NCT01706588 (DP4) is a Phase 2 clinical trial of Diclofenac sodium in Pain, sponsored by IBSA Institut Biochimique SA.

Who is sponsoring NCT01706588?

NCT01706588 is sponsored by IBSA Institut Biochimique SA.

What drugs are being tested in NCT01706588?

Interventions in NCT01706588: Diclofenac sodium.

Is NCT01706588 still recruiting?

NCT01706588 is currently completed. Last updated 28 August 2014.

Are results published for NCT01706588?

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

Last reviewed 2014-08-28 · How we verify

NCT01706588: DP4

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

Preliminary Evaluation of the Efficacy and Local Tolerability of Injectable Diclofenac at 5, 12.5, 25 and 50 mg/mL, Administered Locally Prior to Surgery for the Prevention of Post-operative Pain After Third Molar Surgery

Completed Phase 2 Results posted Last updated 28 August 2014

What this trial tests

Phase 2 trial testing Diclofenac sodium in Pain in 75 participants. Completed in 1 May 2013.

Timeline

1 January 2013

Primary endpoint
1 May 2013

1 May 2013

Quick facts

Lead sponsor	IBSA Institut Biochimique SA
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	75
Start date	1 January 2013
Primary completion	1 May 2013
Estimated completion	1 May 2013
Sites	1 location across United Kingdom

Drugs / interventions tested

Diclofenac sodium (Diclofenac Sodium) — full drug profile →

Conditions studied

Pain — all drugs for Pain →

Sponsor

IBSA Institut Biochimique SA — full company profile →

Who can join

Adults 18 to 65, any sex, with 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.

Area Under the Curve (AUC) of the Pain Scores.
Time frame: Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery
Pain will be scored by the patient at the end of surgery (time 0) and at 15-minute intervals after surgery for a total of 6 hours on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).

Sponsor's own description

This is a prospective, randomised, double-blind, placebo-controlled, parallel group study in approximately 75 patients undergoing surgical removal of an impacted lower third molar.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Submucosal Diclofenac for Acute Postoperative Pain in Third Molar Surgery: A Randomized, Controlled Clinical Trial.
Gorecki P, Rainsford KD, Taneja P, Bulsara Y, et al · · 2018 · cited 12× · PMID 29202646 · DOI 10.1177/0022034517744207

Verify or expand the search:

Other trials of Diclofenac sodium

Trials testing the same drug.

NCT07565012 — Comparative Evaluation of Diclofenac Sodium and Ibuprofen for Post-Endodontic Pain Management · Phase 4 · completed
NCT07237620 — The Effect of Different Intracanal Medicaments on Periapical Lesion Healing · NA · recruiting
NCT06090500 — Effect of Submucosal Cryotherapy on Postoperative Endodontic Pain · NA · completed
NCT03221946 — A Comparative Evaluation of Diclofenac Sodium Transdermal Patch, Oral Diclofenac Sodium With Intramuscular Injections of · Phase 4 · completed
NCT02201238 — Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium · Phase 1 · completed

Other recruiting trials for Pain

Currently open trials in the same condition.

NCT07533409 — Tactile and Pain Sensory Thresholds and Hand Grip Strength · recruiting
NCT07294092 — Ketamine and Propofol NeuroImaging · EARLY_PHASE1 · recruiting
NCT07290205 — Remimazolam NeuroImaging · EARLY_PHASE1 · recruiting
NCT07487610 — Relationship Between Neuropathic Pain and Geriatric Assessment Parameters in Patients Aged 80 Years and Older · recruiting
NCT07454993 — The Effect of Music During Colonoscopy · NA · 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 NCT01706588 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
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: 28 August 2014

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/NCT01706588.

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