A Long-term Efficacy and Safety Study of Tramadol Hydrochloride Plus Acetaminophen (JNS013) in Japanese Participants With Chronic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT00736957
First received: August 14, 2008
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride plus acetaminophen (JNS013) with long term administration in participants with chronic pain.


Condition Intervention Phase
Chronic Pain
Drug: Tramadol Hydrochloride (HCL) plus Acetaminophen (JNS013)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of a Long-term Administration of JNS013 in Patients With Chronic Pain

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change From Baseline in Visual Analogue Scale (VAS24) Score at Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    Pain over the last 24 hours was assessed by using VAS score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.

  • Change From Baseline in VAS24 Score at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.


Secondary Outcome Measures:
  • Number of Participants With Improvement From Baseline in VAS24 Score [ Time Frame: Week 4 and 52 ] [ Designated as safety issue: No ]
    Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.

  • Pain Intensity Difference (PID) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    PID is defined as the amount of change in the pain intensity at each evaluation time point (at 2 and 4 hours after the study drug dosing) from the baseline for each participant. Pain Intensity was evaluated on a 4-stage scale ranging from 3=severe pain to 0=no pain. PID ranges from -3 (the worst) to +3 (the most improved).

  • Pain Relief (PAR) Score at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Pain relief was evaluated based on a 5-stage scale from 4 (complete relief) to 0 (no relief). An increase in score represented improvement and decrease represented disease progression

  • Pain Relief Combined With Pain Intensity Difference (PRID) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    PRID was sum of the PID and PAR for each participant at each evaluation time point (2 hours after dosing, 4 hours after dosing). Pain Intensity was evaluated on a 4-stage scale ranges from 3=severe pain to 0=no pain and PID ranges from -3 (the worst) to +3 (the most improved). PAR ranges from 0 (no improved) to +4 (the most improved). PRID ranges from -3 (the worst) to +7 (the most improved).

  • Change From Baseline in Short Form-36 (SF-36) Score [ Time Frame: Baseline, Week 4 and 52 ] [ Designated as safety issue: No ]
    SF-36 is a metric for general health and Quality of Life (QOL), consists of 8 sub-scale indices related to health and QOL (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health). Each of the sub-scale scores ranged from 0 to 100, where higher values indicate a better health status or a better mental status.


Enrollment: 219
Study Start Date: May 2008
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tramadol HCL plus Acetaminophen Drug: Tramadol Hydrochloride (HCL) plus Acetaminophen (JNS013)
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets will be given orally four times daily (maximum dose is 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments will be established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval will be of at least 4 hours.

Detailed Description:

This is an open-label (both physician and participant know the name of the study drug), non-randomized, multicenter (when more than one hospital or medical school team work on a medical research study) and long-term efficacy and safety study of JNS013 (combination of tramadol hydrochloride (TRAM) with acetaminophen [APAP]) in participants with chronic pain (aching sensation that persists for more than a few months. It may or may not be associated with trauma or disease, and may persist after the initial injury has healed. Its localization, character, and timing are more vague than with acute pain). This study consists of 4 periods; screening period: 1 week, treatment period I: 4 weeks, treatment period II: 48 weeks and follow-up period: 1 week. During Treatment Period I, restrictions on concomitant treatments will be established and the participants will be treated with one or two tablets of JNS013, four times daily for four weeks. During Treatment Period II, the participants will be treated for 48 weeks using the same dosing method and dose level for JNS013 as was used during Treatment Period I, permitting modifications to the concomitant drugs/therapies as during normal medical care. Throughout both Treatment Period I and Treatment Period II, the decision will be made to permit the participants to select to use either one or two tablets of JNS013 per dose according to the extent of the participant's pain and tolerability. The total duration of treatment period will be of 52 weeks. Efficacy will be assessed using change from baseline in Visual Analogue Scale for pain (VAS24) score at the pre-defined time point until Week 52. 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 whose pain cannot be controlled sufficiently with at least 14-day continuous treatment with identical oral non steroid anti inflammatory drugs (NSAIDs) at a usual maximum dose during 3 months prior to this study
  • Ambulatory participants without need for any supportive device or assistance during daily life
  • Outpatients
  • Participants who do not plan to change the therapeutic policy and content of the medications for underlying disease during screening period to the end of Treatment Period I
  • Sustention of chronic pain due to Osteo Arthritis (OA), Low Back Pain (LBP), Rheumatoid Arthritis (RA), Neck Shoulder Arm Syndrome (NSAS), Diabetic Neuropathy (DN), Post herpetic Neuralgia (PHN) or other for at least 3 months

Exclusion Criteria:

  • Participants with conditions for which opioids are contraindicated
  • Participants with conditions for which APAP are 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.
  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: NCT00736957

Locations
Japan
Chikushi, Japan
Chuo, Japan
Fukui, Japan
Fukuoka, Japan
Hiratsuka, Japan
Ichikawa, Japan
Kashiwa, Japan
Komatsu, Japan
Kuki, Japan
Kumamoto, Japan
Kyoto, Japan
Mihara, Japan
Nagoya, Japan
Nerima, Japan
Obihiro, Japan
Ogi, Japan
Ohta-Ku, Japan
Osaka, Japan
Tagawa, Japan
Taito-Ku, Japan
Takaoka, Japan
Tokyo, Japan
Tokyo N/A, Japan
Urayasu, Japan
Yame, Japan
Yokohama, 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: NCT00736957     History of Changes
Other Study ID Numbers: CR015115, JNS013-JPN-05
Study First Received: August 14, 2008
Results First Received: March 25, 2013
Last Updated: June 23, 2014
Health Authority: Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Janssen Pharmaceutical K.K.:
Chronic Pain
Acetaminophen
Tramadol
JNS013

Additional relevant MeSH terms:
Acetaminophen
Tramadol
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotics
Central Nervous System Depressants
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 22, 2014