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

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ClinicalTrials.gov Identifier: NCT00736957
Recruitment Status : Completed
First Posted : August 18, 2008
Results First Posted : June 20, 2013
Last Update Posted : July 2, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Pain
Intervention Drug: Tramadol Hydrochloride (HCL) plus Acetaminophen (JNS013)
Enrollment 219
Recruitment Details  
Pre-assignment Details 219 participants were enrolled in this study out of which 29 participants did not meet the criteria to transfer to treatment period 1.
Arm/Group Title Tramadol Hydrochloride Plus Acetaminophen (JNS013)
Hide Arm/Group Description Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
Period Title: Overall Study
Started 219
Treated 190
Completed 97
Not Completed 122
Reason Not Completed
Adverse Event             43
Withdrawal by Subject             49
violation of eligibility criteria             2
did not attend hospital appointments             1
not eligible for Treatment Period I             22
Physician Decision             5
Arm/Group Title Tramadol Hydrochloride Plus Acetaminophen (JNS013)
Hide Arm/Group Description Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
Overall Number of Baseline Participants 190
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 190 participants
64.3  (12.9)
[1]
Measure Description: Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants
Female
106
  55.8%
Male
84
  44.2%
[1]
Measure Description: Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment.
1.Primary Outcome
Title Change From Baseline in Visual Analogue Scale (VAS24) Score at Week 4
Hide Description 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.
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment.
Arm/Group Title Tramadol Hydrochloride Plus Acetaminophen (JNS013)
Hide Arm/Group Description:
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
Overall Number of Participants Analyzed 190
Mean (Standard Deviation)
Unit of Measure: millimeter
Baseline 65.80  (11.629)
Change at Week 4 -22.28  (21.189)
2.Primary Outcome
Title Change From Baseline in VAS24 Score at Week 52
Hide Description 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.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment.
Arm/Group Title Tramadol Hydrochloride Plus Acetaminophen (JNS013)
Hide Arm/Group Description:
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
Overall Number of Participants Analyzed 190
Mean (Standard Deviation)
Unit of Measure: millimeter
Baseline 65.80  (11.629)
Change at Week 52 -36.54  (21.936)
3.Secondary Outcome
Title Number of Participants With Improvement From Baseline in VAS24 Score
Hide Description 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.
Time Frame Week 4 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Last Observation Carried Forward (LOCF) method was used.
Arm/Group Title Tramadol Hydrochloride Plus Acetaminophen (JNS013)
Hide Arm/Group Description:
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
Overall Number of Participants Analyzed 190
Measure Type: Number
Unit of Measure: participants
Improvement of 30 percent or more at Week 4 76
Improvement of 50 percent or more at Week 4 51
Improvement of 30 percent or more at Week 52 110
Improvement of 50 percent or more at Week 52 77
4.Secondary Outcome
Title Pain Intensity Difference (PID) at Week 4
Hide Description 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).
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Participants showing a Pain Intensity (PI) value of 0 prior to dosing at each evaluation time point were not included in the analysis.
Arm/Group Title Tramadol Hydrochloride Plus Acetaminophen (JNS013)
Hide Arm/Group Description:
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
Overall Number of Participants Analyzed 135
Mean (Standard Deviation)
Unit of Measure: units on a scale
2 hours after dosing at Week 4 0.1  (0.35)
4 hours after dosing at Week 4 0.1  (0.44)
5.Secondary Outcome
Title Pain Relief (PAR) Score at Week 4
Hide Description 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
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Participants showing a Pain Intensity (PI) value of 0 prior to dosing at each evaluation time point were not included in the analysis.
Arm/Group Title Tramadol Hydrochloride Plus Acetaminophen (JNS013)
Hide Arm/Group Description:
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
Overall Number of Participants Analyzed 135
Mean (Standard Deviation)
Unit of Measure: units on a scale
2 hours after dosing at Week 4 1.3  (0.91)
4 hours after dosing at Week 4 1.3  (0.99)
6.Secondary Outcome
Title Pain Relief Combined With Pain Intensity Difference (PRID) at Week 4
Hide Description 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).
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Participants showing a Pain Intensity (PI) value of 0 prior to dosing at each evaluation time point were not included in the analysis.
Arm/Group Title Tramadol Hydrochloride Plus Acetaminophen (JNS013)
Hide Arm/Group Description:
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
Overall Number of Participants Analyzed 135
Mean (Standard Deviation)
Unit of Measure: units on scale
2 hours after dosing at Week 4 1.3  (1.06)
4 hours after dosing at Week 4 1.4  (1.20)
7.Secondary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Score
Hide Description 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.
Time Frame Baseline, Week 4 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure and n = the number of participants with measurements for that time point.
Arm/Group Title Tramadol Hydrochloride Plus Acetaminophen (JNS013)
Hide Arm/Group Description:
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
Overall Number of Participants Analyzed 190
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical functioning:Baseline 33.7  (17.03)
Physical functioning:Change at Week 4 (n=150) 2.9  (9.06)
Physical functioning:Change at Week 52 (n=96) 4.1  (12.00)
Role-physical:Baseline 35.0  (15.43)
Role-physical:Change at Week 4 (n=150) 3.2  (11.51)
Role-physical:Change at Week 52 (n=96) 6.0  (13.76)
Bodily pain:Baseline 33.7  (6.70)
Bodily pain:Change at Week 4 (n=150) 5.5  (7.12)
Bodily pain:Change at Week 52 (n=96) 9.0  (8.74)
General health:Baseline 42.1  (10.42)
General health:Change at Week 4 (n=150) 1.5  (7.74)
General health:Change at Week 52 (n=96) 3.9  (8.92)
Vitality:Baseline 44.0  (9.82)
Vitality:Change at Week 4 (n=150) 2.1  (8.37)
Vitality:Change at Week 52 (n=96) 4.9  (9.38)
Social functioning:Baseline 41.0  (13.61)
Social functioning:Change at Week 4 (n=150) 2.7  (11.36)
Social functioning:Change at Week 52 (n=96) 6.0  (11.57)
Role-emotional:Baseline 39.4  (14.97)
Role-emotional:Change at Week 4 (n=150) 2.6  (12.43)
Role-emotional:Change at Week 52 (n=96) 5.2  (14.44)
Mental health:Baseline 43.9  (11.50)
Mental health:Change at Week 4 (n=150) 2.5  (8.73)
Mental health:Change at Week 52 (n=96) 5.5  (10.11)
Time Frame From signing of informed consent until study completion (up to 54 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tramadol Hydrochloride Plus Acetaminophen (JNS013)
Hide Arm/Group Description Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
All-Cause Mortality
Tramadol Hydrochloride Plus Acetaminophen (JNS013)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tramadol Hydrochloride Plus Acetaminophen (JNS013)
Affected / at Risk (%)
Total   24/190 (12.63%) 
Cardiac disorders   
Prinzmetal’s angina * 1  1/190 (0.53%) 
Ear and labyrinth disorders   
Sudden deafness * 1  1/190 (0.53%) 
Gastrointestinal disorders   
Vomiting * 1  3/190 (1.58%) 
Colon polyps * 1  2/190 (1.05%) 
Nausea * 1  2/190 (1.05%) 
Ileus * 1  1/190 (0.53%) 
Melena * 1  1/190 (0.53%) 
Upper gastrointestinal tract hemorrhage * 1  1/190 (0.53%) 
Infections and infestations   
Bronchitis * 1  1/190 (0.53%) 
Gastroenteritis * 1  1/190 (0.53%) 
Pyelonephritis * 1  1/190 (0.53%) 
Injury, poisoning and procedural complications   
Fall/tumble * 1  1/190 (0.53%) 
Open fracture * 1  1/190 (0.53%) 
Subdural hematoma * 1  1/190 (0.53%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/190 (0.53%) 
Lumbar spinal canal stenosis * 1  1/190 (0.53%) 
Osteonecrosis * 1  1/190 (0.53%) 
Rheumatoid arthritis * 1  1/190 (0.53%) 
Ossification of the spinal ligaments * 1  1/190 (0.53%) 
Nervous system disorders   
Cerebral infarction * 1  1/190 (0.53%) 
Diabetic autonomic nerve neuropathy * 1  1/190 (0.53%) 
Dizziness * 1  1/190 (0.53%) 
Loss of consciousness * 1  1/190 (0.53%) 
Renal and urinary disorders   
Ureteral calculus * 1  1/190 (0.53%) 
Dysuria * 1  1/190 (0.53%) 
Ureteropathy * 1  1/190 (0.53%) 
Vascular disorders   
Arteriosclerosis obliterans * 1  1/190 (0.53%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA/J V11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tramadol Hydrochloride Plus Acetaminophen (JNS013)
Affected / at Risk (%)
Total   189/190 (99.47%) 
Blood and lymphatic system disorders   
Anaemia * 1  7/190 (3.68%) 
Cardiac disorders   
Palpitations * 1  4/190 (2.11%) 
Angina pectoris * 1  1/190 (0.53%) 
Bundle branch block left * 1  1/190 (0.53%) 
Tachycardia * 1  1/190 (0.53%) 
Ventricular extrasystoles * 1  1/190 (0.53%) 
Ear and labyrinth disorders   
Ear discomfort * 1  2/190 (1.05%) 
Deafness neurosensory * 1  1/190 (0.53%) 
Tinnitus * 1  1/190 (0.53%) 
Vertigo * 1  1/190 (0.53%) 
Eye disorders   
Conjunctivitis allergic * 1  4/190 (2.11%) 
Conjunctival haemorrhage * 1  2/190 (1.05%) 
Diabetic retinopathy * 1  2/190 (1.05%) 
Blepharitis * 1  1/190 (0.53%) 
Cataract * 1  1/190 (0.53%) 
Conjunctivitis * 1  1/190 (0.53%) 
Eye haemorrhage * 1  1/190 (0.53%) 
Keratitis * 1  1/190 (0.53%) 
Posterior capsule opacification * 1  1/190 (0.53%) 
Vitreous detachment * 1  1/190 (0.53%) 
Gastrointestinal disorders   
Nausea * 1  101/190 (53.16%) 
Constipation * 1  75/190 (39.47%) 
Vomiting * 1  68/190 (35.79%) 
Stomach discomfort * 1  18/190 (9.47%) 
Diarrhoea * 1  17/190 (8.95%) 
Abdominal pain upper * 1  16/190 (8.42%) 
Gastritis * 1  9/190 (4.74%) 
Stomatitis * 1  9/190 (4.74%) 
Dyspepsia * 1  8/190 (4.21%) 
Dry mouth * 1  6/190 (3.16%) 
Reflux oesophagitis * 1  4/190 (2.11%) 
Abdominal distension * 1  3/190 (1.58%) 
Abdominal pain * 1  3/190 (1.58%) 
Gastric ulcer * 1  3/190 (1.58%) 
Periodontitis * 1  3/190 (1.58%) 
Haemorrhoids * 1  2/190 (1.05%) 
Abdominal discomfort * 1  1/190 (0.53%) 
Anal fistula * 1  1/190 (0.53%) 
Cheilitis * 1  1/190 (0.53%) 
Colonic polyp * 1  1/190 (0.53%) 
Dental caries * 1  1/190 (0.53%) 
Gastrooesophageal reflux disease * 1  1/190 (0.53%) 
