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An Efficacy Study of Combination of Tramadol and Acetaminophen Tablets in the Treatment of Participants With Fibromyalgia Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00766675
Recruitment Status : Completed
First Posted : October 6, 2008
Results First Posted : July 3, 2013
Last Update Posted : July 3, 2013
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Taiwan Ltd

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pain
Fibromyalgia
Interventions Drug: Tramadol hydrochloride
Drug: Acetaminophen
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tramadol Hydrochloride/Acetaminophen
Hide Arm/Group Description Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
Period Title: Overall Study
Started 80
Completed 40
Not Completed 40
Reason Not Completed
Adverse Event             16
Lost to Follow-up             2
Withdrawal by Subject             11
Protocol Violation             8
Participant took prohibited medication             1
Receive other anti-neoplastic treatment             1
Insufficient therapy             1
Arm/Group Title Tramadol Hydrochloride/Acetaminophen
Hide Arm/Group Description Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
Overall Number of Baseline Participants 80
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants
50.4  (10.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
Female
74
  92.5%
Male
6
   7.5%
Pain Visual Analog Scale at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 80 participants
71.3  (18.22)
[1]
Measure Description: Assessed by 100 mm of VAS from 0 to 100, where 0 mm=no pain and 10 mm=worse pain.
1.Primary Outcome
Title Pain Visual Analog Scale Score at Day 14
Hide Description Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)".
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Tramadol Hydrochloride/Acetaminophen
Hide Arm/Group Description:
Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
Overall Number of Participants Analyzed 73
Mean (Standard Deviation)
Unit of Measure: Millimeter (mm)
53.0  (20.12)
2.Primary Outcome
Title Pain Visual Analog Scale Score at Day 28
Hide Description Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)".
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Tramadol Hydrochloride/Acetaminophen
Hide Arm/Group Description:
Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
Overall Number of Participants Analyzed 73
Mean (Standard Deviation)
Unit of Measure: Millimeter (mm)
49.6  (20.95)
3.Primary Outcome
Title Pain Visual Analog Scale Score at Day 56
Hide Description Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)".
Time Frame Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Tramadol Hydrochloride/Acetaminophen
Hide Arm/Group Description:
Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
Overall Number of Participants Analyzed 73
Mean (Standard Deviation)
Unit of Measure: Millimeter (mm)
44.9  (20.95)
4.Secondary Outcome
Title Number of Participants With Categorical Scores on Pain Relief Rating Scale
Hide Description Pain Relief Rating Scale was used to measure the amount of pain relief experienced (on average) relative to the no-medication Screening or wash-out phase using a 6-point Likert scale ranging from (-) 1 to 4 and rated as (-) 1=worse, 0=None, 1=Slight, 2=moderate,3=a lot and 4=complete.
Time Frame Day 14, 28 and 56
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all enrolled participants.
Arm/Group Title Tramadol Hydrochloride/Acetaminophen
Hide Arm/Group Description:
Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: Participants
A lot:Day 14 12
Moderate:Day 14 19
Slight:Day 14 24
None:Day 14 4
Worse:Day 14 2
Missing:Day 14 19
A lot:Day 28 17
Moderate:Day 28 23
Slight:Day 28 14
None:Day 28 5
Worse:Day 28 3
Missing:Day 28 18
A lot:Day 56 25
Moderate:Day 56 13
Slight:Day 56 18
None:Day 56 9
Worse:Day 56 3
Missing:Day 56 12
5.Secondary Outcome
Title Tender-Point Evaluation/ Myalgic Score
Hide Description Eighteen tender-point sites were evaluated by digital palpation for pain by the same Investigator at each site. The Investigator rated the participant's response to digital palpation on a scale from 0 (no pain [participant did not have a tender point]) to 3 (participant withdrawn or flinched). Total myalgic score was the sum of tender-point pain ratings.The total tender-Point score ranges from 0 to 18, and the total myalgic score ranges from 0 to 54. Higher score indicates worsening.
Time Frame Baseline and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Tramadol Hydrochloride/Acetaminophen
Hide Arm/Group Description:
Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Tender-Point Evaluation (right side):Baseline 7.9  (1.2)
Myalgic Score (right side):Baseline 13.6  (4.0)
Tender-Point Evaluation (left side):Baseline 7.8  (1.2)
Myalgic Score (left side):Baseline 13.1  (4.1)
Tender-Point Evaluation (right side):Day 56 4.9  (2.5)
Myalgic Score (right side):Day 56 7.0  (5.3)
Tender-Point Evaluation (left side):Day 56 5.1  (2.4)
Myalgic Score (left side):Day 56 7.2  (5.2)
6.Secondary Outcome
Title Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept
Hide Description The patient assessment sleep questionnaire consisted of 12-Questions (Q) to evaluate the participant’s sleep habits out of which Q1 was “How long did it usually take for participant to fall asleep during the past 4 weeks” and Q2 was “On the average, how many hours did participant sleep each night during the past 4 weeks”.
Time Frame Baseline and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Tramadol Hydrochloride/Acetaminophen
Hide Arm/Group Description:
Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: Hours
Question 1: Baseline 3.2  (1.3)
Question 2: Baseline 5.4  (1.5)
Question 1: Day 56 2.2  (1.2)
Question 2: Day 56 6.4  (1.3)
7.Secondary Outcome
Title Participant Assessment Sleep Questionnaire Score
Hide Description Sleep questionnaire consisted of 12-Questions (Q), Q3-Q12 were related to “How often during past 4 weeks did participant felt” and are as: Q3: sleep not quiet, Q4: get enough sleep to feel rested upon waking in morning, Q5: awaken short of breath or with headache, Q6: feel drowsy or sleepy, Q7: have trouble falling asleep, Q8: awaken during sleep time and have trouble falling asleep again, Q9: trouble staying awake during day, Q10: snore, Q11: take naps during day, Q12: get amount of sleep needed. Score ranged from 1= all the time to 6 = none of the time, higher score indicates improvement.
Time Frame Baseline and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Tramadol Hydrochloride/Acetaminophen
Hide Arm/Group Description:
Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Question 3: Baseline 2.5  (1.3)
Question 4: Baseline 4.5  (1.3)
Question 5: Baseline 3.8  (1.6)
Question 6: Baseline 2.9  (1.5)
Question 7: Baseline 2.9  (1.6)
Question 8: Baseline 2.9  (1.5)
Question 9: Baseline 3.5  (1.6)
Question 10: Baseline 3.4  (1.5)
Question 11: Baseline 3.3  (1.7)
Question 12: Baseline 4.7  (1.3)
Question 3: Day 56 3.8  (1.3)
Question 4: Day 56 3.5  (1.4)
Question 5: Day 56 4.9  (1.1)
Question 6: Day 56 4.3  (1.3)
Question 7: Day 56 4.2  (1.5)
Question 8: Day 56 4.4  (1.3)
Question 9: Day 56 4.4  (1.4)
Question 10: Day 56 4.6  (1.1)
Question 11: Day 56 4.2  (1.4)
Question 12: Day 56 3.8  (1.6)
8.Secondary Outcome
Title Total Fibromyalgia Impact Questionnaire (FIQ) Score
Hide Description The FIQ was 19-item questionnaire which measured participant status, progress and outcomes. First 10 items made up of a physical functioning scale, ranging from 0 (always) to 3 (never). Items 11 and 12 asked participants to mark the number of days they felt well (0-7 days) and missed work (0-5 days). Items 13-19 were measured using 10 centimeter (cm) visual analog scale, score ranging from 0 cm (no) to 10 cm (very). Total FIQ score ranged from 0 -100 which was calculated as sum of final scores for item 1-10, 11 and 12, and individual score for item 13-19, and higher score indicates worsening.
Time Frame Baseline and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure and "n" signifies those participants who were evaluated for this measure at the specified time point.
Arm/Group Title Tramadol Hydrochloride/Acetaminophen
Hide Arm/Group Description:
Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
Overall Number of Participants Analyzed 73
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=73) 6.1  (1.55)
Day 56 (n=51) 4.0  (1.94)
9.Secondary Outcome
Title Number of Participants With Physician Global Assessment
Hide Description The treating physician rated the participant's condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participant's condition was indicated as very good, good, moderate, poor and very poor.
Time Frame Day 14, 28 and 56
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all enrolled participants.
Arm/Group Title Tramadol Hydrochloride/Acetaminophen
Hide Arm/Group Description:
Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: Participants
Q1: Very good (Day 14) 2
Q1: Good (Day 14) 18
Q1: Moderate (Day 14) 30
Q1: Poor (Day 14) 10
Q1: Very poor (Day 14) 2
Q1: Missing (Day 14) 18
Q2: Very good (Day 14) 19
Q2: Good (Day 14) 23
Q2: Moderate (Day 14) 14
Q2: Poor (Day 14) 4
Q2: Very poor (Day 14) 2
Q2: Missing (Day 14) 18
Q3: Very good (Day 14) 3
Q3: Good (Day 14) 14
Q3: Moderate (Day 14) 34
Q3: Poor (Day 14) 10
Q3: Very poor (Day 14) 1
Q3: Missing (Day 14) 18
Q1: Very good (Day 28) 3
Q1: Good (Day 28) 20
Q1: Moderate (Day 28) 19
Q1: Poor (Day 28) 7
Q1: Very poor (Day 28) 0
Q1: Missing (Day 28) 31
Q2: Very good (Day 28) 14
Q2: Good (Day 28) 22
Q2: Moderate (Day 28) 11
Q2: Poor (Day 28) 2
Q2: Very poor (Day 28) 0
Q2: Missing (Day 28) 31
Q3: Very good (Day 28) 3
Q3: Good (Day 28) 23
Q3: Moderate (Day 28) 17
Q3: Poor (Day 28) 6
Q3: Very poor (Day 28) 0
Q3: Missing (Day 28) 31
Q1: Very good (Day 56) 5
Q1: Good (Day 56) 20
Q1: Moderate (Day 56) 18
Q1: Poor (Day 56) 8
Q1: Very poor (Day 56) 1
Q1: Missing (Day 56) 28
Q2: Very good (Day 56) 13
Q2: Good (Day 56) 22
Q2: Moderate (Day 56) 13
Q2: Poor (Day 56) 2
Q2: Very poor (Day 56) 2
Q2: Missing (Day 56) 28
Q3: Very good (Day 56) 4
Q3: Good (Day 56) 26
Q3: Moderate (Day 56) 15
Q3: Poor (Day 56) 6
Q3: Very poor (Day 56) 1
Q3: Missing (Day 56) 28
10.Secondary Outcome
Title Number of Participants With Subject's Global Assessment
Hide Description Participants indicated their condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participants indicated their condition as very good, good, moderate, poor and very poor.
Time Frame Day 14, 28 and 56
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all enrolled participants.
Arm/Group Title Tramadol Hydrochloride/Acetaminophen
Hide Arm/Group Description:
Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: Participants
Q1: Very good (Day 14) 5
Q1: Good (Day 14) 8
Q1: Moderate (Day 14) 32
Q1: Poor (Day 14) 15
Q1: Very poor (Day 14) 2
Q1: Missing (Day 14) 18
Q2: Very good (Day 14) 16
Q2: Good (Day 14) 21
Q2: Moderate (Day 14) 19
Q2: Poor (Day 14) 3
Q2: Very poor (Day 14) 3
Q2: Missing (Day 14) 18
Q3: Very good (Day 14) 3
Q3: Good (Day 14) 8
Q3: Moderate (Day 14) 38
Q3: Poor (Day 14) 13
Q3: Very poor (Day 14) 0
Q3: Missing (Day 14) 18
Q1: Very good (Day 28) 3
Q1: Good (Day 28) 15
Q1: Moderate (Day 28) 21
Q1: Poor (Day 28) 7
Q1: Very poor (Day 28) 3
Q1: Missing (Day 28) 31
Q2: Very good (Day 28) 16
Q2: Good (Day 28) 16
Q2: Moderate (Day 28) 13
Q2: Poor (Day 28) 4
Q2: Very poor (Day 28) 0
Q2: Missing (Day 28) 31
Q3: Very good (Day 28) 3
Q3: Good (Day 28) 17
Q3: Moderate (Day 28) 21
Q3: Poor (Day 28) 8
Q3: Very poor (Day 28) 0
Q3: Missing (Day 28) 31
Q1: Very good (Day 56) 4
Q1: Good (Day 56) 18
Q1: Moderate (Day 56) 19
Q1: Poor (Day 56) 10
Q1: Very poor (Day 56) 1
Q1: Missing (Day 56) 28
Q2: Very good (Day 56) 14
Q2: Good (Day 56) 21
Q2: Moderate (Day 56) 9
Q2: Poor (Day 56) 4
Q2: Very poor (Day 56) 4
Q2: Missing (Day 56) 28
Q3: Very good (Day 56) 4
Q3: Good (Day 56) 16
Q3: Moderate (Day 56) 25
Q3: Poor (Day 56) 7
Q3: Very poor (Day 56) 0
Q3: Missing (Day 56) 28
Time Frame Baseline up to Day 56
Adverse Event Reporting Description An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
 
Arm/Group Title Tramadol Hydrochloride/Acetaminophen
Hide Arm/Group Description Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
All-Cause Mortality
Tramadol Hydrochloride/Acetaminophen
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tramadol Hydrochloride/Acetaminophen
Affected / at Risk (%)
Total   2/80 (2.50%) 
Injury, poisoning and procedural complications   
Forearm fracture * 1  1/80 (1.25%) 
Road traffic accident * 1  1/80 (1.25%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tramadol Hydrochloride/Acetaminophen
Affected / at Risk (%)
Total   49/80 (61.25%) 
Cardiac disorders   
Palpitations * 1  2/80 (2.50%) 
Gastrointestinal disorders   
Abdominal pain * 1  1/80 (1.25%) 
Abdominal pain upper * 1  2/80 (2.50%) 
Constipation * 1  4/80 (5.00%) 
Dry mouth * 1  12/80 (15.00%) 
Flatulence * 1  2/80 (2.50%) 
Gastritis * 1  1/80 (1.25%) 
Nausea * 1  9/80 (11.25%) 
Vomiting * 1  5/80 (6.25%) 
Diarrhoea * 1  2/80 (2.50%) 
General disorders   
Asthenia * 1  3/80 (3.75%) 
Chest pain * 1  2/80 (2.50%) 
Malaise * 1  1/80 (1.25%) 
Pain * 1  1/80 (1.25%) 
Immune system disorders   
Dermatomyositis * 1  2/80 (2.50%) 
Drug eruption * 1  3/80 (3.75%) 
Infections and infestations   
Nasopharyngitis * 1  1/80 (1.25%) 
Metabolism and nutrition disorders   
Gout * 1  1/80 (1.25%) 
Musculoskeletal and connective tissue disorders   
Muscle tightness * 1  1/80 (1.25%) 
Musculoskeletal pain * 1  1/80 (1.25%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasm skin * 1  1/80 (1.25%) 
Nervous system disorders   
Dizziness * 1  14/80 (17.50%) 
Headache * 1  1/80 (1.25%) 
Vertigo * 1  4/80 (5.00%) 
Psychiatric disorders   
Akathisia * 1  1/80 (1.25%) 
Anorexia * 1  2/80 (2.50%) 
Anxiety * 1  1/80 (1.25%) 
Decreased appetite * 1  2/80 (2.50%) 
Sleep disorder * 1  1/80 (1.25%) 
Somnolence * 1  5/80 (6.25%) 
Renal and urinary disorders   
Dysuria * 1  1/80 (1.25%) 
Respiratory, thoracic and mediastinal disorders   
Adenoviral upper respiratory * 1  3/80 (3.75%) 
Skin and subcutaneous tissue disorders   
Cellulitis * 1  1/80 (1.25%) 
Dermatitis allergic * 1  1/80 (1.25%) 
Hyperhidrosis * 1  1/80 (1.25%) 
Pruritus * 1  4/80 (5.00%) 
Rash * 1  1/80 (1.25%) 
Vascular disorders   
Ecchymosis * 1  1/80 (1.25%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 12.0
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.
Results Point of Contact
Name/Title: Medical Affairs Director
Organization: Janssen Pharmaceutics Taiwan
Phone: +886-2-23762155
Responsible Party: Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier: NCT00766675     History of Changes
Other Study ID Numbers: CR015319
TRAMMAPPAI4033
First Submitted: October 3, 2008
First Posted: October 6, 2008
Results First Submitted: February 18, 2013
Results First Posted: July 3, 2013
Last Update Posted: July 3, 2013