Pain Clinical Trial
Official title:
A Randomized, Double-Blind, Parallel-Group Study of NUCYNTA (Tapentadol) Immediate Release vs. Oxycodone Immediate Release for the Treatment of Acute Low Back Pain
Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the treatment of acute low back pain.
Status | Completed |
Enrollment | 667 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - At Visit 1 (study entry) patients must have a medical history and physical and neurological examinations that support a clinical diagnosis of acute low back pain that is felt down to the lower leg below the knee with the onset no longer than 30 days before Visit 1 - At Visit 1 patients must report qualifying pain intensity scores - Patients must be appropriate candidates for treatment with oral opioid pain medication in the investigator's clinical judgment - Patients must be able to appropriately verbalize pain characteristics and to complete all protocol required measurements/assessments without assistance - Patients must be medically stable on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening Exclusion Criteria: - History of back (cervical, thoracic or lumbosacral) pain =50% of the time in the 1 year prior to the first visit - History of any low back pain episode, with the exception of the current acute low back pain episode, within 3 months prior to the first visit that was greater than mild in pain intensity, or was associated with disability (e.g., loss of time from work, family, or activities of daily living), or necessitated the use of an opioid (narcotic) analgesic including tramadol - Medical history or physical examination results that suggest the acute low back pain or any of the neurological symptoms or signs are caused by a serious medical condition (e.g., fever, chills, unexplained weight loss, bowel or urinary bladder dysfunction or incontinence, bilateral leg weakness, progressive weakness, paralysis) - There is a high probability for surgical intervention for the back pain during the projected time on the study or that there will be an increase in the severity of the leg pain or deficits - Had either a surgical procedure involving the spine or intervertebral discs in the lower back region within 1 year prior to Visit 1 or had >1 surgical procedure(s) involving the spine or intervertebral discs in the lower back region - has any painful condition that could interfere with the study assessments or with the patient's ability to differentiate the pain associated with the acute low back pain episode from pain associated with another condition - History of severe lumbar spinal stenosis, fibromyalgia, or ankylosing spondylitis - history of epilepsy or recurrent seizures - Unable or unwilling to discontinue all prohibited medications at the time of randomization and during the time of their participation in the study - Known or suspected history of alcohol or drug abuse based on medical history, physical examination, urine drug screening, or the investigator's clinical judgment - History of cancer malignancy within 2 years prior to the first visit, with the exception of basal cell skin carcinoma - Have filed or plan to file a worker's compensation claim for any issue related to the current acute low back pain episode - Currently involved in litigation or plan to seek legal recourse for any issue related to their acute low back pain - Known allergies, hypersensitivity, or intolerance to tapentadol or the comparator (oxycodone) or any excipients used in their manufacture - Had previously been enrolled in a tapentadol clinical study - is pregnant or are breast-feeding |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ortho-McNeil Janssen Scientific Affairs, LLC | Grünenthal GmbH |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 120 Hours (With Imputation) | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 120 hours. | 0 hour (prior to first dose) and 120 hours | No |
Secondary | Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 2 Days (With Imputation) | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days. | Day 0 and Day 2 | No |
Secondary | SPID for Low Back Pain - Summary Statistics at 3 Days (With Imputation) | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days. | Day 0 and Day 3 | No |
Secondary | SPID for Low Back Pain - Summary Statistics at 10 Days (With Imputation) | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days. | Day 0 and Day 10 | No |
Secondary | SPID for Index Leg Pain - Summary Statistics at 2 Days (With Imputation) | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days. | Day 0 and Day 2 | No |
Secondary | SPID for Index Leg Pain - Summary Statistics at 3 Days (With Imputation) | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days. | Day 0 and Day 3 | No |
Secondary | SPID for Index Leg Pain - Summary Statistics at 5 Days (With Imputation) | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 5 days. | Day 0 and Day 5 | No |
Secondary | SPID for Index Leg Pain - Summary Statistics at 10 Days (With Imputation) | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days. | Day 0 and Day 10 | No |
Secondary | Total Pain Relief (TOTPAR) for Low Back Pain - Summary Statistics at 5 Days | Pain Relief - 5-Point Numerical Rating Scale, 0=None, 4=Complete. Total Pain Relief (TOTPAR) is a weighted sum of pain relieve over a specified time period, say 5 days. | Day 0 and Day 5 | No |
Secondary | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 5 | Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender. | Day 0 and Day 5 | No |
Secondary | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 10/Last Visit | Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender. | Day 0 and Day 10 | No |
Secondary | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 5 | Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing. | Day 0 and Day 5 | No |
Secondary | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 10/Last Visit | Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing. | Day 0 and Day 10 | No |
Secondary | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 5 | Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or "pins and needles" and numbness. | Day 0 and Day 5 | No |
Secondary | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 10/Last Visit | Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or "pins and needles" and numbness. | Day 0 and Day 10 | No |
Secondary | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 5 | Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel. | Day 0 and Day 5 | No |
Secondary | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 10/Last Visit | Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel. | Day 0 and Day 10 | No |
Secondary | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 5 | Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10. | Day 0 and Day 5 | No |
Secondary | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 10/Last Visit | Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10. | Day 0 and Day 10 | No |
Secondary | Patient Global Impression of Change at End of Study | Patient Global Impression of Change (PGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). | Day 0 and Day 10/last visit | No |
Secondary | Patient Global Impression of Change at End of Study | Patient Global Impression of Change (PGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). | Day 0 and Day 10/lst visit | No |
Secondary | Clinician Global Impression of Change at End of Study | Clinician Global Impression of Change (CGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). | Day 0 and Day 10/last visit | No |
Secondary | Satisfaction With Treatment at Day 5 | The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied). | Day 0 and Day 5 | No |
Secondary | Satisfaction With Treatment at End of Study | The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied). | Day 0 and Day 10/last visit | No |
Secondary | Incidence of 30% Responders Without Nausea or Vomiting at Day 5 | Number of subjects had = 30% reduction from baseline in low back pain intensity without nausea or vomiting reported. | Day 0 and Day 5 | No |
Secondary | Incidence of 50% Responders Without Nausea or Vomiting at Day 5 | Number of subjects had = 50% reduction from baseline in low back pain intensity without nausea or vomiting reported. | Day 0 and Day 5 | No |
Secondary | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | Day 0 and Day 10/last visit | No | |
Secondary | Summary of Subjects Having Nausea as a Treatment-Emergent Adverse Event | Number of subjects that reported nausea as a treatment-emergent adverse event during the study. | Day 0 and Day 10/last visit | No |
Secondary | Summary of Subjects Having Vomiting as a Treatment-Emergent Adverse Event | Number of subjects that reported vomiting as a treatment emergent adverse event during the study. | Day 0 and Day 10/last visit | No |
Secondary | Summary of Subjects Having Constipation as a Treatment-Emergent Adverse Event | Number of subjects that reported constipation as a treatment emergent adverse event during the study. | Day 0 and Day 10/last visit | No |
Secondary | Summary of Subjects Having Pruritus as a Treatment-Emergent Adverse Event | Number of subjects that reported pruritus as a treatment emergent adverse event during the study. | Day 0 and Day 10/last visit | No |
Secondary | Kaplan-Meier First Time to 30% Response From Baseline for Low Back Pain | 30% response means >= 30% reduction from baseline in low back pain intensity score. | Day 0 and Day 10/last visit | No |
Secondary | Kaplan-Meier First Time to 50% Response From Baseline for Low Back Pain | 50% response means >= 50% reduction from baseline in low back pain intensity score. | Day 0 and Day 10/last visit | No |
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