Gastrointestinal disorder * 1  1/190 (0.53%) 
Gingivitis * 1  1/190 (0.53%) 
Glossitis * 1  1/190 (0.53%) 
Hiatus hernia * 1  1/190 (0.53%) 
Inguinal hernia * 1  1/190 (0.53%) 
Melanosis coli * 1  1/190 (0.53%) 
Oral discomfort * 1  1/190 (0.53%) 
Gastrointestinal hypermotility * 1  1/190 (0.53%) 
Gastric mucosal lesion * 1  1/190 (0.53%) 
Oral mucosa erosion * 1  1/190 (0.53%) 
Gastrointestinal sounds abnormal * 1  1/190 (0.53%) 
General disorders   
Malaise * 1  15/190 (7.89%) 
Feeling abnormal * 1  13/190 (6.84%) 
Thirst * 1  12/190 (6.32%) 
Pyrexia * 1  8/190 (4.21%) 
Oedema peripheral * 1  7/190 (3.68%) 
Chest discomfort * 1  3/190 (1.58%) 
Oedema * 1  2/190 (1.05%) 
Application site dermatitis * 1  1/190 (0.53%) 
Asthenia * 1  1/190 (0.53%) 
Chills * 1  1/190 (0.53%) 
Feeling cold * 1  1/190 (0.53%) 
Injection site haematoma * 1  1/190 (0.53%) 
Pain * 1  1/190 (0.53%) 
Peripheral coldness * 1  1/190 (0.53%) 
Vessel puncture site haematoma * 1  1/190 (0.53%) 
Hepatobiliary disorders   
Cholelithiasis * 1  2/190 (1.05%) 
Hepatic function abnormal * 1  1/190 (0.53%) 
Liver disorder * 1  1/190 (0.53%) 
Immune system disorders   
Seasonal allergy * 1  3/190 (1.58%) 
Infections and infestations   
Nasopharyngitis * 1  49/190 (25.79%) 
Gastroenteritis * 1  5/190 (2.63%) 
Cystitis * 1  4/190 (2.11%) 
Pharyngitis * 1  4/190 (2.11%) 
Oral herpes * 1  4/190 (2.11%) 
Bronchitis * 1  2/190 (1.05%) 
Rhinitis * 1  2/190 (1.05%) 
Tinea pedis * 1  2/190 (1.05%) 
Bronchiectasis * 1  1/190 (0.53%) 
Furuncle * 1  1/190 (0.53%) 
Gastrointestinal candidiasis * 1  1/190 (0.53%) 
Herpes zoster * 1  1/190 (0.53%) 
Influenza * 1  1/190 (0.53%) 
Onychomycosis * 1  1/190 (0.53%) 
Paronychia * 1  1/190 (0.53%) 
Urinary tract infection * 1  1/190 (0.53%) 
Helicobacter infection * 1  1/190 (0.53%) 
Tinea infection * 1  1/190 (0.53%) 
Oral fungal infection * 1  1/190 (0.53%) 
Purulence * 1  1/190 (0.53%) 
Injury, poisoning and procedural complications   
Fall * 1  11/190 (5.79%) 
Wound * 1  5/190 (2.63%) 
Excoriation * 1  3/190 (1.58%) 
Thermal burn * 1  3/190 (1.58%) 
Joint sprain * 1  2/190 (1.05%) 
Arthropod sting * 1  1/190 (0.53%) 
Back injury * 1  1/190 (0.53%) 
Burns second degree * 1  1/190 (0.53%) 
Foot fracture * 1  1/190 (0.53%) 
Foreign body in eye * 1  1/190 (0.53%) 
Hand fracture * 1  1/190 (0.53%) 
Rib fracture * 1  1/190 (0.53%) 
Spinal compression fracture * 1  1/190 (0.53%) 
Contusion * 1  1/190 (0.53%) 
Procedural pain * 1  1/190 (0.53%) 
Investigations   
Weight decreased * 1  23/190 (12.11%) 
Gamma-glutamyltransferase increased * 1  21/190 (11.05%) 
Blood creatine phosphokinase increased * 1  19/190 (10.00%) 
Blood triglycerides increased * 1  14/190 (7.37%) 
Blood pressure increased * 1  11/190 (5.79%) 
Blood urea increased * 1  10/190 (5.26%) 
Alanine aminotransferase increased * 1  9/190 (4.74%) 
Glucose urine present * 1  7/190 (3.68%) 
Blood urine present * 1  7/190 (3.68%) 
