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
This is an emergency department based randomized study of oxycodone/ acetaminophen versus acetaminophen alone for patients with acute musculoskeletal pain refractory to ibuprofen
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen | Active Comparator | Acetaminophen alone |
|
| Oxycodone/ acetaminophen | Active Comparator | Oxycodone + acetaminophen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | Acetaminophen 650mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Assessment | Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): Change in Pain Assessment from baseline was determined using the Numeric Rating Scale (NRS) for evaluating pain. The rating was verbalized, and the subject was asked to estimate current pain intensity on an 11-point scale, where 0 indicated no pain at all and 10 indicated the worst imaginable pain. Positive mean changes in NRS scores were associated with increased pain relief. | 2 hours following treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Pain Relief | Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): Sustained pain relief was determined using a four-item ordinal scale. The rating was verbal and the subject was asked to describe their level of pain within two hours of medication administration and maintaining this level, without rescue medication, for 48 hours. The patients used the following descriptors: severe, moderate, mild, or none. For reporting responses of 'mild' and 'none' were aggregated into a single category and 'moderate' and severe' were aggregated into a separate category. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
During enrollment into Stage 1 (ibuprofen open label stage), 924 patients were screened for participation and 393 were enrolled. Of the 393, a total of 159 reported insufficient relief of pain from ibuprofen and requested more medication to treat the pain. Five patients who met criteria to progress to the randomized stage withdrew of their own volition. As such, 154 patients progressed to Stage 2. 77 were randomized to oxycodone/acetaminophen and 77 were randomized to acetaminophen alone.
Enrollment into Stage 1 (open label stage) commenced on December 2019 in two urban emergency departments in Bronx, NY. Enrollment was halted from March-June 2020 due to COVID-19, and then resumed and concluded October 2020.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Acetaminophen | Acetaminophen alone (Stage 2, Double blinded) Acetaminophen: Acetaminophen 650mg PO |
| FG001 | Oxycodone/Acetaminophen | Oxycodone + Acetaminophen (Stage 2, Double blinded) Acetaminophen: Acetaminophen 650mg PO Oxycodone: Oxycodone 10mg PO |
| FG002 | Ibuprofen | Ibuprofen - 600mg PO (Stage 1, Open label) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 - Open Label |
|
| |||||||||||||||||||||
| Stage 2 - Double Blinded |
|
393 patients were enrolled into Stage 1 (Ibuprofen open label stage). 154 patients progressed to Stage 2 (two-arm, double blinded) of the study. An analysis of baseline characteristics inclusive of only the 239 Stage 1 participants was not conducted. As such, Age, Sex/Gender, and Pain Assessment baseline data representing only Stage 1 participants is not available.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ibuprofen + Acetaminophen | Acetaminophen alone (Stage 2, Double blinded) Acetaminophen: Acetaminophen 650mg PO |
| BG001 | Ibuprofen + Oxycodone/Acetaminophen | Oxycodone + Acetaminophen (Stage 2, Double blinded) Acetaminophen: Acetaminophen 650mg PO Oxycodone: Oxycodone 10mg PO |
| 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 | Change in Pain Assessment | Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): Change in Pain Assessment from baseline was determined using the Numeric Rating Scale (NRS) for evaluating pain. The rating was verbalized, and the subject was asked to estimate current pain intensity on an 11-point scale, where 0 indicated no pain at all and 10 indicated the worst imaginable pain. Positive mean changes in NRS scores were associated with increased pain relief. | Posted | Mean | Standard Deviation | score on a scale | 2 hours following treatment |
|
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events
Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
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 | Ibuprofen and Then Acetaminophen (Stage 2) | Ibuprofen - 600mg PO (Stage 1, Open label) Acetaminophen alone (Stage 2, Double blinded) Acetaminophen: Acetaminophen 650mg PO |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin Friedman | Montefiore Medical Center | 718-920-6626 | befriedm@montefiore.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2019 | Nov 30, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oxycodone |
