluid Collection | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Electrolyte Imbalance | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Malaise (Failure to thrive) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Wound Dehiscence | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Wound Infection | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Wound Complication | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mania | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematoma | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fluid Retention | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sepsis | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arrhythmias | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thromboembolic event | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pulmonary Edema | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Biliary Leak | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastroparesis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Small Bowel Obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Small Bowel Perforation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Weight Loss | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Increased international normalized ratio (INR) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Epistaxis | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lymphedema | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lymphangitis | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Electrolyte Imbalance | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Elevated Liver Enzymes | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Generalized Muscle Weakness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Delirium | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tinnitus | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neuropathy, sensory | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cystotomy | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pelvic Abscess | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary Incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary Tract Obstruction | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bladder Symptoms | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic reaction to chemo | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonthorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Wound Infection | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Wound Complication | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vaginal Infection | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blepharitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin Infection | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |