Trial Outcomes & Findings for PASCOE-Agil HOM-Injektopas in the Treatment of Rheumatic Disorders (NCT NCT00922428)

NCT ID: NCT00922428

Last Updated: 2015-05-04

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 1389 participants
• Primary outcome timeframe: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
• Results posted on: 2015-05-04

Participant Flow

The observational study was carried out by medically-trained doctors who generally treated patients with rheumatic disorders. By choosing a range of different medical specialties - predominantly orthopaedics, rheumatology, general medicine, sports medicine and family doctors - it was ensured that a broad spectrum of patients was recruited.

The observational study was carried out between January 2008 and the end of May 2008 by 280 therapists. The non-interventional character of an observational study meant that no exact timeframe for the treatment of patients was specified.

Participant milestones

Measure	Observational Group Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
Overall Study STARTED	1389
Overall Study COMPLETED	1374
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Measure	Observational Group Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
Overall Study retrospective/extremely implausible data	2
Overall Study no medication use or questionable use	13

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Observational Group n=1374 Participants Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
Age, Categorical <=18 years	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	791 Participants n=5 Participants
Age, Categorical >=65 years	580 Participants n=5 Participants
Age, Continuous	59.9 years STANDARD_DEVIATION 15.5 • n=5 Participants
Sex/Gender, Customized male	437 participants n=5 Participants
Sex/Gender, Customized female	926 participants n=5 Participants
Sex/Gender, Customized unknown	11 participants n=5 Participants
Region of Enrollment Germany	1374 participants n=5 Participants

PRIMARY outcome

Timeframe: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)

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

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.

Outcome measures

Measure	Observational (Visit 1) n=1368 Participants VAS of the observational group at beginning	Observational Group (Visit 2) n=1341 Participants VAS of the observational group at visit 2	Observational Group (Visit 3) n=1214 Participants VAS of the observational group at visit 3
Visual Analog Scale (VAS)	6.57 units on a scale Standard Deviation 1.75	4.23 units on a scale Standard Deviation 2.03	2.61 units on a scale Standard Deviation 2.03

PRIMARY outcome

Timeframe: after end of study

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

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)

Outcome measures

Measure	Observational (Visit 1) n=1376 Participants VAS of the observational group at beginning	Observational Group (Visit 2) VAS of the observational group at visit 2	Observational Group (Visit 3) VAS of the observational group at visit 3
Tolerability of the Drug moderately/poorly tolerated	2.8 percentage of participants	—	—
Tolerability of the Drug well tolerability	97.2 percentage of participants	—	—

PRIMARY outcome

Timeframe: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)

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

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.

Outcome measures

Measure	Observational (Visit 1) n=1060 Participants VAS of the observational group at beginning	Observational Group (Visit 2) n=958 Participants VAS of the observational group at visit 2	Observational Group (Visit 3) n=945 Participants VAS of the observational group at visit 3
Pain at Rest	57.5 percentage of participants	76.8 percentage of participants	44.1 percentage of participants

PRIMARY outcome

Timeframe: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)

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

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.

Outcome measures

Measure	Observational (Visit 1) n=1322 Participants VAS of the observational group at beginning	Observational Group (Visit 2) n=1201 Participants VAS of the observational group at visit 2	Observational Group (Visit 3) n=1185 Participants VAS of the observational group at visit 3
Pain in Movement	67.5 percentage of participants	80.8 percentage of participants	50.1 percentage of participants

PRIMARY outcome

Timeframe: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)

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

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.

Outcome measures

Measure	Observational (Visit 1) n=1110 Participants VAS of the observational group at beginning	Observational Group (Visit 2) n=1012 Participants VAS of the observational group at visit 2	Observational Group (Visit 3) n=1002 Participants VAS of the observational group at visit 3
Pain After Rest	60.2 percentage of participants	78.6 percentage of participants	49.8 percentage of participants

PRIMARY outcome

Timeframe: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)

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

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.

Outcome measures

Measure	Observational (Visit 1) n=1288 Participants VAS of the observational group at beginning	Observational Group (Visit 2) n=1165 Participants VAS of the observational group at visit 2	Observational Group (Visit 3) n=1151 Participants VAS of the observational group at visit 3
Pain on Weight-bearing	64.1 percentage of participants	79.1 percentage of participants	50.4 percentage of participants

PRIMARY outcome

Timeframe: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)

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

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.

Outcome measures

Measure	Observational (Visit 1) n=941 Participants VAS of the observational group at beginning	Observational Group (Visit 2) n=864 Participants VAS of the observational group at visit 2	Observational Group (Visit 3) n=853 Participants VAS of the observational group at visit 3
Morning Stiffness	54.4 percentage of participants	74.5 percentage of participants	42.9 percentage of participants

PRIMARY outcome

Timeframe: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)

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

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.

Outcome measures

Measure	Observational (Visit 1) n=1155 Participants VAS of the observational group at beginning	Observational Group (Visit 2) n=1036 Participants VAS of the observational group at visit 2	Observational Group (Visit 3) n=1023 Participants VAS of the observational group at visit 3
Tenderness	64.5 percentage of participants	80.8 percentage of participants	50.3 percentage of participants

PRIMARY outcome

Timeframe: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)

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

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.

Outcome measures

Measure	Observational (Visit 1) n=1042 Participants VAS of the observational group at beginning	Observational Group (Visit 2) n=931 Participants VAS of the observational group at visit 2	Observational Group (Visit 3) n=921 Participants VAS of the observational group at visit 3
Antalgic Position	61.3 percentage of participants	79.4 percentage of participants	43.4 percentage of participants

SECONDARY outcome

Timeframe: from enrollment until completion

Population: due to the character of an observational study: descriptive

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.

Outcome measures

Measure	Observational (Visit 1) n=1374 Participants VAS of the observational group at beginning	Observational Group (Visit 2) VAS of the observational group at visit 2	Observational Group (Visit 3) VAS of the observational group at visit 3
Acceptance of the Drug good acceptance	90.5 percentage of participants	—	—
Acceptance of the Drug poor acceptance	8.7 percentage of participants	—	—

Adverse Events

Observational Group

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Observational Group n=1376 participants at risk Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
Injury, poisoning and procedural complications Injection site reaction	1.7% 23/1376 • Number of events 23 • between January 2008 and the end of May 2008

Additional Information

Anja Braschoss

Pascoe pharmazeutische Präparate GmbH

Phone: 0049 641 7960100

Email: KlinischeForschung@pascoe.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place