Aspartate aminotransferase increased * 1  6/190 (3.16%) 
Blood alkaline phosphatase increased * 1  6/190 (3.16%) 
Blood potassium increased * 1  5/190 (2.63%) 
Liver function test abnormal * 1  5/190 (2.63%) 
Eosinophil percentage increased * 1  5/190 (2.63%) 
White blood cell count increased * 1  4/190 (2.11%) 
Haemoglobin decreased * 1  3/190 (1.58%) 
Weight increased * 1  3/190 (1.58%) 
Protein urine present * 1  3/190 (1.58%) 
Albumin urine present * 1  2/190 (1.05%) 
Blood creatinine increased * 1  2/190 (1.05%) 
Blood pressure systolic increased * 1  2/190 (1.05%) 
C-reactive protein increased * 1  2/190 (1.05%) 
Red blood cell count decreased * 1  2/190 (1.05%) 
Platelet count increased * 1  2/190 (1.05%) 
Blood cholesterol increased * 1  1/190 (0.53%) 
Blood glucose increased * 1  1/190 (0.53%) 
Blood pressure diastolic decreased * 1  1/190 (0.53%) 
Blood uric acid increased * 1  1/190 (0.53%) 
Monocyte count increased * 1  1/190 (0.53%) 
Platelet count decreased * 1  1/190 (0.53%) 
Neutrophil percentage decreased * 1  1/190 (0.53%) 
Blood lactate dehydrogenase increased * 1  2/190 (1.05%) 
Metabolism and nutrition disorders   
Anorexia * 1  17/190 (8.95%) 
Decreased appetite * 1  9/190 (4.74%) 
Hypoglycaemia * 1  4/190 (2.11%) 
Dehydration * 1  2/190 (1.05%) 
Diabetes mellitus * 1  2/190 (1.05%) 
Hypercholesterolaemia * 1  1/190 (0.53%) 
Hyperglycaemia * 1  1/190 (0.53%) 
Hypertriglyceridaemia * 1  1/190 (0.53%) 
Hyperuricaemia * 1  1/190 (0.53%) 
Hyperlipidaemia * 1  1/190 (0.53%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  7/190 (3.68%) 
Osteoarthritis * 1  6/190 (3.16%) 
Back pain * 1  5/190 (2.63%) 
Muscle spasms * 1  4/190 (2.11%) 
Spinal osteoarthritis * 1  4/190 (2.11%) 
Pain in extremity * 1  3/190 (1.58%) 
Periarthritis * 1  2/190 (1.05%) 
Rheumatoid arthritis * 1  2/190 (1.05%) 
Intervertebral disc protrusion * 1  2/190 (1.05%) 
Arthritis * 1  1/190 (0.53%) 
Fasciitis * 1  1/190 (0.53%) 
Flank pain * 1  1/190 (0.53%) 
Lumbar spinal stenosis * 1  1/190 (0.53%) 
Osteoporosis * 1  1/190 (0.53%) 
Rotator cuff syndrome * 1  1/190 (0.53%) 
Trigger finger * 1  1/190 (0.53%) 
Upper extremity mass * 1  1/190 (0.53%) 
Musculoskeletal discomfort * 1  1/190 (0.53%) 
Spinal ligament ossification * 1  1/190 (0.53%) 
Spondylolisthesis * 1  1/190 (0.53%) 
Nervous system disorders   
Dizziness * 1  52/190 (27.37%) 
Somnolence * 1  38/190 (20.00%) 
Headache * 1  28/190 (14.74%) 
Dysgeusia * 1  4/190 (2.11%) 
Hypoaesthesia * 1  4/190 (2.11%) 
Cervicobrachial syndrome * 1  3/190 (1.58%) 
Carpal tunnel syndrome * 1  2/190 (1.05%) 
Cerebral infarction * 1  1/190 (0.53%) 
Dizziness postural * 1  1/190 (0.53%) 
Dyskinesia * 1  1/190 (0.53%) 
Head discomfort * 1  1/190 (0.53%) 
Hypertonia * 1  1/190 (0.53%) 
Intracranial aneurysm * 1  1/190 (0.53%) 
IVth nerve paralysis * 1  1/190 (0.53%) 
Memory impairment * 1  1/190 (0.53%) 
Paraesthesia * 1  1/190 (0.53%) 
