Study on the Effectiveness and Safety of AP707 and Naproxen for Patients with Chronic Back Pain

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What is this study about?

This clinical trial is focused on evaluating the effectiveness and safety of a treatment called AP707 for individuals experiencing chronic back pain. Chronic back pain is a long-lasting pain in the back that persists for at least three months. The study aims to determine how well AP707 works as an additional treatment for managing this type of pain.

Participants in the study will be divided into two groups. One group will receive the AP707 treatment, while the other group will receive a placebo. The study will last for a total of 52 weeks, with assessments at various points to monitor changes in pain levels and overall well-being. The main goal is to see if AP707 can help reduce pain and improve the quality of life for those with chronic back pain.

Throughout the study, participants will be asked to report their pain levels and any changes they experience. The study will also look at other factors such as sleep quality, psychological distress, and overall health. By the end of the study, researchers hope to gather valuable information on the potential benefits of AP707 for managing chronic back pain.

1 joining the study

Upon joining the study, you will be required to sign and date an informed consent form. This document confirms your understanding and agreement to participate in the clinical trial.

You will complete the painDETECT questionnaire, which assesses your pain level. A score of 20 or more is necessary to proceed.

2 initial assessment

An initial assessment will be conducted to confirm that you have experienced chronic back pain for at least three months.

Your current pain intensity will be measured using the Numeric Rating Scale (NRS), where you will rate your pain from 0 to 10. A score greater than 5 is required.

3 randomized treatment phase

You will be randomly assigned to one of two groups: one receiving the active treatment, AP707, and the other receiving a placebo.

The treatment will be administered as a sublingual spray, which means it is sprayed under the tongue. The appearance of the spray is brown-beige with a sweet and slightly fruity odor.

4 treatment week 14

At the end of the first treatment phase, your pain level will be reassessed using the NRS to evaluate any changes from the baseline.

Additional assessments will include the Neuropathic Pain Symptom Inventory (NPSI) questionnaire to measure changes in pain symptoms.

5 treatment week 26

At the end of the second treatment phase, your pain level will again be measured using the NRS.

Further assessments will be conducted to evaluate changes in psychological distress, quality of life, and sleep quality.

6 treatment week 52

At the end of the third treatment phase, a final assessment of your pain level will be conducted using the NRS.

The study will also evaluate changes in your overall impression of change, quality of life, and any adverse events experienced during the trial.

Who Can Join the Study?

Signed and dated informed consent form.
Completed painDETECT questionnaire with a score of 20 or more. This is a survey to help understand your pain.
Patients with chronic back pain for at least 3 months.
Female and male patients who are 18 years or older.
Patients with more than 1 year life expectancy.
Patients with optimized sCPT on study entry. This means your current treatment plan is stable and as good as it can be.
Willingness to use reliable contraception during the study and for three months after taking the last study medication.
Good command of the German language to understand questionnaires in German.
Current moderate to severe pain with pain intensity greater than 5 on a Numeric Rating Scale (NRS, 0 – 10). This means you have a significant need for more pain treatment.
Completed QUISS (Quantification Inventory for Somatoform Syndromes) questionnaire with a score of 45 or less. This is another survey to assess your symptoms.

Who Cannot Join the Study?

Patients with any other significant health condition that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent surgery or are planning to have surgery during the study period.
Patients who are pregnant or breastfeeding.
Patients with a history of substance abuse or addiction.
Patients who are unable to comply with the study procedures.
Patients with known allergies to the study medication or its ingredients.
Patients with severe mental health disorders that are not well controlled.
Patients who have been diagnosed with cancer in the past five years.
Patients with severe liver or kidney disease.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medical University Of Vienna	Vienna	Austria
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Universitaet Leipzig	Leipzig	Germany

Other Sites

Site Name	City	Country
Landeskrankenanstalten-Betriebsgesellschaft Kabeg	Klagenfurt am Wörthersee	Austria
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Kepler Universitaetsklinikum GmbH	Linz	Austria
Klinikum Dortmund gGmbH	Dortmund	Germany
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
Hausarztzentrum Butendorf	Gladbeck	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Saarland University Hospital	Homburg	Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH	Villingen-Schwenningen	Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Staedtisches Klinikum Karlsruhe gGmbH	Karlsruhe	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Oberoesterreichische Gesundheitsholding GmbH	Steyr	Austria
Klinikum Wels-Grieskirchen GmbH	Wels	Austria
Ruhr University	Bochum	Germany
Christliches Klinikum Unna gGmbH	Unna	Germany
BG Klinikum Unfallkrankenhaus Berlin gGmbH	Berlin	Germany
Algesiologikum MVZ GmbH	Munich	Germany
BG Klinikum Hamburg gGmbH	Hamburg	Germany
Westmecklenburg Klinikum Helene von Buelow GmbH	Hagenow	Germany
Noe LGA Gesundheit Region Mitte GmbH	Tulln An Der Donau	Austria
Medicross MVZ GmbH	Neckarsulm	Germany
Schwerpunktpraxis Fuer Schmerztherapie Berufsausübungsgemeinschaft GbR	Ulm	Germany
Schmerztherapiezentrum Brau Michel	Osnabrück	Germany
Ueberoertliche Berufsausuebungsgemeinschaft Schmerz Und Palliativzentrum Rhein Main GbR	Frankfurt	Germany
BG Klinikum Duisburg gGmbH	Duisburg	Germany
Schmerzzentrum Inn-Salzach	Burghausen	Germany
Schmerzzentrum Bocholt	Bocholt	Germany
Praxis Fur Neurologie	Hoppegarten	Germany
Universitatsklinikum Würzburg AöR	Wuerzburg	Germany
Praxisklinik Dr. Ibrahim & Kollegen	Munich	Germany
Schmerzkompetenzzentrum	Bad Vöslau	Austria
BG Klinik Tübingen	Tuebingen	Germany
Schmerzzentrum Geldern	Geldern	Germany
Uhehhxoxkgnbcxwcxjhyo Gktnyuv uwi Mzysimk Ginp	Marburg	Germany
Kcgnpe Ohitxzsw	Oberwart	Austria
Zurgxnb fld Sljilivh uon Pnyfnfnssogoevgg Svfizecx	Schwerte	Germany
Gjclbmsxnukbaoxjlkf Maetnch Jcglmp und Awwxwcn Lbjftk	Borken	Germany
Mphsrv Htqbwnrt Hqiak Uwyqdccwbxkwdjsbkyuz dnl Rxakjylssbkcdpex Brdkod	Herne	Germany
Utddslilsjyjbvlufozqz Eppmw Avm	Essen	Germany
Bnlavhraufgyztbvfzpubmydsf Uolhzizsloexybamhxqhu Bxkjpxxwdbnse gwgxb	Bochum	Germany
Ukhsutqnytfctfkzjmryz Axhobhdn	Augsburg	Germany
Gwxxrh Uyfubsxuby Ftvvqolnb	Frankfurt	Germany

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.05.2023
Germany	Not recruiting	01.05.2023

Trial locations

Investigated drugs:

AP707 is a medication being tested to see how well it works for people who have long-lasting back pain. It is used in addition to other treatments that patients might already be receiving. The goal is to find out if adding AP707 can help reduce pain and improve the quality of life for those suffering from chronic back pain. This trial is focused on understanding how effective AP707 is and how well patients can tolerate it when used alongside their current pain management plan.

Chronic Back Pain – Chronic back pain is a persistent pain that occurs in the back, lasting for more than three months. It can be caused by various factors, including muscle or ligament strain, bulging or ruptured disks, arthritis, or skeletal irregularities. The pain may be felt as a dull ache, sharp pain, or burning sensation, and it can vary in intensity. Over time, chronic back pain can lead to decreased mobility and flexibility, making it difficult to perform daily activities. The condition may also contribute to psychological distress, such as anxiety or depression, due to its persistent nature. As the pain continues, it can affect sleep quality and overall quality of life.

Trial ID:

2022-502151-54-00

Protocol code:

DISCOVER_(MBP)

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of AP707 and Naproxen for Patients with Chronic Back Pain

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?