Evaluation of efficacy and safety of aceclofenac injection in the treatment of acute lumbago: a randomised comparative open-labeled multi-centric trial

ISRCTN	ISRCTN99850066
DOI	https://doi.org/10.1186/ISRCTN99850066
Protocol serial number	ACELO-0605
Sponsor	Venus Remedies Limited (India)
Funder	Venus Remedies Limited (India)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr V P Pandey
Scientific

A-4, MIG
A.B.Road
Indore
Madhya Pradesh
452001
India

Phone	+91 0731 2532164
Email	vppandey@sancharnet.in

Primary study design	Interventional
Study design	Two arm, open-labeled, multi-centric, randomised, comparative trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To evaluate the efficacy and tolerability of aceclofenac injection as compared to diclofenac injection in subjects suffering from acute lumago.
Ethics approval(s)	Institutional Ethic Committee approval taken for the study.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Aceclofenac
Primary outcome measure(s)	1. Assessment of overall response to study drugs. 2. Assessment of overall response of subjects to the drug.
Key secondary outcome measure(s)	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
Completion date	10/08/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	300
Key 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)
Key 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)
Date of first enrolment	02/05/2006
Date of final enrolment	10/08/2006

A-4, MIG

Madhya Pradesh
452001
India

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan