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

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Bayer

Status and phase

Completed
Phase 3

Conditions

Low Back Pain

Treatments

Drug: Ibuprofen
Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

338 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

338 participants in 3 patient groups, including a placebo group

Arm 2
Active Comparator group
Treatment:
Drug: Ibuprofen
Arm 3
Placebo Comparator group
Treatment:
Drug: Placebo
Arm 1
Experimental group
Treatment:
Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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