Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate two experimental pain models to see if they would be useful for comparing different products for reduction in pain intensity.
The models evaluated were the ultraviolet-B (UVB) burn and intradermal capsaicin experimental pain models. Medications compared were a single dose each, of intravenous (IV) acetaminophen, oral acetaminophen, placebo, and IV morphine.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Acetaminophen | Experimental | All participants receive IV acetaminophen as one of 4 interventions in random sequence |
|
| Oral Acetaminophen | Experimental | All participants receive oral acetaminophen as one of 4 interventions in random sequence |
|
| Placebo | Experimental | All participants receive placebo as one of 4 interventions in random sequence |
|
| Morphine | Experimental | All participants receive morphine as one of 4 interventions in random sequence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Acetaminophen (Treatment A) | Drug | Acetaminophen administered by intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Change From Baseline in Pain Intensity at Hour 6 Using the Thermal Suprathreshold Pain in the Ultraviolet-B (UVB) Burn Pain Model | The UVB burn pain model is a validated screening tool for pain killers in clinical drug development. A temperature of 50 degrees centigrade (°C) is used to burn the participant for 5 seconds. Then the participant rates his pain on a scale from 0 (no pain) to 10 (most intense pain). That score is recorded as baseline. Then the participant rates his pain again six hours after taking the assigned medication. The average at baseline is subtracted from the average at hour 6. Because this is a measure of reduction in pain intensity, a higher score is better (it means there is more pain relief). | within 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area | Participants rated their pain intensity on a scale of 0 (no pain) to 10 (most intense pain). The observed mean and standard deviation are disclosed through Hour 6 | within 6 hours |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Mallinckrodt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaceuticals Research Associates, Inc. (PRA) | Salt Lake City | Utah | 84106 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
One participant in Part 2 was randomized but discontinued without receiving treatment due to an adverse event.
A total of 79 participants were enrolled in the study. 12 participants in Part 1 and 66 participants in Part 2 were randomized to sequence, and received at least one dose of the study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 | All participants receive all products in random sequence |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 |
|
| |||||||||||||||||||||||||||
| Part 2 |
|
Safety Population, defined as participants enrolled in the study that received any quantity of study drugs. All new participants were enrolled in Part 2.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 | All participants who received a drug product in Part 1 |
| BG001 | Part 2 | All participants who received a drug product in Part 2 |
| 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 | Part 1: Change From Baseline in Pain Intensity at Hour 6 Using the Thermal Suprathreshold Pain in the Ultraviolet-B (UVB) Burn Pain Model | The UVB burn pain model is a validated screening tool for pain killers in clinical drug development. A temperature of 50 degrees centigrade (°C) is used to burn the participant for 5 seconds. Then the participant rates his pain on a scale from 0 (no pain) to 10 (most intense pain). That score is recorded as baseline. Then the participant rates his pain again six hours after taking the assigned medication. The average at baseline is subtracted from the average at hour 6. Because this is a measure of reduction in pain intensity, a higher score is better (it means there is more pain relief). | Completers, defined as participants who were enrolled in the study, took the entire dose of all study drugs, and provided all pain intensity assessments. | Posted | Mean | Standard Deviation | score on a scale | within 6 hours |
|
From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
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 | Part 1: IV Acetaminophen | All participants received IV acetaminophen | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Mallinckrodt Pharmaceuticals | 800-556-3314 | 5 | clinicaltrials@mnk.com |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oral Acetaminophen (Treatment B) | Drug | Acetaminophen administered by oral tablets |
|
|
| Placebo (Treatment C) | Drug | Placebo administered by IV infusion or oral tablets |
|
|
| Morphine (Treatment D) | Other | Morphine administered by IV infusion |
|
|
| Pharmacokinetic Population |
|
| Per Protocol Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
All participants received IV acetaminophen |
| OG001 | Oral Acetaminophen | All participants received oral acetaminophen |
| OG002 | Placebo | All participants received placebo |
| OG003 | Morphine | All participants received morphine |
|
|
| Secondary | Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area | Participants rated their pain intensity on a scale of 0 (no pain) to 10 (most intense pain). The observed mean and standard deviation are disclosed through Hour 6 | Per-Protocol Population, defined as participants who were enrolled in the study, have taken the entire dose of all study drugs, and provided all pain intensity assessments designed for the UVB Burn Pain Model without a major protocol deviation. | Posted | Mean | Standard Deviation | scores on a scale | within 6 hours |
|
|
|
| 12 |
| 0 |
| 12 |
| 2 |
| 12 |
| EG001 | Part 1: Oral Acetaminophen | All participants received oral acetaminophen | 0 | 12 | 0 | 12 | 2 | 12 |
| EG002 | Part 1: Placebo | All participants received placebo | 0 | 12 | 0 | 12 | 4 | 12 |
| EG003 | Part 1: Morphine | All participants received morphine | 0 | 12 | 0 | 12 | 8 | 12 |
| EG004 | Part 2: IV Acetaminophen | All participants received IV acetaminophen | 0 | 64 | 0 | 64 | 10 | 64 |
| EG005 | Part 2: Oral Acetaminophen | All participants received oral acetaminophen | 0 | 65 | 0 | 65 | 12 | 65 |
| EG006 | Part 2: Placebo | All participants received placebo | 0 | 65 | 0 | 65 | 14 | 65 |
| EG007 | Part 2: Morphine | All participants received morphine | 0 | 64 | 0 | 64 | 38 | 66 |
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
|
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Axillary Pain | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Injection Site Reaction | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abnormal Dreams | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Head Discomfort | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Feeling Of Relaxations | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Eye Movement Disorder | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA (18.1) | Systematic Assessment |
|
| Altered visual depth perception | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Sensitivity of teeth | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Injection site rash | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Thirst | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Muscle fatigue | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
|
| Testicular pain | Reproductive system and breast disorders | MedDRA (18.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
Investigators will be part of the primary publication. Each investigator may publish on the data from subjects enrolled at their site after the initial publication has been submitted.
| Aniline Compounds |
| D000588 | Amines |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| 0.25 Hours |
|
| 0.5 Hours |
|
| 0.75 Hours |
|
| 1 Hour |
|
| 2 Hours |
|
| 3 Hours |
|
| 4 Hours |
|
| 6 Hours |
|