Condition category
Musculoskeletal Diseases
Date applied
19/09/2006
Date assigned
03/10/2006
Last edited
04/10/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr V P Pandey

ORCID ID

Contact details

A-4
MIG
A.B.Road
Indore
Madhya Pradesh
452001
India
+91 0731 2532164
vppandey@sancharnet.in

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ACELO-0605

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the efficacy and tolerability of aceclofenac injection as compared to diclofenac injection in subjects suffering from acute lumago.

Ethics approval

Institutional Ethic Committee approval taken for the study.

Study design

Two arm, open-labeled, multi-centric, randomised, comparative trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Acute Lumbago

Intervention

Group one - intervention treatment: Aceclofenac injection 150 mg twice daily (b.i.d) for two days.
Group two - intervention treatment: Diclofenac injection 75 mg b.i.d for two days.

Intervention type

Drug

Phase

Not Specified

Drug names

Aceclofenac

Primary outcome measures

1. Assessment of overall response to study drugs.
2. Assessment of overall response of subjects to the drug.

Secondary outcome measures

1. Assessment of changes in VAS pain at 30 minutes, one, two, four, eight, 24 and 48 hours after the treatment compared with the baseline.
2. Assessment to degree of improvement after eight hours, 24 hours and 48 hours of treatment compared to baseline in:
a. pain on movement using a four point scale
b. functional impairment using a four point scale
c. pain on pressure in the lumbosacral region using a four point scale
d. muscle contraction in the lumbosacral region using a four point scale

Overall trial start date

02/05/2006

Overall trial end date

10/08/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients of either sex, aged over 18 years suffering from acute lumbago (that began less than 48 hours before study entry)
2. Pain intensity more than 50 mm on a 100 mm Visual Analogue Scale (VAS)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

Patients with history of:
1. Recurrent peptic ulcer or duodenal ulcer
2. Gastrointestinal bleeding or other bleeding disorders
3. Significant renal or hepatic impairment
4. Any significant abnormality on preclinical trial screening
5. Pregnant and lactating mothers
6. Patients requiring aspirin at any dose, corticosteroids, anticoagulants, ticlopidine hydrochloride or other drugs affecting platelet function and coagulation, and patients taking hormonal contraceptives or patients allergic to Non Steroidal Anti-Inflammatory Drugs (NSAIDs)

Recruitment start date

02/05/2006

Recruitment end date

10/08/2006

Locations

Countries of recruitment

India

Trial participating centre

A-4, MIG
Madhya Pradesh
452001
India

Sponsor information

Organisation

Venus Remedies Limited (India)

Sponsor details

Intellectual Scientific Division
Research and Development Centre
51-52 Industrial Area
Phase-1
Panchkula
Haryana
134113
India
+91 17 22561244
operations@venusremedies.com

Sponsor type

Industry

Website

http://www.venusremedies.com

Funders

Funder type

Industry

Funder name

Venus Remedies Limited (India)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes