Analgesia & Pain

Specialist Experience


Worldwide has extensive capabilities in global analgesia research, including experience with human experimental and clinical models for proof-of-concept in nociceptive and neuropathic pain and for registration studies to support marketing authorization in a number of acute and chronic pain indications.

Since 2008, we have been involved in the design, execution and analysis of over 20 pain syndrome trials, each of which included at least clinical monitoring or project management services provided by Worldwide. Our team has experience investigating a range of diverse pharmacological classes such as non-steroidal antiinflammatory drugs (NSAIDS), cyclooxygenase (COX)-2 inhibitors, opioids, conopeptides, gabapentinoids, selective or nonselective monoamine reuptake inhibitors (MAOIs), antiepileptic drugs, mitogen activated protein kinase inhibitors, and importantly, non-addictive pain compounds with novel modes of action. Routes of administration have included topical, oral, subcutaneous, intrathecal/ epidural, and intravenous as well as the use of medical devices with different pain indications. From spearheading key opinion leader meetings, advising and consulting in design of analgesic trials and writing the protocols, to report writing and regulatory support, Worldwide has helped to design studies in a variety of pain indications including:

  • Human experimental and clinical pain – third molar, chronic pain, bunionectomy, intradermal capsaicin, ultraviolet-B
  • Acute postoperative pain – ACL repair, hip & knee replacement, orthopedic, post episiotomy pain
  • Chronic pain – chronic low back pain, osteoarthritis, mixed chronic pain, migraine, postherpetic neuralgia, diabetic peripheral neuropathy, distal symmetrical sensorimotor polyneuropathy, small fiber neuropathy, nonspecific low-back pain, mixed neuropathy with chronic, chemo-induced peripheral neuropathy; and complex regional pain syndrome
  • Cancer related pain – ongoing and breakthrough pain

In addition to the above, we have also conducted many studies in which pain was a secondary measure, such as in oncology and rheumatoid arthritis.

Related Articles:

A Review of FDA’s Action Plan to Proactively Reduce Prescription Opioid Abuse
The increasing rates of opioid abuse and dependence, and the alarming rise in the
number of prescription opioid-related overdoses and deaths in the US has caused
government agencies around the globe to launch various initiatives in an attempt
to stem the tide of this devastating public health crisis.
This article is a reference from the Journal for Clinical Studies.

Burn Trauma: An Emerging Model for Acute Pain
Emphasis in acute pain studies has shifted to outcomes that go beyond “good
pain relief” to reductions in the risk of developing chronic pain, acute medical
conditions, and the development of psychological disturbances due to pain.
This article is a reference from the Journal for Clinical Studies.

Related articles can be found on our website:

www.worldwide.com/resources/resource-library/

Trial Design


Worldwide offers state-of-the art trial design capabilities to maximize valuable patient data and reduce developmental timelines for trials in analgesia. Over recent years, the team has been involved the creation of several different study designs in analgesia including cross-over designs with floating baseline, enriched enrollment, and adaptive designs. The team is proficient in established clinical measures designed to assess analgesia, including verbal and numeric rating scales, visual analog scales, and scales that assess qualities of pain and pain interference. In addition to experience with traditional pain measures, Worldwide has also created novel and composite pain scales that have been used in registration trials. Additionally, we have experience across numerous indication specific scales such as the WOMAC, CIPN20, Pain DETECT and OARSI/OMERACT responder criteria as well as measures of incident pain.

Unrivalled Service


Creating a drug development program for the treatment of a pain is a complex task with a number of unique challenges. Our team of scientific, medical, operational, and regulatory staff, have undisputed experience in the clinical practice of pain management as well as extensive knowledge of the operational challenges of advanced pain and analgesia clinical research studies. This, coupled with a true commitment to the success of each and every clinical trial, means Worldwide is ideally placed to be your pain and analgesia clinical research partner. The success of our work in this area is demonstrated by the publication of a number of highimpact scientific papers in which our professionals discuss the subject including innovative trial designs that may improve signal detection for novel therapeutics in chronic pain, as well as ways to minimize placebo response.

  • Cancer Pain
  • Post-operative Pain
  • Dental Pain
  • Low back Pain
  • Migraine
  • Musculoskeletal Pain
  • Pain Management
  • Osteoarthritis Pain
  • Neuropathic Pain
  • Gynecological Pain