Rheumatic Diseases157NCT00922428

PASCOE-Agil HOM-Injektopas in the Treatment of Rheumatic Disorders

An observational study of Rheumatic Diseases and Arthralgia, run by Pascoe Pharmazeutische Praeparate GmbH.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this observational study is to give an overview of the use of PASCOE-Agil HOM-Injektopas in a 2-4 week treatment of rheumatic disorders. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatic Diseases, Arthralgia, Myalgias/Myopathy
How many people: 1,389 participants
Where: No sites listed yet
Study dates: Jan 2009to May 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Cohort of adult patients suffering from rheumatic diseases and relating symptoms who present themselves in German Primary Care Centers.

Who may be able to join

None listed.

Who cannot join

younger than 18 years
no Rheumatic disease with accompanying symptoms, e.g. arthralgia, myalgia, lumbago etc.
no treatment with PASCOE-Agil HOM-Injektopas

About this study

Official title: PASCOE-Agil HOM-Injektopas in the Treatment of Rheumatic Disorders: A Non-interventional Observational Study.

The purpose of this observational study is to give an overview of the use of PASCOE-Agil HOM-Injektopas in a 2-4 week treatment of rheumatic disorders.

Read the detailed description

The purpose of this observational study is to give an overview of the use of PASCOE-Agil HOM-Injektopas in a 2-4 week treatment of rheumatic disorders of different aetiology and localisation, displaying a variety of symptoms.

Efficacy and tolerability of the drug will be assessed. Special regard will be taken to the administration management in relation to the Summary of Product Characteristics (SmPC).

Conditions: Rheumatic Diseases, Arthralgia, Myalgias/Myopathy, Lumbago
Keywords: rheumatism, arthralgia, myalgia, lumbago, homoeopathy, injection, PASCOE-Agil HOM Injektopas, efficacy, tolerability, acceptance, safety
Medical subject headings: Rheumatic Diseases, Arthralgia, Myalgia, Muscular Diseases, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00922428
Study group	Role	What they receive
Observational group		Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Analog Scale (VAS)
Efficacy of the drug, measured by a Visual Analog Scale (VAS) Scale ranged from 0(=best, no pain) to 10(worst, intolerable pain) The VAS was filled by the patient.
Measured: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Tolerability of the Drug
Tolerability assessment of medical personnel End of study could by after 2 (visit 2) or after 4 weeks (Visit3).
It was measured by a score:
- very well tolerated (no side effects)
- moderately tolerated (mild side effects)
- poorly tolerated (marked side effects)
Measured: after end of study
Pain at Rest
Number of patient (in %) with an improvement of pain at rest between V1 and V2 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.
Measured: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Pain in Movement
Number of patients (in %) with an improvement of pain in movement between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.
Measured: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Pain After Rest
Number of patients (in %) with an improvement of pain after rest between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.
Measured: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Pain on Weight-bearing
Number of patients (in%) with an improvement of pain on weight-bearing between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.
Measured: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Morning Stiffness
Number of patients (in%) with an improvement of morning stiffness between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.
Measured: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Tenderness
Number of patients (in%) with an improvement of tenderness between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.
Measured: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Antalgic Position
Number of patients (in%) with an improvement of antalgic position V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.
Measured: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)

Secondary outcomes (1)

Acceptance of the Drug
Number of patients with good (patient was satisfied with the treatment, there was nothing to complain about) or poor (patient was not satisfied with the treatment, there were ADRs or other reasons) acceptance.
Measured: from enrollment until completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009May 2009

First posted17 Jun 2009 (estimated)
Study startJan 2009
Primary completionMay 2009
Study completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,389 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00922428
Sponsor's protocol ID: 157 A 07 PA
Acronym: 157
Status last verified: Apr 2015
First submitted: 16 Jun 2009
Last updated: 4 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip

All Rheumatic Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PASCOE-Agil HOM-Injektopas in the Treatment of Rheumatic Disorders: A Non-interventional Observational Study.
ClinicalTrials.gov ID: NCT00922428
Acronym / sponsor ID: 157 / 157 A 07 PA
Conditions: Rheumatic Diseases, Arthralgia, Myalgias/Myopathy, Lumbago
Keywords: rheumatism, arthralgia, myalgia, lumbago, homoeopathy, injection, PASCOE-Agil HOM Injektopas, efficacy
Study type: Observational
Recruitment status: Completed
Enrolment: 1,389 participants (actual)
Lead sponsor: Pascoe Pharmazeutische Praeparate GmbHIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 17 Jun 2009 (estimated)
Results: Posted 4 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this observational study is to give an overview of the use of PASCOE-Agil HOM-Injektopas in a 2-4 week treatment of rheumatic disorders.

Detailed description

Efficacy and tolerability of the drug will be assessed. Special regard will be taken to the administration management in relation to the Summary of Product Characteristics (SmPC).

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Observational group	–	–Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Cohort of adult patients suffering from rheumatic diseases and relating symptoms who present themselves in German Primary Care Centers.

Key inclusion criteria (0 listed)

Key exclusion criteria (3 listed)

younger than 18 years
no Rheumatic disease with accompanying symptoms, e.g. arthralgia, myalgia, lumbago etc.
no treatment with PASCOE-Agil HOM-Injektopas

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Visual Analog Scale (VAS)
Time frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Efficacy of the drug, measured by a Visual Analog Scale (VAS) Scale ranged from 0(=best, no pain) to 10(worst, intolerable pain) The VAS was filled by the patient.
Tolerability of the Drug
Time frame: after end of study
Tolerability assessment of medical personnel End of study could by after 2 (visit 2) or after 4 weeks (Visit3). It was measured by a score: * very well tolerated (no side effects) * moderately tolerated (mild side effects) * poorly tolerated (marked side effects)
Pain at Rest
Time frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Number of patient (in %) with an improvement of pain at rest between V1 and V2 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.
Pain in Movement
Time frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Number of patients (in %) with an improvement of pain in movement between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.
Pain After Rest
Time frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Number of patients (in %) with an improvement of pain after rest between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.
Pain on Weight-bearing
Time frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Number of patients (in%) with an improvement of pain on weight-bearing between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.
Morning Stiffness
Time frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Number of patients (in%) with an improvement of morning stiffness between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.
Tenderness
Time frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Number of patients (in%) with an improvement of tenderness between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.
Antalgic Position
Time frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Number of patients (in%) with an improvement of antalgic position V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.

1 secondary outcome

Acceptance of the Drug
Time frame: from enrollment until completion

Results and safety

Results posted to the registry on 4 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Observational Group	1,389	1,374

Primary outcome: Visual Analog Scale (VAS)

Time frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3). Mean (Standard Deviation). Unit: units on a scale

Measure	Observational (Visit 1) n = 1368	Observational Group (Visit 2) n = 1341	Observational Group (Visit 3) n = 1214
Value	6.57 (1.75)	4.23 (2.03)	2.61 (2.03)

Population analysed: due to character of an observational study: all patient who had a value, descriptive

Primary outcome: Tolerability of the Drug

Time frame: after end of study. Number. Unit: percentage of participants

Measure	Observational Group n = 1376
moderately/poorly tolerated	2.8
well tolerability	97.2

Population analysed: 1374 were full analysed, data of 2 patient were additionally analysed for tolerability

Primary outcome: Pain at Rest

Time frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3). Number. Unit: percentage of participants

Measure	Observational Group (V1/V2) n = 1060	Observational Group (V1/V3) n = 958	Observational Group (V2/V3) n = 945
Value	57.5	76.8	44.1

Population analysed: due to character of an observational study: descriptive, all patients who had an value

Primary outcome: Pain in Movement

Time frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3). Number. Unit: percentage of participants

Measure	Observational Group (V1/V2) n = 1322	Observational Group (V1/V3) n = 1201	Observational Group (V2/V3) n = 1185
Value	67.5	80.8	50.1

Population analysed: due to character of an observational study: descriptive, all patients who had an value

1 secondary outcome is reported in the full results.

Adverse events

Time frame: between January 2008 and the end of May 2008. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Observational Group	0 of 1,376 (0%)	23 of 1,376 (1.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rheumatic Diseases

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anja Braschoss, MD study director

Pascoe Pharmazeutische Praeparate GmbH

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatic Diseases and Arthralgia, run by Pascoe Pharmazeutische Praeparate GmbH.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) (time frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00922428.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2015.