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Completed

NCT Number: NCT01028079

Placebo and Active Controlled, Double Dummy Study to Prove Efficacy of Aspirin in Treatment of Acute Low Back Pain

The purpose of this study is to determine the efficacy and safety of 1000 mg Aspirin (the study medication) by comparing it to placebo (the control group without active substance) or 400 mg Ibuprofen (the control group with an active substance) in treating the symptoms of back pain. The study is designed to develop a treatment method against back pain which will have more advantages for patients than the methods that are currently available.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bad Lippspringe, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ambulatory male or female, 18 to 70 years of age
  • Body mass index ranging in-between 18 and 30 kg/m²
  • Normal blood pressure
  • Patients suffering from low back pain
  • 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

Exclusion criteria

  • Hypersensitivity to acetylsalicylic, salicylates, or other Non Steroidal Anti-inflammatory drugs
  • Serious physical illness especially uncontrolled disorders of kidney, liver, lung, heart or brain function, neurological disorders or severe chronic or terminal disease
  • Pregnancy or lactation period
  • Abuse of alcohol or addictive substances

Treatment and study plan

Acetylsalicylic acid (Aspirin, BAYE4465)

Drug

Aspirin 1000 mg (solid dose caplet) to be given three times daily as for 2 consecutive days (48 hours), followed by Aspirin 1000 mg (solid dose caplet) to be taken as per need, but not more than three times daily for the following 3 days (72 hours). Total treatment period has not to exceed 5 days and total daily dose has not to exceed 3000 mg Aspirin.

Ibuprofen

Drug

Ibuprofen 400 mg caplet to be given three times a day as for 2 consecutive days (48 hours), followed by ibuprofen 400 mg caplet to be given as per need, but not more than three times a day for the following 3 days (72 hours). Total treatment period has not to exceed 5 days and total daily dose has not to exceed 1200 mg ibuprofen.

Placebo

Drug

Placebo (two placebos: Placebo Aspirin and Placebo Ibuprofen) to be given three times a day for a maximum of 5 consecutive days in the same regimen as for Experimental Drug and Active Comparator.

Primary outcomes

  1. Area under the curve of the baseline adjusted pain intensity curve over the initial 48 hours (AUC-PI0-48hours) after first dosing

    Time frame: 48 hours

Secondary outcomes

  1. Total pain relief 6, 72, 96 and 120 hours after first dosing

    Time frame: 6, 72, 96 and 120 hours

  2. Pain intensity relief over initial 6 hours

    Time frame: 6 hours

  3. Pain intensity difference after 48, 72, 96 and 120 hours after first dosing

    Time frame: 48, 72, 96 and 120 hours

  4. Overall efficacy after 48, 72, 96 and 120 hours after first dosing

    Time frame: 48, 72, 96 and 120 hours

  5. Total dose used over 5 days

    Time frame: 5 days

  6. Time till use of rescue medication

    Time frame: 5 days

  7. Safety - assessment of adverse events

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Placebo and Active Controlled, Double Dummy Phase III Study to Prove Efficacy of Aspirin (1000 mg Solid Dose) in Treatment of Acute Low Back Pain.

Important dates

Study start
2005
Study completion
2006
First posted
Dec 9, 2009
Registry last updated
Dec 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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