Parosmia * 1  1/190 (0.53%) 
Post herpetic neuralgia * 1  1/190 (0.53%) 
Sciatica * 1  1/190 (0.53%) 
Occipital neuralgia * 1  1/190 (0.53%) 
Psychiatric disorders   
Insomnia * 1  15/190 (7.89%) 
Delusion * 1  1/190 (0.53%) 
Depressed mood * 1  1/190 (0.53%) 
Hallucination, auditory * 1  1/190 (0.53%) 
Hallucination, visual * 1  1/190 (0.53%) 
Listless * 1  1/190 (0.53%) 
Sleep disorder * 1  1/190 (0.53%) 
Depressive symptom * 1  1/190 (0.53%) 
Affect lability * 1  1/190 (0.53%) 
Anxiety disorder * 1  1/190 (0.53%) 
Renal and urinary disorders   
Dysuria * 1  7/190 (3.68%) 
Haematuria * 1  1/190 (0.53%) 
Micturition disorder * 1  1/190 (0.53%) 
Nephrolithiasis * 1  1/190 (0.53%) 
Proteinuria * 1  1/190 (0.53%) 
Urinary retention * 1  1/190 (0.53%) 
Reproductive system and breast disorders   
Benign prostatic hyperplasia * 1  2/190 (1.05%) 
Respiratory, thoracic and mediastinal disorders   
Upper respiratory tract inflammation * 1  5/190 (2.63%) 
Dysphonia * 1  2/190 (1.05%) 
Dyspnoea * 1  2/190 (1.05%) 
Productive cough * 1  2/190 (1.05%) 
Cough * 1  1/190 (0.53%) 
Hyperventilation * 1  1/190 (0.53%) 
Nasal congestion * 1  1/190 (0.53%) 
Rhinitis allergic * 1  1/190 (0.53%) 
Nasal cyst * 1  1/190 (0.53%) 
Sputum retention * 1  1/190 (0.53%) 
Nasal mucosal disorder * 1  1/190 (0.53%) 
Skin and subcutaneous tissue disorders   
Pruritus * 1  12/190 (6.32%) 
Hyperhidrosis * 1  11/190 (5.79%) 
Eczema * 1  9/190 (4.74%) 
Rash * 1  8/190 (4.21%) 
Dermatitis contact * 1  5/190 (2.63%) 
Cold sweat * 1  4/190 (2.11%) 
Urticaria * 1  4/190 (2.11%) 
Dermatitis * 1  2/190 (1.05%) 
Pruritus generalised * 1  2/190 (1.05%) 
Eczema asteatotic * 1  1/190 (0.53%) 
Erythema * 1  1/190 (0.53%) 
Haemorrhage subcutaneous * 1  1/190 (0.53%) 
Hyperkeratosis * 1  1/190 (0.53%) 
Prurigo * 1  1/190 (0.53%) 
Senile pruritus * 1  1/190 (0.53%) 
Skin chapped * 1  1/190 (0.53%) 
Skin erosion * 1  1/190 (0.53%) 
Skin ulcer * 1  1/190 (0.53%) 
Skin swelling * 1  1/190 (0.53%) 
Diabetic bullosis * 1  1/190 (0.53%) 
Skin mass * 1  1/190 (0.53%) 
Vascular disorders   
Hypertension * 1  14/190 (7.37%) 
Hot flush * 1  4/190 (2.11%) 
Blood pressure fluctuation * 1  1/190 (0.53%) 
Hypotension * 1  1/190 (0.53%) 
Arteriosclerosis obliterans * 1  1/190 (0.53%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA/J V11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release.
Results Point of Contact
Name/Title: Medical Director
Organization: Neuroscience Department, Clinical Science Division, R&D, JANSSEN PHARMACEUTICAL. K.K. 5-2, Nishi-kanda 3-chome, Cyiyoda-ku, Tokyo 101-0065 JAPAN
Phone: +81-3-4411-5509
Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT00736957     History of Changes
Other Study ID Numbers: CR015115
JNS013-JPN-05
First Submitted: August 14, 2008
First Posted: August 18, 2008
Results First Submitted: March 25, 2013
Results First Posted: June 20, 2013
Last Update Posted: July 2, 2014