An Efficacy and Safety Study for Tapentadol Extended Release (JNS024ER) in Chronic Pain Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT01124604
First received: April 22, 2010
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to evaluate the efficacy, safety and to explore the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of tapentadol hydrochloride extended release (ER) tablets in Japanese participants with moderate to severe chronic pain due to osteoarthritis (disorder in which the joints become painful and stiff) of knee or low back pain.


Condition Intervention Phase
Pain
Low Back Pain
Back Pain
Osteoarthritis, Knee
Drug: Tapentadol Hydrochloride
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Study of JNS024ER in Japanese Subjects With Chronic Pain Due to Osteoarthritis of the Knee or Low Back Pain

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.


Secondary Outcome Measures:
  • Change From Baseline in 11-point Numerical Rating Scale (NRS) [ Time Frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 ] [ Designated as safety issue: No ]
    Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.

  • Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Percentage of participants with improvement in mean NRS score by greater than or equal to 30 percent or 50 percent in the last week from Baseline were considered as responders. Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale.

  • Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale [ Time Frame: Week 8, Week 12 ] [ Designated as safety issue: No ]
    The PGIC is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a Baseline state at the beginning of the intervention. The response options are 1 = very much improved, 2 = much improved, 3 = minimally improve, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.

  • Number of Participants With Response Based on Physician's Global Assessment Scale [ Time Frame: Week 8, Week 12 ] [ Designated as safety issue: No ]
    Physician's Global Assessment Scale assesses the therapeutic efficacy (effectiveness) of the study drug for pain control on a 2-point scale of "effective" and "not effective".

  • Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    BPI-sf is a self-evaluated pain assessment form consisting of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Item 1 for presence of pain assesses the question: "Do you have any pain today other than everyday kinds of pain?" on a 2-point scale of "yes" or "no".

  • Number of Participants With 50 Percent Pain Relief Based on Brief Pain Inventory-Short Form (BPI-sf) Scale [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    BPI-sf is a self-evaluated pain assessment form consisting of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Item 8 for efficacy of pain treatment assesses number of participants with at least 50 percent pain relief during the last 24 hours on a scale ranging from 0 percent (no relief) to 100 percent (complete relief).

  • Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Total Score at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    BPI-sf consists of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Total score is defined as the mean scores from items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Negative change indicates an improvement in pain.

  • Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Sleep Latency was addressed by the question: "How long after bedtime/lights out did you fall asleep last night?" and the change from Baseline in sleep latency was reported. Decrease in time indicated improvement.

  • Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Time slept was addressed by the question: "How long did you sleep last night?" and the change from Baseline in time slept was reported.

  • Number of Participants With Awakenings Based on Sleep Questionnaire [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Number of awakenings was addressed by the question: "How many times did you wake up during the night?'' and lesser number signified better sleep.

  • Number of Participants With Response Based on Overall Quality of Sleep Questionnaire [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Overall quality of sleep was addressed by the question: "Please rate the overall quality of your sleep last night" and participants could choose one of the following options: excellent, good, fair or poor.

  • Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.

  • Change From Baseline in Western Ontario MacMaster Questionnaire (WOMAC) Global Score at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    WOMAC is a self administered 24-item questionnaire used to evaluate participants with osteoarthritis of the knee. It consists of 3 subscales: pain (5 items), joint stiffness (2 items), and physical function (17 items). Each item is assessed on a 5-point scale from 0 to 4. The global score assesses pain, disability and joint stiffness and ranges from 0 to 96. Higher scores indicate that a symptom is bothersome and physically disabling.

  • Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Score at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    RDQ scale is used to assess the impact of low back pain on daily activities by participants. The scale consists of 24 item questionnaire with options as "Yes"/"No" where "Yes" is counted as 1 point. The total score ranged from 0 to 24, with higher scores indicating greater disability.


Other Outcome Measures:
  • Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS) [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
    COWS is an 11-item questionnaire for clinical assessment of withdrawal symptoms. Total score is calculated by adding the scores of all the 11-items. The severity of withdrawal symptoms is categorized using values of total score as: 0-4 = no withdrawal, 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, and 37-48 = severe withdrawal.

  • Serum Concentration of Tapentadol [ Time Frame: Week 2, 4, 8, 12 ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: April 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tapentadol Hydrochloride Drug: Tapentadol Hydrochloride
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion.
Placebo Comparator: Placebo Drug: Placebo
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion.

Detailed Description:

This is a randomized (study drug assigned by chance), multi-center (when more than one hospital or medical school team works on a medical research study), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-control (participants are randomly assigned to a test treatment or to an identical-appearing treatment that does not contain the test drug), parallel-group (each group of participants will be treated at the same time) comparison study in participants with chronic pain due to osteoarthritis of knee or low back pain. The study duration will be of 14 weeks, which consists of a screening period of 1 week during which the participants will be evaluated for study eligibility, a treatment period of 12 weeks and a follow-up period of 1 week. The treatment period will consist of titration period (from the initiation of the study treatment to determination of the individual's maintenance dose) and maintenance period (from completion of the titration period to the completion of the treatment period). An optimal dose (maintenance dose) will be determined for each participant during the titration period and the treatment will be continued at the maintenance dose to assess the efficacy and safety. Tapentadol hydrochloride ER tablets 25 to 250 milligram or placebo will be administered orally twice daily. Efficacy and safety of the participants will primarily be evaluated by change from baseline in average pain intensity score based on 11-point Numerical Rating Scale (NRS) and Clinical Opiate Withdrawal Scale (COWS), respectively. Participants' safety will be monitored throughout the study.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with chronic pain due to osteoarthritis of knee or low back pain continuing for at least 12 weeks before informed consent
  • Participants who did not achieve adequate analgesia (pain control) with routine treatment with an oral non-opioid analgesic (drug used to control pain) at its usual upper-limit dose or at an adequate fixed dose for at least 14 consecutive days during the 12 weeks before informed consent
  • Participants who have not experienced treatment with conventional opioids, except for short term use of opioid analgesics for treatment of post-operative acute pain more than 30 days before consent or temporary use of codeine phosphate or dihydrocodeine phosphate for purposes other than pain relief (e.g. for antitussive) more than 2 days before informed consent
  • Participants with average pain intensity score of greater than or equal to 5 on an 11-point Numerical Rating Scale (NRS) during 48 hours before informed consent and are considered requiring opioid treatment by the Investigator
  • Participants who are able to visit the medical institutions throughout the study period

Exclusion Criteria:

  • Participants who are taking a monoamine oxidase inhibitor within 14 days before informed consent
  • Participants with current or a history of epilepsy or seizure disorders
  • Participants suspected with intracranial hypertension (e.g. traumatic encephalopathy)
  • Participants with uncontrolled or clinically significant arrhythmia (irregular heart rate)
  • Participants with moderate to severe liver dysfunction or severe renal dysfunction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124604

Locations
Japan
Aichi, Japan
Amagasaki, Japan
Chiba, Japan
Chiba N/A, Japan
Chikushi, Japan
Edogawa, Japan
Fukuoka, Japan
Fukushima, Japan
Hiratsuka, Japan
Kawasaki, Japan
Koto, Japan
Matsudo, Japan
Meguro, Japan
Minato-Ku, Japan
Niigata, Japan
Niigata N/A, Japan
Osaka, Japan
Sagamihara, Japan
Shibuya, Japan
Shinjuku-Ku, Japan
Toshima-Ku, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K. Clinical Trial Janssen Pharmaceutical K.K.
  More Information

No publications provided

Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01124604     History of Changes
Other Study ID Numbers: CR016999, JNS024ER-JPN-N21
Study First Received: April 22, 2010
Results First Received: March 6, 2013
Last Updated: May 10, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Janssen Pharmaceutical K.K.:
Pain
Low Back Pain
Back Pain
Osteoarthritis, Knee
Tapentadol
Tapentadol Hydrochloride Extended Release

Additional relevant MeSH terms:
Osteoarthritis
Back Pain
Low Back Pain
Chronic Pain
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014