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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_074 |
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A new intravenous medication is being tested for the prevention of the nausea and vomiting that occurs after surgery. This new medication is being compared to another intravenous medication that is already available to patients for this indication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 40 mg MK0517 IV |
|
| 2 | Active Comparator | 4 mg ondansetron IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: MK0517 | Drug | a single administration of 40 mg MK0517 by IV immediately prior to surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Clinical Adverse Experiences (CAEs) | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | Baseline and 24 hours |
| Number of Patients With Laboratory Adverse Experiences (LAEs) | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. | Baseline and 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Drug-related CAEs | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs | Baseline and 24 hours |
| Number of Patients With Serious CAEs |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
Patient is at least 18 years of age and is scheduled to undergo open abdominal surgery or vaginal hysterectomy requiring overnight hospital stay (24-hour hospital stay after end of surgery).
First Patient In: 02-Aug-2005; Last Patient Out: 29-Nov-2005; 15 study centers in the US
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MK0517 Intravenous (IV) 40 mg | On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron. |
| FG001 | Ondansetron IV 4 mg | On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MK0517 Intravenous (IV) 40 mg | On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron. Data Reported is for all all participants who received active study therapy. |
| BG001 |
| 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 | Number of Patients With Clinical Adverse Experiences (CAEs) | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | All patients as treated (APaT) which included all patients who received active study therapy. | Posted | Number | Participants | Baseline and 24 hours |
|
1-day plus 14 days post-therapy
Number of subjects at risk includes randomized subjects who had follow-up and completed the trial after at least one dose of treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK0517 Intravenous (IV) 40 mg | On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 8.1 | Non-systematic Assessment |
The formulation of MK0517 used in this study was a non polysorbate (PS80) formulation which was not further developed and is not available for use.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
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Not provided
| Comparator: ondansetron |
| Drug |
a single administration of 4 mg ondansetron by IV immediately prior to surgery |
|
|
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
| Baseline and 24 hours |
| Ondansetron IV 4 mg |
On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517. The formulation of MK0517 used in this study was a non polysorbate (PS80) formulation which was not further developed and is not available for use. Data Reported is for all all participants who received active study therapy. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517. |
|
|
| Primary | Number of Patients With Laboratory Adverse Experiences (LAEs) | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. | All patients as treated (APaT) which included all patients who received active study therapy. patients in the MK0517 40 mg treatment group were randomized but did not have at least one post-baseline laboratory test and therefore were not counted as part of the N analyzed. | Posted | Number | Participants | Baseline and 24 hours |
|
|
|
| Secondary | Number of Patients With Drug-related CAEs | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs | All patients as treated (APaT) which included all patients who received active study therapy. | Posted | Number | Participants | Baseline and 24 hours |
|
|
|
| Secondary | Number of Patients With Serious CAEs | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | All patients as treated (APaT) which included all patients who received active study therapy. | Posted | Number | Participants | Baseline and 24 hours |
|
|
|
| 15 |
| 167 |
| 124 |
| 167 |
| EG001 | Ondansetron IV 4 mg | On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517. | 3 | 44 | 31 | 44 |
| Cardiac Arrest | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Intestinal Perforation | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Pelvic Abscess | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Bladder Injury | Injury, poisoning and procedural complications | MedDRA 8.1 | Non-systematic Assessment |
|
| Post Procedural Complication | Injury, poisoning and procedural complications | MedDRA 8.1 | Non-systematic Assessment |
|
| Muscle Haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Anoxic Encephalopathy | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Pelvic Congestion | Reproductive system and breast disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Vaginal Haemorrhage | Reproductive system and breast disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Vaginal Laceration | Reproductive system and breast disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Extrasystoles | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Eye Irritation | Eye disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Eye Pain | Eye disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Chest Pain | General disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Feeling Jittery | General disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Hypothermia | General disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Infusion Site Erythema | General disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Infusion Site Induration | General disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Infusion Site Oedema | General disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Infusion Site Pain | General disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Infusion Site Reaction | General disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Fungal Rash | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Vaginal Infection | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Vulvovaginal Mycotic Infection | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Arthropod Bite | Injury, poisoning and procedural complications | MedDRA 8.1 | Non-systematic Assessment |
|
| Delayed Recovery From Anaesthesia | Injury, poisoning and procedural complications | MedDRA 8.1 | Non-systematic Assessment |
|
| Suture Rupture | Injury, poisoning and procedural complications | MedDRA 8.1 | Non-systematic Assessment |
|
| Transfusion Reaction | Injury, poisoning and procedural complications | MedDRA 8.1 | Non-systematic Assessment |
|
| Wound Complication | Injury, poisoning and procedural complications | MedDRA 8.1 | Non-systematic Assessment |
|
| Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA 8.1 | Non-systematic Assessment |
|
| Body Temperature Increased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
|
| Oxygen Saturation Decreased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
|
| Urine Output Decreased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
|
| Calcium Deficiency | Metabolism and nutrition disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Neuropathy | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Paraesthesia Oral | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Bladder Perforation | Renal and urinary disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Bladder Spasm | Renal and urinary disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Oliguria | Renal and urinary disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Pelvic Pain | Reproductive system and breast disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Vaginal Discharge | Reproductive system and breast disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Vulval Laceration | Reproductive system and breast disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Pulmonary Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Upper Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Urticari | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 8.1 | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |