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

Trial end date:
Target enrollment:
Participant gender:
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).
Phase 4
Accepts Healthy Volunteers?
Lead Sponsor:
Johnson & Johnson Taiwan Ltd
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