Study to evaluate the safety and effects of Voltaren Schmerzgel 1.16% on people with acute neck pain.

• Conditions: Acute neck pain, present for at least 12 hours.An acute condition is defined as pain shorter than 3 months [CPMP, 2002].Neck pain is defined as stiffness and/or pain felt dorsally in the cervical region somewhere between the occipital condyles and the C7 vertebral prominence [Ferrari 2003]. Only subjects with pain generated in the neck originating from cervical joints and accompanying soft tissue will be included.; MedDRA version: 13.1Level: PTClassification code 10028836Term: Neck painSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2010-022794-34-DE
• Lead Sponsor: ovartis Consumer Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Male or female subjects, age range 18 and over.
2.Acute neck pain, present for at least 12 hours.
An acute condition is defined as pain shorter than 3 months [CPMP, 2002].
Neck pain is defined as stiffness and/or pain felt dorsally in the cervical region somewhere between the occipital condyles and the C7 vertebral prominence [Ferrari 2003]. Only subjects with pain generated in the neck originating from cervical joints and accompanying soft tissue will be included.
3.Pain-on-movement (POM) = 50 mm on a 100 mm VAS.
4.Satisfactory health as determined by the investigator based on medical history and physical examination.
5.Subjects must understand and provide written informed consent before any assessment is performed, understand the study procedures, and be willing to complete the required assessments.

Are the trial subjects under 18? no
Number of subjects for this age range: 72
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Current asthma, hay fever, swelling of the nasal mucosa or chronic obstructive respiratory tract diseases.
2. History of or known hypersensitivity to any of the study drugs, excipients or to drugs of similar chemical classes. History of allergy (cutaneous or systemic), hypersensitivity, or asthma to any of the following: diclofenac, paracetamol, acetylsalicylic acid, salicylic acid, other NSAID or cyclooxygenase 2-specific inhibitor (COXIB) or known hypersensitivity (cutaneous or systemic) to any of the ingredients in the gel, such as propylene glycol and/or 2-propanol
3. Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as:
·Surgical sterilization
·Hormonal contraception
·IUD
·Double barrier method
·Total abstinence throughout the study at the discretion of the Investigator.
Periodic abstinence is NOT an acceptable method of contraception. An acceptable method of contraception must be maintained throughout the study.
A woman who is post-menopausal must have a negative urine pregnancy test at screening but will not need to comply with an acceptable method of contraception. Women are considered post-menopausal and not of child bearing potential if they had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago.
4.Pregnant or nursing (lactating) women.
5.Pain medication taken within the 6 hours that precede randomization. Chronic intake of small doses of acetylsalicylic acid (= 162 mg/daily) taken for at least 30 days prior to the first dose of study medication for non-analgesic reasons may be continued for the duration of the study.
6.Concomitant use of any anti-inflammatory drugs, heparinoids or analgesics including herbal preparations (glucocorticosteroids, NSAIDs, etc.) for the same indication or other indications (e.g. rheumatoid arthritis).
7.Any other concomitant treatment (e.g. cosmetics, ointments at the treated area) or medication that interferes with the conduct of the trial.
8.History of active or suspected oesophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days preceding screening.
9.History of clinically significant cardiovascular, cerebrovascular, metabolic, pulmonary, neurological, haematological, autoimmune, psychiatric or endocrine disorders, including individuals with Type I or Type II diabetes.
10.History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
11.Chronic or acute renal or hepatic disorder, inflammatory bowel disease (e.g. Crohn´s disease or ulcerative colitis), or a significant coagulation defect.
12.Subject affected by rheumatoid arthritis or gout.
13.History of uncontrolled chronic or acute concomitant disease which, in the Investigator’s opinion, would contraindicate study participation or confound interpretation of the results.
14.Any neck pain that is attributable to an organic disease, such as prolapsed disc, spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic, neurological diseases or tumors.
15.Any recent strains of the neck muscles documented by the clinical evaluation and anamnes

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To show superior efficacy of Voltaren® Schmerzgel 1.16% gel versus placebo in the treatment of acute neck pain under 'in-use' conditions, as measured by POM at Visit 4.;Secondary Objective: To assess the efficacy of Voltaren® Schmerzgel 1.16% gel at each Visit time.<br>To assess the safety of Voltaren® Schmerzgel 1.16% gel for 5 (+1) days under 'in-use' conditions.<br>;Primary end point(s): The primary efficacy outcome is pain-on-movement measured on the VAS at Visit 4.