CLINICAL TRIAL

SAF312 for Chronic Pain

Recruiting · 18+ · All Sexes · Memphis, TN

This study is evaluating whether a drug may help people with chronic inflammation of the cornea.

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About the trial for Chronic Pain

Eligible Conditions
Chronic Pain · Chronic Ocular Pain

Treatment Groups

This trial involves 3 different treatments. SAF312 is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
SAF312
DRUG
Experimental Group 2
SAF312
DRUG
Control Group 3
SAF312 Placebo
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAF312
2016
Completed Phase 2
~40

Side Effect Profile for SAF312

SAF312
Show all side effects
Nasopharyngitis
5%
Sinus congestion
3%
Punctate keratitis
3%
Vitreous detachment
3%
Arthralgia
3%
Corneal opacity
3%
Oropharyngeal pain
3%
Pyrexia
3%
Sinusitis
3%
Headache
3%
Vomiting
3%
Tinnitus
0%
Corneal infiltrates
0%
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02961062) in the SAF312 ARM group. Side effects include: Nasopharyngitis with 5%, Sinus congestion with 3%, Punctate keratitis with 3%, Vitreous detachment with 3%, Arthralgia with 3%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People who have had refractive surgery or cataract surgery in both eyes, and are still experiencing pain, are asked to participate in this study. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline, Day 7 and Day 14
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, Day 7 and Day 14.
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether SAF312 will improve 1 primary outcome and 9 secondary outcomes in patients with Chronic Pain. Measurement will happen over the course of Baseline, Week 12.

Change in Ocular Pain Assessment Scale (OPAS) sub-scale Quality of Life
BASELINE, WEEK 12
To evaluate additional efficacy of 2 concentrations of SAF312 vs placebo (e.g., time to improvement in quality of life). Each question in the Ocular Pain Assessment Survey (OPAS) quality of life subscale is scored by the subject on a line marked from 0 (not at all) to 10 (completely) that describes how much pain has interfered with or affected a particular activity (max score= 10/question). A higher score suggests a higher impact by pain on a particular activity.
Change in pain frequency Visual Analog Scale
BASELINE, WEEK 12
To evaluate additional efficacy of 2 concentrations of SAF312 vs placebo (eg., time to pain frequency improvement). The pain frequency Visual Analogue Scale (VAS) is completed by the subject using an electronic diary. A vertical mark is placed on the horizontal scoring line (anchored with 'Rarely' on the left and 'All the Time' on the right) to score the frequency of ocular pain over the past 24 hours (max score=100). Higher scores indicate higher pain frequency.
Change in ocular surface parameters as assessed by lissamine staining
BASELINE, WEEK 12
To evaluate if SAF312 has negative effects to the ocular surface after prolonged TRPV1 inhibition. The degree of lissamine conjunctival staining in two regions (temporal and nasal) is graded on a scale from 0 to 4 (max score = 8/eye). Higher scores suggest higher degrees of corneal staining (worsening).
Change in ocular surface parameters as assessed by the corneal fluorescein staining
BASELINE, WEEK 12
To evaluate if SAF312 has negative effects to the ocular surface after prolonged TRPV1 inhibition. The degree of corneal fluorescein staining in each of five regions (superior, inferior, nasal, temporal, and central) is graded on a scale from 0 to 4 (max score=20/eye). Higher scores suggest higher degrees of corneal staining (worsening).
Change in ocular surface parameters as evaluated by the investigator using the McMonnies redness photographic scale.
BASELINE, WEEK 12
To evaluate if SAF312 has negative effects to the ocular surface after prolonged TRPV1 inhibition. Conjunctival redness in each of two regions (nasal and temporal) is graded on a scale from 0 to 5 using the McMonnies conjunctival redness photographic scale (max score=5/region). Higher scores suggest higher degrees of redness (worsening).
Change in ocular surface parameters as assessed by Schirmer's testing
BASELINE, WEEK 12
To evaluate if SAF312 has negative effects to the ocular surface after prolonged TRPV1 inhibition. The Schirmer's test will be performed without anesthetic. Tear secretion is measured in millimeters based on the length of strip wetted by tears (max score =35 mm/eye). Lower values indicate lower relative amounts of tear secretion (worsening).
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes chronic pain?

The aetiology of [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) can be divided into a number of factors, including pain perception, a biopsychosocial model and the contribution of environmental factors. The identification of such factors and effective application of scientific understanding offers promise for future treatment of chronic pain.

Anonymous Patient Answer

What are the signs of chronic pain?

This paper examines the main chronic pain syndromes and defines and discusses the various sensory and motor phenomena associated with chronic pain. Copyright © 2015 The Authors. Chronic Pain 2(4): e364-e378.