| Drug |
Oxycodone 10mg |
|
| Up to 48 hours following medication administration |
| Adequacy of Analgesia | Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): Adequacy of analgesia was determined by querying the participants by asking a single question: "Did the medication provided control your pain?" Answer choices: Yes (it did); No (It did not); and Unsure. The number of participants responses were summarized by category. | 2 hours following treatment |
| Satisfaction With Medication | Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): The number of participants demonstrating satisfaction with medication was determined by asking participants if the same medication regimen would be desired during a subsequent episode of pain. Possible responses included "Yes", "No" or "Unsure" | 2 hours following treatment |
| Medication-related Adverse Events | Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): The number of participants demonstrating medication-related adverse events was tabulated by treatment arm/group. | 2 hours following treatment |
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pain Assessment | Baseline Pain Assessment was determined using the Numeric Rating Scale (NRS) for evaluating pain. The rating was verbalized, and the subject was asked to estimate current pain intensity on an 11-point scale, where 0 indicated no pain at all and 10 indicated the worst imaginable pain. Higher scores were indicative of greater pain intensity. | Mean | Standard Deviation | score on a scale |
|
Ibuprofen - 600mg PO (Stage 1, Open label) Oxycodone + Acetaminophen (Stage 2, Double blinded) Acetaminophen: Acetaminophen 650mg PO Oxycodone: Oxycodone 10mg PO |
|
|
|
| Secondary | Sustained Pain Relief | Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): Sustained pain relief was determined using a four-item ordinal scale. The rating was verbal and the subject was asked to describe their level of pain within two hours of medication administration and maintaining this level, without rescue medication, for 48 hours. The patients used the following descriptors: severe, moderate, mild, or none. For reporting responses of 'mild' and 'none' were aggregated into a single category and 'moderate' and severe' were aggregated into a separate category. | Posted | Number | participants | Up to 48 hours following medication administration |
|
|
|
|
| Secondary | Adequacy of Analgesia | Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): Adequacy of analgesia was determined by querying the participants by asking a single question: "Did the medication provided control your pain?" Answer choices: Yes (it did); No (It did not); and Unsure. The number of participants responses were summarized by category. | Responses for 3 participants in the 'Acetaminophen' arm and 1 participant in the 'Oxycodone + Acetaminophen' arm were unavailable. | Posted | Count of Participants | Participants | 2 hours following treatment |
|
|
|
|
| Secondary | Satisfaction With Medication | Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): The number of participants demonstrating satisfaction with medication was determined by asking participants if the same medication regimen would be desired during a subsequent episode of pain. Possible responses included "Yes", "No" or "Unsure" | Responses for 4 participants in the 'Acetaminophen' arm and 1 participant in the 'Oxycodone + Acetaminophen' arm were unavailable. | Posted | Count of Participants | Participants | 2 hours following treatment |
|
|
|
|
| Secondary | Medication-related Adverse Events | Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): The number of participants demonstrating medication-related adverse events was tabulated by treatment arm/group. | Responses for 3 participants in the 'Acetaminophen' arm and 1 participant in the 'Oxycodone + Acetaminophen' arm were unavailable. | Posted | Count of Participants | Participants | 2 hours following treatment |
|
|
|
| 0 |
| 74 |
| 0 |
| 74 |
| 6 |
| 74 |
| EG001 | Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2) | Ibuprofen - 600mg PO (Stage 1, Open label) Oxycodone + Acetaminophen (Stage 2, Double blinded) Acetaminophen: Acetaminophen 650mg PO Oxycodone: Oxycodone 10mg PO | 0 | 76 | 0 | 76 | 18 | 76 |
| EG002 | Ibuprofen (Stage 1) | Ibuprofen - 600mg PO (Stage 1, Open label) | 0 | 0 | 0 | 0 | 0 | 0 |
| Drowsiness | Nervous system disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Itchiness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | Non-systematic Assessment |
|
| Shakiness | Nervous system disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D003061 | Codeine |
| 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 |
| Unsure |
|
| Unsure |
|