An Efficacy and Safety Study of Acetaminophen Plus Tramadol Hydrochloride (JNS013) in Participants With Chronic Pain

NCT00736853 | Completed Phase 3 Results

• 3 other identifiers: CR015112JNS013-JPN-04NCT00736853
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 20

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride plus acetaminophen (JNS013) in participants with chronic pain accompanied by osteoarthritis (a progressive and degenerative joint disease, in which the joints become painful and stiff) of the knee or low back pain (acute or chronic pain in the lumbar or sacral regions) which cannot be controlled sufficiently with non-steriodal anti-inflammatory drugs (NSAIDs).

Conditions

Pain

Keywords

Chronic pain; Acetoaminophen; Tramadol; Osteoarthritis of the knee; Low back pain

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period

  The pain relief was regarded as insufficient, if either of the following was met, a) the value of average pain intensity felt in daily living during the past 24 hours (Visual analog scale 24 \[VAS24\] ) on 2 consecutive days in double-blind period worsened greater than 15 millimeter (mm) compared with the average VAS24 during 3 days before the end of open-label period, b) when the participant asked for discontinuation of treatment with the study drug because of insufficient pain relief.

  Day 28 of double-blind period

Secondary Outcomes (22)

• Change in the Visual Analog Scale for the Last 24 Hours (VAS24) Value at the Start of the Double-Blind Period From the Baseline Value at the Start of the Open-Label Period

  Day 1 of open-label period and Day 1 of double-blind period

• Change in the VAS24 Value From the Baseline at the Final Time Point of the Double-Blind Period

  Day 1 and Day 28 of double-blind period

• Mean Pain Intensity (PI) Score During Open-Label Period

  Pre-dose and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period

• Mean PI Score During Double-Blind Period

  Pre-dose and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period

• Mean Pain Intensity Difference (PID) During the Open-Label Period

  Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period

Study Arms (3)

Tramadol Hydrochloride Plus Acetaminophen (Open-Label)

EXPERIMENTAL

Drug: Tramadol Hydrochloride Plus Acetaminophen (Open-Label)

Tramadol Hydrochloride Plus Acetaminophen (Double Blind)

EXPERIMENTAL

Drug: Tramadol Hydrochloride Plus Acetaminophen (Double-Blind)

Placebo (Double-Blind)

PLACEBO COMPARATOR

Drug: Placebo (Double-Blind)

Interventions

Tramadol Hydrochloride Plus Acetaminophen (Open-Label) DRUG

Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily will be given for one week; dose level will be fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose will be 8 tablets).

Tramadol Hydrochloride Plus Acetaminophen (Open-Label)

Tramadol Hydrochloride Plus Acetaminophen (Double-Blind) DRUG

Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose \[number of tablets\] as that for the second week in the open-label period) will be given 4 times daily up to 4 weeks.

Tramadol Hydrochloride Plus Acetaminophen (Double Blind)

Placebo (Double-Blind) DRUG

Matching placebo will be given up to 4 weeks.

Placebo (Double-Blind)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with sustention of chronic pain associated with OA or LBP for at least 3 months
• Participants whose pain cannot be controlled sufficiently with at least 14-day continuous treatment with identical oral NSAIDs at a usual maximum dose during 3 months prior to this study
• Outpatients
• Ambulatory participants without need for any supportive device or assistance during daily life

You may not qualify if:

• Participants with conditions for which opioids are contraindicated
• Participants with conditions for which acetaminophen is contraindicated
• Participants with history of convulsion or the possibility of convulsive seizure
• Participants with concurrent, previous, or possible alcohol dependence, drug dependence, or narcotic addiction
• Pregnant participants or those who may be pregnant, lactating mothers, and participants who wish pregnancy during the study period

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (20)

Unknown Facility

Aichi, Japan

Location

Unknown Facility

Amagasaki, Japan

Location

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Chiba, Japan

Location

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Edogawa City, Japan

Location

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Fukuoka, Japan

Location

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Fukushima, Japan

Location

Unknown Facility

Iruma, Japan

Location

Unknown Facility

Kagoshima, Japan

Location

Unknown Facility

Kawasaki, Japan

Location

Unknown Facility

Kumagaya, Japan

Location

Unknown Facility

Kurume, Japan

Location

Unknown Facility

Meguro City, Japan

Location

Unknown Facility

Minato, Japan

Location

Unknown Facility

Niigata, Japan

Location

Unknown Facility

Ohta-Ku, Japan

Location

Unknown Facility

Okazaki, Japan

Location

Unknown Facility

Sagamihara, Japan

Location

Unknown Facility

Setagaya City, Japan

Location

Unknown Facility

Shibuya City, Japan

Location

Unknown Facility

Shinjuku-Ku, Japan

Location

Related Links

• A Phase III Study of JNS013 in Patients with Chronic Pain

MeSH Terms

Conditions

Pain; Chronic Pain; Osteoarthritis, Knee; Low Back Pain

Interventions

Tramadol; Acetaminophen; Double-Blind Method

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Back Pain

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Acetanilides; Anilides; Amides; Aniline Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Medical Director
• Organization: Neuroscience Department, Clinical Science Division, R&D, JANSSEN PHARMACEUTICAL. K.K.

+81-3-4411-5509

Study Officials

• Janssen Pharmaceutical K.K. Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 18, 2008
• Study Start: June 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: September 26, 2013
• Results First Posted: September 26, 2013

Record last verified: 2013-07

Locations

JP (20)