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A randomized, double-blind, multicenter, placebo-controlled study to determine the efficacy and safety of BTDS compared to placebo in subjects with moderate to severe low back pain

A randomized, double-blind, multicenter, placebo-controlled study to determine the efficacy and safety of BTDS compared to placebo in subjects with moderate to severe low back pain

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220254
Enrollment
Unknown
Registered
2006-06-09
Start date
2006-06-09
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Low Back Pain

Interventions

investigational material(s) Generic name etc : BTDS INN of investigational material : Therapeutic category code : 114 Antipyretics, analgesics and anti-inflammatory agents Dosage and Administration f

Sponsors

MUNDIPHARMA K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: [Inclusion Criteria] - Males or females age 20 years or older. - Clinical diagnosis of low back pain for 4 weeks or longer with non-malignant pain etiology. [Exclusion Criteria] - Subjects who have a current or past history of chronic disease(s), in addition to low back pain, requiring frequent analgesic therapy(e.g.headache, fibromyalgia, gout, rheumatoid arthritis, osteoarthritis and diabetic neuropathy).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
The time to the development of inadequate analgesia.—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026