This Open-Label Study Will Evaluate the Analgesic Effectiveness and Safety Measurement of Tramadol HCl/Acetaminophen in the Treatment of Pain for Fibromyalgia.

Condition(s) targeted: Pain; Fibromyalgia

Intervention: Ultracet (tramadol HCL/acetaminophen) (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Johnson & Johnson Taiwan Ltd

Official(s) and/or principal investigator(s):
Johnson & Johnson Taiwan, Ltd. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Taiwan Ltd

Overall contact:
This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: info1@veritasmedicine.com

The purpose of the study is to evaluate the analgesic effectiveness and safety measurement of Ultracet in the treatment of pain for fibromyalgia. This is a multicenter, single arm study. Patients receiving antidepressants, cyclobenzaprine or anti-epileptic drugs for pain prior to entering this study, must discontinue these medications at least three weeks before entering the Treatment Phase.

Official title: Ultracet in the Treatment of the Pain of Fibromyalgia

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Difference of the Pain Visual Analog Scale (VAS) at day 1, 14, 28 and 56.

Secondary outcome: The number of discontinuations due to lack of efficacy after the sixth day of the Treatment Phase; Pain Assessments (pain relief scores and tender-point evaluation/myalgic scores); and safety at Day 1, 14, 28 and 56.

Detailed description: Approximately 300 patients meeting the American College of Rheumatology 1990 Criteria for the Classification of fibromyalgia and who meet the inclusion criteria will be enrolled into the study. Accordingly, we generated these relevant hypotheses to use combine medication tramadol HCl (37. 5 mg)/acetaminophen (325 mg) (Ultracet) of Fibromyalgia patients in Asia country-Taiwan. This study has been designed to investigate the following hypothesis: Ultracet is effectiveness in the treatment of the pain of fibromyalgia. The objective of this study is to evaluate the analgesic effectiveness by VAS score and the safety measurement of Ultracet (tramadol HCl (37. 5 mg)/acetaminophen (325 mg)) combination tablets in the treatment of the pain of fibromyalgia. Primary Objective is to compare the Pain Visual Analog Scale (VAS) from the beginning to the end of the study. Secondary Objectives are to see the number of discontinuations due to lack of efficacy, the number of patients who discontinue due to lack of efficacy after the sixth day of the Treatment Phase, pain assessments (pain relief scores and tender-point evaluation/myalgic scores), Sleep Questionnaire, Fibromyalgia Impact Questionnaire (FIQ), Global Assessment of Physician and Subject (PGA & SGA) and Identify the safety profile of Ultracet. This is a multicenter, single arm study, composed of two phases which are Screening/Wash-Out and Treatment. The Screening/Wash-Out Phase will last up to three weeks. Patients with fibromyalgia who meet entrance criteria for the study will be identified. The study will be explained and informed consent will be obtained. Patients receiving antidepressants, cyclobenzaprine or anti-epileptic drugs for pain prior to entering this study, must discontinue these medications at least three weeks before entering the Treatment Phase. Patients must be off all short-acting analgesics (using NSAIDs or steroids as combination therapy on a stable dose is permitted during the study), topical medications and anesthetics and/or muscle relaxants for a period of at least 21 days of the given medication before entering the treatment Phase. Patients receiving chronic therapy with a low dose of a selective serotonin reuptake inhibitor (SSRI) for depression are permitted to enter the Treatment Phase provided they have already been on a stable dose for at least one month prior to the Treatment Phase. Rescue medications are allowed to be prescribed by the treating physician deems the necessity during the Screening/Wash-Out Phase. Patients who have discontinued all pain medication during the Screening/Wash-Out Phase and have at least moderate pain (VAS > =40mm on a 100 mm pain visual analog scale) within the last 48 hours at the end of the Screening/Wash-Out Phase may enter the Treatment Phase following review of baseline evaluations including laboratory results. If at any time during the Wash-Out Phase the patient experiences intolerable pain (VAS >=40mm), he/she may immediately enter the Treatment Phase. The Treatment Phase is approximately 56 days. Patients will be treated with Ultracet (tramadol HCl/acetaminophen). At the time of the scheduled clinic visits (except Visits 1 and 2) or at the time of discontinuation for any reason, patients will be required to complete the Pain Relief Rating Scale indicating the amount of pain relief experienced (on average) relative to the no-medication Screening/Wash-Out Phase and a VAS (except Visit 1) indicating the amount of pain experienced (on average) within the last 48 hours. Patients will also complete the Fibromyalgia Global assessments Health Survey, Sleep Questionnaire, Global Assessments and have a tender point evaluation/myalgic score at the end of the Screening/Wash-Out Phase and at the end of the Treatment Phase or at the time of study discontinuation. Adverse events after the inform consent signing will be recorded on the Adverse Event page of the Case Report Form. Thereafter, patients may increase their daily dosage of study medication as needed up to a maximum of 1 tablet three time a day by oral, not to exceed 3 tablets (112. 5 mg tramadol HCl / 975 mg acetaminophen) per 24-hour period. The titration schedule may be altered at the discretion of the investigator. However, by Day 7 and throughout the remainder of the study the patients must be receiving at least three tablets/day of study medication. Rescue medication consisting of Extra Strength Tylenol (500 mg) 6 tablets daily during the Treatment Phase will be allowed, provided the patient is taking no more than three tablets of study medication daily so that the total daily dose of acetaminophen will not exceed 4,000 mg. Patients should not receive any acetaminophen-containing products other than study medication or Extra-Strength Tylenol rescue medication.

Patients will be treated with Ultracet (tramadol HCl/acetaminophen). Day1 to Day 3 with 1 tablet at bedtime orally. Day 4 to Day 6 with 1 tablet twice a day. Day 7 to Day 56 with1 tablet three times daily.

Minimum age: 20 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients must meet the American College of Rheumatology 1990 Criteria for the

Classification of Fibromyalgia

- Patients must have had widespread pain (pain in three quadrants and in the axial

skeleton) for at least three months

- Patients must have pain on digital palpation in 11 or more of the 18 tender-point

sites

Exclusion Criteria:

- Patients who previously failed tramadol HCl therapy or those who discontinued tramadol

HCl due to adverse events

- Patients who have any of the following: active connective tissue or musculo-skeletal

diseases (e. g., SLE or RA). Non-active SLE or RA patients will be permitted to enter the study. painful, symptomatic osteoarthritis which requires treatment with pain medication. Regional periarticular pain syndromes, spondyloarthropathy and major endocrine disease

- Patients who currently have more severe pain than the pain of fibromyalgia

- Patients who have taken antidepressants, cyclobenzaprine or anti-epileptic drugs for

pain within three weeks of the Treatment Phase

- Patients 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

- Patients who have started to use nutriceuticals (e. g. glucosamine) within four weeks

prior to the Treatment Phase

- Patients who have received tender-point injections of local anesthetics within the

last two months

- Patients with a significant major psychiatric disorder (e. g. major depression) or

subjects receiving anti-psychotic medication

- Patients with a history of estimated creatinine clearance of < 30 mL/min

- Patients receiving acupuncture within three weeks prior to the Treatment Phase

- Patients who have epilepsy

This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: info1@veritasmedicine.com

Last updated: January 29, 2009