Placebo and active controlled, double dummy phase II study to prove efficacy of Aspirin (1000 mg solid dose) in treatment of acute low back pain.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-005079-40-GB

Enrollment

300

Registered

2005-08-18

Start date

2005-11-03

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute body pain, specifically low back pain

Interventions

Product Name: Acetylsalicylic acid Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Acetylsalicylic acid Other descriptive name: Aspirin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Ambulatory male or female, aged 18 – 70 years - Body mass index [BMI] ranging in-between 18 and 30 kg/m² - Normal blood pressure (stable, if medically controlled) - Subjects written informed consent has to be obtained prior to inclusion into the study - Patients suffering from pain, rated on a 11 point numerical pain scale with a minimum of 4 - Low back pain, localized below the costal margin and above the inferior gluteal folds, either as acute low back pain, or as chronic or intermittent low back pain - No specific diseases as of the decision of the Investigator (e.g. as defined by red flags) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Known hypersensitivity or other contraindication to ASA, salicylates, or other NSAIDs - Serious physical illness especially uncontrolled disorders of kidney, liver, lung, heart or brain function, neurological disorders or severe chronic or terminal disease - Patient may have received treatment with an anesthetic and/or NSAID for the acute phase within 48 to 72 hours before study entry, but have to stop taking any of these drugs at least 12 hours before entry to study. - Pregnant or lactating women, or sexually active women of childbearing potential unless using effective contraception - Abuse of alcohol or addictive substances - Ingestion of any analgesic drug within previous 12 hours. - Participation in any other clinical study within the previous 30 days - Previous participation in this study

Design outcomes

Primary

Measure	Time frame
Secondary Objective: - Safety - Efficacy: During the entire treatment period, pain scales, pain relief scales and efficacy evaluation will be requested. Secondary parameters that will be evaluated are TOTPAR (total pain relief after 120 hours), SPID (pain intensity difference after 120 hours) and Overall Efficacy in order to establish: - Total dose used over 5 days - Overall efficacy at days 6 or 7 - Overall efficacy of Follow Up Period at day 14 - Time till use of rescue medication ;Main Objective: To show that there is a statistical significant superiority of Aspirin 1000 mg solid dose three times daily over Placebo, when comparing the area under the curve (AUC) of the baseline adjusted pain intensity for the first 48 hours after start of treatment.;Primary end point(s): The primary efficacy criteria of this study is the area under the curve (AUC) of the baseline adjusted pain intensity (PI) score plotted versus time over 48 hours after first dose (FD).	—

Measure

Time frame

Secondary Objective: - Safety - Efficacy: During the entire treatment period, pain scales, pain relief scales and efficacy evaluation will be requested. Secondary parameters that will be evaluated are TOTPAR (total pain relief after 120 hours), SPID (pain intensity difference after 120 hours) and Overall Efficacy in order to establish: - Total dose used over 5 days - Overall efficacy at days 6 or 7 - Overall efficacy of Follow Up Period at day 14 - Time till use of rescue medication ;Main Objective: To show that there is a statistical significant superiority of Aspirin 1000 mg solid dose three times daily over Placebo, when comparing the area under the curve (AUC) of the baseline adjusted pain intensity for the first 48 hours after start of treatment.;Primary end point(s): The primary efficacy criteria of this study is the area under the curve (AUC) of the baseline adjusted pain intensity (PI) score plotted versus time over 48 hours after first dose (FD).

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Countries

Germany, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026