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NCT01383954 · ClinicalTrials.gov registry record · Phase 4

The Efficacy of Diclofenac Gel for Breakthrough Pain and the Neuropathic Components of Pain in Knee Osteoarthritis

A Phase 4 study of Knee Osteoarthritis, sponsored by Brigham and Women's Hospital.

Completed
Registry status
Phase 4
Development phase
52
Enrollment target
1
Study location

NCT01383954: Completed Phase 4 study of Knee Osteoarthritis, sponsored by Brigham and Women's Hospital.

NCT01383954 is a Phase 4 study of Knee Osteoarthritis that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 52 participants, below the 304-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01383954, a Phase 4 study of Knee Osteoarthritis, has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
Phase 4
Development phase
52 participants
Enrollment target
1
Study location

Study Summary

The purpose of this proposed study is to conduct a trial with knee osteoarthritis (OA) patients using the diclofenac gel.

Primary Outcome

Participants assessed their knee pain using a visual analog scale (VAS) where 0=no pain and 100=worst possible pain. Pain scores were recorded in an electronic diary prior to and 4 hours after the first daily application of diclofenac gel for breakthrough pain. The daily percent change in pain scores over the 7 days prior to Week 1 were averaged. Percent change from Baseline (average pain score 7 days prior to first treatment) was calculated as (value at baseline - value at post-baseline visit)

Conditions Studied

Interventions

  • DRUG Diclofenac Gel

Study Locations (1)

Massachusetts

  • Brigham and Women's Hospital - Chestnut Hill

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2011-06
Est. Completion 2012-12
Phase Phase 4
Brigham and Women's Hospital

937 total trials

What the finished NCT01383954 record still lists

NCT01383954 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 304-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (83% lower).

The record links to 1 condition, with Knee Osteoarthritis appearing as the primary indexed condition, and to 1 intervention - of which Diclofenac Gel is the first listed.

NCT01383954 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01383954 about?

NCT01383954 is a clinical study titled "The Efficacy of Diclofenac Gel for Breakthrough Pain and the Neuropathic Components of Pain in Knee Osteoarthritis". The purpose of this proposed study is to conduct a trial with knee osteoarthritis (OA) patients using the diclofenac gel.

What is the current status of trial NCT01383954?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 52 participants. The study started on 2011-06. Estimated completion is 2012-12.

What conditions does trial NCT01383954 study?

This clinical trial studies the following conditions: Knee Osteoarthritis.

What interventions are being tested in trial NCT01383954?

The interventions under investigation include: Diclofenac Gel (DRUG).

Who is sponsoring clinical trial NCT01383954?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01383954 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Knee Osteoarthritis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01383954's enrollment target sits among peer trials

52 67th of 101 higher than 35 of 101 other Knee Osteoarthritis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Knee Osteoarthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01383954, the US trial registry maintained by the National Library of Medicine. NCT01383954 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.