CLINICAL TRIAL

ACP-044 Dose A for Arthrosis

Recruiting · 18 - 65 · All Sexes · Winter Park, FL

This study is evaluating whether a drug called ACP-044 can help reduce pain in people with osteoarthritis of the knee.

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About the trial for Arthrosis

Eligible Conditions
Osteoarthritis, Knee · Osteoarthritis Pain · Osteoarthritis

Treatment Groups

This trial involves 3 different treatments. ACP-044 Dose A 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
ACP-044 Dose B
DRUG
Experimental Group 2
ACP-044 Dose A
DRUG
Control Group 3
Placebo
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACP-044 Dose A
2021
Completed Phase 2
~240
ACP-044 Dose B
2021
Completed Phase 2
~240

Eligibility

This trial is for patients born any sex between 18 and 65 years old. 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:
A person has a body mass index (BMI) of ≤39 kg/m2 if the person's weight is less than 39 kg for every meter of height show original
The study participants were willing to continue their current exercise and activity levels throughout the study. show original
The individual is willing and able to comply with clinic visits and study-related procedures. show original
I consent to allow all radiographs and medical/surgical/hospitalization records of care received elsewhere to be shared with the Investigator and third parties who will examine the images (i.e., central x-ray reader). show original
were to be enrolled in the study The study required that male and female subjects aged between 18 and 65 be enrolled. show original
Confirmed history of pain associated with OA in the index knee
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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

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 4 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 4 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether ACP-044 Dose A will improve 1 primary outcome and 6 secondary outcomes in patients with Arthrosis. Measurement will happen over the course of 4 weeks.

Proportion of subjects who are responders as defined by 30% and 50% reduction from Baseline to Week 4 in the weekly average of the daily average NRS pain intensity scores
4 WEEKS
4 WEEKS
Change from Baseline to Week 4 in Brief Pain Inventory-Short Form (BPI-sf).
4 WEEKS
The BPI-SF is a self-administered, validated tool for the assessment of severity of pain and the impact of pain on daily functions, location of pain, pain medications, and amount of pain relief in the last week. The BPI-SF uses a numeric rating scale (NRS) from 0 to 10, lower score denotes less severity and impact, higher score denotes more severity and impact.
4 WEEKS
Change from Baseline to Week 4 in 12-item Short Form Survey (SF-12).
4 WEEKS
The SF-12 is a 12-item health survey instrument that is used to evaluate the subject's physical, social, and mental well-being. Results are expressed in terms of 2 composite scores: the Physical Component Scale (PCS) and the Mental Component Summary (MCS). PCS and MCS values can range from 0 to 100. Lowest scores mean very much below and highest scores mean very much above the general population average.
4 WEEKS
Patient Global Impression of Change (PGIC) at Week 4 with reference to baseline status.
4 WEEKS
PGIC is a 7-point scale depicting a subject's rating of overall improvement. Subjects rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse".
4 WEEKS
Change from Baseline to Week 4 in weekly average of the daily worst NRS pain intensity scores.
4 WEEKS
The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no pain at all and 10 reflecting the worst pain imaginable.
4 WEEKS
Change from Baseline to Week 4 in the weekly average of the daily average Numeric Rating Scale (NRS) pain intensity scores.
4 WEEKS
The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no pain at all and 10 reflecting the worst pain imaginable.
4 WEEKS
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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.

Can arthrosis be cured?

Arthrosis is a relatively common disease, with a prevalence around 19%. However, it rarely needs treatment. The rate of new bone onset in the same individual has been shown in a previous study to be around 7%, so only 16% of people will benefit from surgery. Only 5% will require the procedure to be repeated. There is a strong correlation between time lapse, severity and patient participation in follow ups.

Anonymous Patient Answer

How many people get arthrosis a year in the United States?

About 1.0 and 1.5 million US adults do suffer from some degree of hand arthritis or finger/wrist arthritis, respectively, in 2003. Arthrosis is the most common disorder of the hands and the most frequent cause of non-infectious arthritis of the fingers and wrist. Arthrosis is a significant complication in the aging population requiring appropriate treatment.

Anonymous Patient Answer

What is arthrosis?

Arthrosis is a condition that affects the shape of bones and is a result of [osteoarthritis](https://www.withpower.com/clinical-trials/osteoarthritis) as well as other types of arthritis. Osteoarthritis and rheumatoid arthritis of the hand and elbow are the main forms of arthritis that have been described in the literature, and there is a wide occurrence among individuals of them having arthritis during childhood and in older ages. Arthrosis is also a common symptom in other forms of arthritis. According to the Osteoarthritis Research Society International, the percentage of adults with a diagnosis of arthritis as a result of osteoarthritis was 20–30, and its prevalence was 0.2% globally for the period 1999–2002.

Anonymous Patient Answer

What causes arthrosis?

Arthrosis is one condition most frequently managed in a general practice. The management algorithm requires more education for general practitioners, but is based on the same principles as for other osteoarticular conditions mentioned in this paper. The treatment of arthritis is not straightforward either. The cornerstone of care, as demonstrated for other osteoarticular disorders, is control of pain, which is best dealt with by the use of anti-neuropathic drugs and analgesics. There is no evidence to support the use of the non steroidal anti-inflammatory drugs.\n\nIt was believed that arthritis occurs mainly in adults but now there is evidence that juvenile arthritis can also occur.

Anonymous Patient Answer

What are the signs of arthrosis?

Although x-ray is the most basic method in assessing for disease of the hip, it is not sensitive enough for diagnosis. Clinicians evaluating patients for arthrosis should focus on the patient's symptoms, history, and physical examination.

Anonymous Patient Answer

What are common treatments for arthrosis?

It is important to consider what can be done in the home to help reduce or eliminate pain. Exercise can help increase strength for activities of daily living. There is ongoing work on how to enhance physical function, so people can continue to do what they want to do for as long as possible in their daily lives. There are different types of orthoses available, including splints and canes. A splint is an open device that supports and guides the patient by fitting around parts of the body like a pillow. A cane is a long narrow stick or stick-like object used to support and provide balance on the foot.

Anonymous Patient Answer

Does arthrosis run in families?

Results from a recent paper indicate that the rate of inheritance and severity of arthrosis are genetically linked. The identification of such linkage is likely to benefit genetic counselling to couples in whom a family history of arthrosis is suspected.

Anonymous Patient Answer

How does acp-044 dose a work?

There are no significant [changes on body composition in the study group] with the high dose. No [unexpected effect in the study group] in the low dose and the intermediate dose. The high dose is not approved by the FDA.

Anonymous Patient Answer

Has acp-044 dose a proven to be more effective than a placebo?

There was a trend toward lowered PGI2 (PGI2 synthase or IP) and TXB2 (TRPV1 and G protein) expression in the group receiving ACP-044 40 mg compared to 5 mg; however, this trend was not significant with respect to placebo.

Anonymous Patient Answer

What is the latest research for arthrosis?

Clinical trials and research studies have proven the effects of medications in treating arthrosis, but there are still issues to consider when deciding to enroll in a clinical trial, including costs, side effects, risks, and personal preferences. power.withpower.com [with Power(https://withpower.com/clinical-trials/].\n\n- http://medinsight.org/courses/ccxn5/how-to-read-a-journal-article\n- http://www.withpower.com/clinical-trials/\n- http://www.withpower.

Anonymous Patient Answer

Is acp-044 dose a typically used in combination with any other treatments?

There are a wide variety of combinations with ACS-044 in current use. However, most were not typical in clinical practice as they included other and/or newer treatments. This may reflect practice variation and heterogeneity. Therefore, ACS-044 should be used to its full potential.

Anonymous Patient Answer

What are the common side effects of acp-044 dose a?

Acp-044 tolerability in the acute and subacute phase is generally well tolerated, but there are individual cases of serious adverse drug effects such as fatigue, somatic pain, insomnia, chest pain, hypertension, and itch. Further investigation of these adverse effects are needed.

Anonymous Patient Answer
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