A phase II, multicentre, multinational, prospective, randomised, double-blind, placebo controlled study assessing the efficacy and safety of a single application of three doses of Dysport in patients with upper back myofascial pain syndrome (MPS)

Beaufour Ipsen Pharma S.A.S.0 个研究点目标入组 340 人开始时间: 2005年2月15日最近更新: 2012年3月19日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 340

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•The patient must present at baseline with pain score of moderate or severe on a 4-point rating scale. Pain score is an overall rating of pain experienced during activity over the 7 days prior to the visit.
•The patient must have suffered from upper back, myofascial pain syndrome for more than 6 months.
•The patient must present with at least 3 active TrPs in the region of the upper back musculature (excluding upper neck musculature). An active TrP is defined as a tender spot localised in a taut band of muscle fibres associated with tenderness and referred pain recognised by the patient into well-defined areas that are remote from the TrP area at palpation and, preferably local twitch response at palpation and/or jump sign at palpation (derived from Travell and Simons).
•The patients’ pain medication regimen must be stable and within the normal recommended doses on study entry and must remain so until Week 6.
•The patient must be aged 18 years or older.
•The patient must give written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of the normal medical care of the patient.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

排除标准

•The patient suffers from pericranial or upper neck pain, or specific shoulder pain, such as tumours, radicular syndromes, inflammatory processes, age-untypical degenerative changes, infection, clinically manifest prolapse, neurological failure, chronic polyarthritis, collagenosis, Bechterew's disease, disc herniation, nerve root impingement or fibromyalgia.
•The patient has suffered from upper back MPS for more than 24 months.
•The patient has received surgery on the cervical spine in the last 6 months.
•The patient has any mental condition which results in him/her being unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
•The patient has received anaesthetic injections to the TrP’s within 1 month prior to study entry.
•The patient has received steroid injections for their MPS in the last 3 months.
•The patient has a known history of non-responsiveness to botulinum toxin A or has received botulinum toxin A in the last 6 months.
•The patient has a known history of hypersensitivity to the investigational drug, its constituents or drugs with a similar mechanism of action.
•The patient is likely to require treatment during the study with drugs that are not permitted by the study protocol.
•The patient has hypertension that is not adequately controlled by treatment.
•The patient has a history of other muscular diseases or diseases of neuromuscular transmission e.g. myasthenia gravis.
•The patient has a history of, or current problems with alcohol/drug abuse and/or analgesic overuse/abuse.
•The patient is pregnant or lactating. Females of childbearing potential must provide a negative pregnancy test within 7 days prior to the start of the study and must be using oral or injectable contraception. (Non-childbearing potential is defined as post menopausal for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study).
•The patient has received any other investigational drug within the 30 days prior to study entry.
•The patient has abnormal baseline findings considered by the investigator to indicate conditions that might affect the study.
•The patient has any other condition that, in the opinion of the investigator, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.

研究者

发起方

Beaufour Ipsen Pharma S.A.S.

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