# A Study of the Efficacy and Safety of Tramadol HCl/Acetaminophen, Hydrocodone Bitartrate/Acetaminophen and Placebo in Patients With Pain From an Ankle Sprain With a Partial Torn Ligament

> **NCT00236535** · PHASE3 · COMPLETED · sponsor: **Johnson & Johnson Pharmaceutical Research & Development, L.L.C.** · enrollment: 603 (actual)

## Conditions studied

- Sprains and Strains
- Pain

## Interventions

- **DRUG:** tramadol HCl + acetaminophen; hydrocodone bitartrate + acetaminophen; placebo

## Key facts

- **NCT ID:** NCT00236535
- **Lead sponsor:** Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2003-12
- **Primary completion:** —
- **Final completion:** 2004-10
- **Target enrollment:** 603 (ACTUAL)
- **Last updated:** 2011-06-10

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00236535

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00236535, "A Study of the Efficacy and Safety of Tramadol HCl/Acetaminophen, Hydrocodone Bitartrate/Acetaminophen and Placebo in Patients With Pain From an Ankle Sprain With a Partial Torn Ligament". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT00236535. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*