NCT00943098 is a Phase 3 clinical trial of Diclofenac HPBCD s.c. 75mg/ml in Dental Pain, sponsored by IBSA Institut Biochimique SA.

Who is sponsoring NCT00943098?

NCT00943098 is sponsored by IBSA Institut Biochimique SA.

What drugs are being tested in NCT00943098?

Interventions in NCT00943098: Diclofenac HPBCD s.c. 75mg/ml, Voltarol 75mg/3ml i.m..

What condition does NCT00943098 study?

NCT00943098 studies Dental Pain.

Is NCT00943098 still recruiting?

NCT00943098 is currently completed. Last updated 17 December 2012.

Are results published for NCT00943098?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2012-12-17 · How we verify

NCT00943098

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy and Safety of a Single s.c. Diclofenac HPBCD 75mg/1ml Injection as Compared to a Single i.m. Voltarol® 75mg/3ml, in the Treatment of Acute Moderate-to-severe Post-surgical Pain Following Dental Surgery (Impacted 3rd Molar Removal).

Completed Phase 3 Results posted Last updated 17 December 2012

What this trial tests

Phase 3 trial testing Diclofenac HPBCD s.c. 75mg/ml in Dental Pain in 142 participants. Completed in 1 May 2010.

Timeline

1 September 2009

Primary endpoint
1 March 2010

1 May 2010

Quick facts

Lead sponsor	IBSA Institut Biochimique SA
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	142
Start date	1 September 2009
Primary completion	1 March 2010
Estimated completion	1 May 2010
Sites	3 locations across United Kingdom

Drugs / interventions tested

Diclofenac HPBCD s.c. 75mg/ml — full drug profile →
Voltarol 75mg/3ml i.m. — full drug profile →

Conditions studied

Dental Pain — all drugs for Dental Pain →

Sponsor

IBSA Institut Biochimique SA — full company profile →

Who can join

Adults 18 to 65, any sex, with Dental Pain. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Pain Intensity Difference (PID)
Time frame: 1.5 hours
Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assessed by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).

Sponsor's own description

The present study is aimed at demonstrating the therapeutic equivalence of diclofenac HPBCD 75mg/1ml s.c. with the marketed reference product, Voltarol® 75mg/3ml i.m. in the treatment of acute moderate-to-severe pain after dental impaction surgery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Dental Pain

Currently open trials in the same condition.

NCT07239505 — A Randomized Controlled Trial Evaluating Whether Pre-operative Trinase Reduces Post-operative Pain in Patients With Symp · NA · recruiting
NCT06948162 — Exploration of the Utility of Dental-dedicated MRI for Dentistry · recruiting
NCT05351099 — Dental Block for Pain Relief in ED Dental Pain Patients · recruiting

Other IBSA Institut Biochimique SA trials

Trials by the same sponsor.

NCT06659692 — Pharmacokinetics of FSH and hCG Following Multiple Dose of Gonadotropins-IBSA. · Phase 1 · completed
NCT06781957 — Pharmacokinetics of FSH and hCG After a Single Subcutaneous Injection of Gonadotropins-IBSA · Phase 1 · completed
NCT05490680 — A New Sildenafil Oral Film in Patients With Erectile Dysfunction · Phase 3 · completed
NCT04549116 — Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer. · Phase 3 · active not recruiting
NCT05228184 — Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH) · Phase 4 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00943098 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by IBSA Institut Biochimique SA
Last refreshed: 17 December 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00943098.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing