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

NCT00766675 | Completed Phase 4 Results

• 2 other identifiers: CR015319TRAMMAPPAI4033
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Pain; Fibromyalgia

Keywords

Pain; Fibromyalgia; Ultracet; Tramadol Hydrochloride; Acetaminophen

Outcome Measures

Primary Outcomes (3)

• Pain Visual Analog Scale Score at Day 14

  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)".

  Day 14

• Pain Visual Analog Scale Score at Day 28

  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)".

  Day 28

• Pain Visual Analog Scale Score at Day 56

  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)".

  Day 56

Secondary Outcomes (7)

• Number of Participants With Categorical Scores on Pain Relief Rating Scale

  Day 14, 28 and 56

• Tender-Point Evaluation/ Myalgic Score

  Baseline and Day 56

• Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept

  Baseline and Day 56

• Participant Assessment Sleep Questionnaire Score

  Baseline and Day 56

• Total Fibromyalgia Impact Questionnaire (FIQ) Score

  Baseline and Day 56

Study Arms (1)

Tramadol hydrochloride/acetaminophen

EXPERIMENTAL

Tramadol hydrochloride/acetaminophen oral tablet will be 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.

Drug: Tramadol hydrochloride; Drug: Acetaminophen

Interventions

Tramadol hydrochloride DRUG

Tramadol hydrochloride oral tablet will be administered at a dose of 37.5 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.

Tramadol hydrochloride/acetaminophen

Acetaminophen DRUG

Acetaminophen oral tablet will be administered at a dose of 325 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.

Tramadol hydrochloride/acetaminophen

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Taiwan Ltd: lead

MeSH Terms

Conditions

Pain; Fibromyalgia

Interventions

Tramadol; Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Acetanilides; Anilides; Amides; Aniline Compounds

Results Point of Contact

• Title: Medical Affairs Director
• Organization: Janssen Pharmaceutics Taiwan

+886-2-23762155

Study Officials

• Johnson & Johnson Taiwan Ltd Clinical Trial

  Johnson & Johnson Taiwan Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 6, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: July 3, 2013
• Results First Posted: July 3, 2013

Record last verified: 2013-05