Anonymous Patient Answer

Can chronic pain be cured?

The long-term prognosis is very poor in patients with chronic low back pain treated in general practice. The overall outcome in patients treated with NSAIDs for chronic low back pain is better after three or more months of treatment than after a shorter one. The long-term prognosis of these patients is worse than in the general population, but also poorer than in those with high-quality care.

Anonymous Patient Answer

How many people get chronic pain a year in the United States?

In the United States, almost 15 million people have a disabling chronic pain problem on any given day. Chronic pain can have significant impacts on an individual's daily life. Understanding the burden on individuals with disabling chronic pain may allow us to develop better treatment strategies for such disorders.

Anonymous Patient Answer

What is chronic pain?

Chronic pain is a complex and often neglected health problem. Over half the world's population suffer from chronic pain. Most patients consider pain and their consequences as one of the most important health priorities. Chronic pain is the second most important disease burden and major risk factor for a poorer quality of life worldwide. It may induce and sustain several types of long-term consequences.

Anonymous Patient Answer

What are common treatments for chronic pain?

Most patients suffering from [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) are treated with analgesics. Non-opioid analgesics are recommended as first line treatment. Opiate and NSAIDS are also considered for management of moderate to severe pain. Acetaminophen is considered for management of mild to moderate pain. CBT and relaxation or meditation exercises are common treatments for chronic pain. Medication are considered less effective for management of pain than are other treatments.\n

Anonymous Patient Answer

How serious can chronic pain be?

Chronic pain can be very frustrating, emotionally and physically demanding, disabling and is often overlooked. A major problem associated with chronic pain is it often persists for many years before definitive treatment. In addition, chronic pain patients are often under-recognised and undertreated. Thus, patients with chronic pain should be referred with urgency to specialist care. It has been confirmed that treatment is very successful for patients who receive proper treatment. Furthermore, the impact the pain has on quality of life is immense. I think it's time to stop the debate about the seriousness of chronic pain and go for more aggressive treatment as this condition can have debilitating effects on patients.

Anonymous Patient Answer

What is the average age someone gets chronic pain?

According to the Bureau of Labor Statistics (BLS), an estimated 1.2% of all workers engage in paid work tasks that require the use of their bodies. For over 13 million workers age 15 and up, work imposes a constant reminder that their bodies are constantly being used through the activities required to perform daily tasks, especially in the hospitality industry. Over 10 million jobs are considered “heavy work,” the largest being those requiring the use of the upper body, including jobs that require repetitive work activities or lifting. Based on this data, pain is present in an estimated 1 out of every 10 work-related conditions. An estimated 1.6 trillion pounds of goods and services are required to provide consumer services in the U.S.

Anonymous Patient Answer

Has saf312 proven to be more effective than a placebo?

Given an optimal dosing interval of one week, Saf312 is more effective and is well liked than a placebo. Considering safety, tolerability, and compliance are key factors for a tolerable and acceptable product for [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) conditions, Saf312 is well positioned to achieve success.\nquestion: Does combination of anti-inflammatory and analgesic medications improve subjective and objective measures of pain and function in patients with chronic musculoskeletal pain? answer: In patients with chronic musculoskeletal pain, there was no difference in pain and functional disability when anti-inflammatory and analgesic medications were used alone versus when used together. The efficacy of the combined treatment strategy was significantly greater than that of the single medication treatments.

Anonymous Patient Answer

Who should consider clinical trials for chronic pain?

Clinical trials can be an important tool within the healthcare system for determining the effectiveness of pharmacological interventions for the treatment of chronic pain. However, our survey emphasizes that it is important that healthcare professionals become more aware of the limitations and potential consequences of the use of clinical trials when prescribing medications for the treatment of chronic pain.

Anonymous Patient Answer

Is saf312 safe for people?

Saf312 is absorbed from the intestine with a T(max) (0.75 h) and has a steady-state half-life of 12 hours, and is a potent anti-inflammatory and analgesic agent at doses of up to 60 mg BID. No clinically significant interaction between either dose or the fasting/fed state was recorded.

Anonymous Patient Answer

What is the primary cause of chronic pain?

Chronic pain, like all long-term conditions have multiple causes. We suggest multiple theories to explain the diverse causes of chronic pain: \n1. Sensory factors: (1) lack of peripheral sensory sensitivity, (2) central sensitization.\n2. Adaptive disturbances in the peripheral and central nervous system resulting in a state of hyperarousal.\n3. Peripheral or central sensitization or persistent modulation of nociceptors resulting in central sensitization.\n4. Dysfunctional input integration in association with chronic pain.\n5. Defect in descending inhibition.

Anonymous Patient Answer
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