Clinical trial NCT00766675: An Efficacy Study of Combination of Tramadol and Acetaminophen Tablets in the Treatment of Participants With Fibromyalgia Pain
Official title: Ultracet (Tramadol HCL [37.5 mg]/Acetaminophen [325 mg]) Combination Tablets in the Treatment of the Pain of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Fibromyalgia
Keywords: Pain
Fibromyalgia
Ultracet
Tramadol Hydrochloride
Acetaminophen
Lead sponsor: Johnson & Johnson Taiwan Ltd
Sponsor class: INDUSTRY
First posted: 2008-10-06
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the analgesic effect of combination of tramadol hydrochloride and acetaminophen in participants for treatment of fibromyalgia pain (chronic widespread pain and presence of tender points).

Detailed description: This is an open-label (all people know the identity of the intervention) and multi-center (conducted in more than one center) study of combination of tramadol hydrochloride and acetaminophen in treatment of participants with pain of fibromyalgia. The duration of this study will be 56 days per participant. The study consists of 2 parts: Screening (that is, 3 weeks before study commences on Day 1) and Treatment (that is, up to Day 56). All the eligible participants will receive oral tablet for combination of tramadol hydrochloride and acetaminophen. Rescue medication (a medication intended to relieve symptoms immediately) of tylenol (500 milligram, up to 6 oral tablets daily) will be permitted throughout the study duration. Efficacy of the participants will primarily be evaluated by Pain Visual Analog Scale. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Participants must meet the American College of Rheumatology 1990 criteria for the classification of fibromyalgia (that are, Participants must have had widespread pain \[pain in three quadrants and in the axial skeleton\] for at least three months and pain on digital palpation in 11 or more of the 18 tender-point sites
* Female participants must not be pregnant, breast feeding or postmenopausal for at least one year
* Participant must be able to take oral medication
* Participants must have completed the Screening or wash-out procedures and have a visual analog scale score greater than or equal to 40 milliliter
* Fail to non-opioid analgesics

Exclusion Criteria:

* Participants who previously failed tramadol hydrochloride therapy or those who discontinued tramadol hydrochloride due to adverse events
* Participants diagnosed with either any active connective tissue or musculo-skeletal diseases, or malignancy or history of malignancy within past 5 years, or painful, symptomatic osteoarthritis, or regional periarticular pain syndromes, spondyloarthropathy and major endocrine disease
* Participants who currently have more severe pain than the pain of fibromyalgia
* Participants who have taken antidepressants, cyclobenzaprine or anti-epileptic drugs for pain within three weeks of the Treatment Phase
* Participants who have taken short-acting analgesics, topical medications and anesthetics and/or muscle relaxants for a period of less than 21 days of the given medication prior to the Treatment Phase

Primary outcomes:
measure: Pain Visual Analog Scale Score at Day 14
timeFrame: Day 14
measure: Pain Visual Analog Scale Score at Day 28
timeFrame: Day 28
measure: Pain Visual Analog Scale Score at Day 56
timeFrame: Day 56
Secondary outcomes:
measure: Number of Participants With Categorical Scores on Pain Relief Rating Scale
timeFrame: Day 14, 28 and 56
measure: Tender-Point Evaluation/ Myalgic Score
timeFrame: Baseline and Day 56
measure: Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept
timeFrame: Baseline and Day 56
measure: Participant Assessment Sleep Questionnaire Score
timeFrame: Baseline and Day 56
measure: Total Fibromyalgia Impact Questionnaire (FIQ) Score
timeFrame: Baseline and Day 56
measure: Number of Participants With Physician Global Assessment
timeFrame: Day 14, 28 and 56
measure: Number of Participants With Subject's Global Assessment
timeFrame: Day 14, 28 and 56
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Taiwan Ltd
name: Johnson & Johnson Taiwan Ltd Clinical Trial
role: STUDY_DIRECTOR
References: