NCT00942448 is a Phase 3 clinical trial of Diclofenac HPBCD in Dental Pain, sponsored by IBSA Institut Biochimique SA.

Who is sponsoring NCT00942448?

NCT00942448 is sponsored by IBSA Institut Biochimique SA.

What drugs are being tested in NCT00942448?

Interventions in NCT00942448: Diclofenac HPBCD, Diclofenac HPBCD, Diclofenac HPBCD, Placebo s.c..

What condition does NCT00942448 study?

NCT00942448 studies Dental Pain.

Is NCT00942448 still recruiting?

NCT00942448 is currently completed. Last updated 17 December 2012.

Are results published for NCT00942448?

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

NCT00942448

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

Efficacy and Safety Study of Diclofenac HPBCD 25, 50 mg/ml Administered as Single s.c. Dose, in the Treatment of Acute Moderate-to-severe Post-surgical Pain From Dental Surgery (Impacted 3rd Molar Extraction)

Completed Phase 3 Results posted Last updated 17 December 2012

What this trial tests

Phase 3 trial testing Diclofenac HPBCD in Dental Pain in 306 participants. Completed in 1 April 2010.

Timeline

1 September 2009

Primary endpoint
1 January 2010

1 April 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	306
Start date	1 September 2009
Primary completion	1 January 2010
Estimated completion	1 April 2010
Sites	6 locations across Poland, United Kingdom

Drugs / interventions tested

Diclofenac HPBCD — full drug profile →
Diclofenac HPBCD — full drug profile →
Diclofenac HPBCD — full drug profile →
Placebo s.c.

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) on a 0-100 VAS
Time frame: at 1.5 hours after treatment administration
Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned 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 proposed to evaluate the efficacy and safety of single doses of Diclofenac HPBCD subcutaneous (s.c.) (25 mg/1 ml and 50 mg/1 ml) 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 NCT00942448 (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/NCT00942448.

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