Clinical trial NCT01124604: An Efficacy and Safety Study for Tapentadol Extended Release (JNS024ER) in Chronic Pain Participants
Official title: Phase II Study of JNS024ER in Japanese Subjects With Chronic Pain Due to Osteoarthritis of the Knee or Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Low Back Pain
Back Pain
Osteoarthritis, Knee
Keywords: Pain
Low Back Pain
Back Pain
Osteoarthritis, Knee
Tapentadol
Tapentadol Hydrochloride Extended Release
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2010-05-17
Enrollment: 91
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in 11-point Numerical Rating Scale (NRS)
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
measure: Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS)
timeFrame: Week 12
measure: Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale
timeFrame: Week 8, Week 12
measure: Number of Participants With Response Based on Physician's Global Assessment Scale
timeFrame: Week 8, Week 12
measure: Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale
timeFrame: Baseline, Week 12
measure: Number of Participants With 50 Percent Pain Relief Based on Brief Pain Inventory-Short Form (BPI-sf) Scale
timeFrame: Baseline, Week 12
measure: Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Total Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants With Awakenings Based on Sleep Questionnaire
timeFrame: Baseline, Week 12
measure: Number of Participants With Response Based on Overall Quality of Sleep Questionnaire
timeFrame: Baseline, Week 12
measure: Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Western Ontario MacMaster Questionnaire (WOMAC) Global Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Score at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
measure: Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS)
timeFrame: Week 12
measure: Serum Concentration of Tapentadol
timeFrame: Week 2, 4, 8, 12
Locations:
city: Aichi
country: Japan
city: Amagasaki
country: Japan
city: Chiba N/A
country: Japan
city: Chiba
country: Japan
city: Chikushi
country: Japan
city: Edogawa
country: Japan
city: Fukuoka
country: Japan
city: Fukushima
country: Japan
city: Hiratsuka
country: Japan
city: Kawasaki
country: Japan
city: Koto
country: Japan
city: Matsudo
country: Japan
city: Meguro
country: Japan
city: Minato-Ku
country: Japan
city: Niigata N/A
country: Japan
city: Niigata
country: Japan
city: Osaka
country: Japan
city: Sagamihara
country: Japan
city: Shibuya
country: Japan
city: Shinjuku-Ku
country: Japan
city: Toshima-Ku
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K. Clinical Trial
role: STUDY_DIRECTOR
References: