Pain, PostoperativePhase 3NCT00448110
Efficacy and Safety of IV Diclofenac (DIC075V) for Pain After Abdominal or Pelvic Surgery
A Phase 3 study testing Intravenous Diclofenac (DIC075V) and Intravenous Ketorolac in people with Pain, Postoperative, run by Javelin Pharmaceuticals at 14 sites in United States.
Trial summary
This study will compare repeated intermittent IV dosing of diclofenac in patients with moderate to severe post-surgical pain from abdominal or pelvic surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Intravenous Diclofenac (DIC075V) and Intravenous Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 331 participants
- Where
- 14 sitesUnited States
- Study dates
- May 2006to Nov 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled within two weeks of the screening visit to undergo abdominal or pelvic surgery
- Moderate to severe pain within 6 hours following completion of the required surgery.
Who cannot join
- Surgical procedure involves a subcostal incision.
- Chronic disease or recent cardiovascular events.
- Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.
- Additional Inclusion/Exclusion Criteria May Apply
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Clinical Research Center
Austin, Texas, 78705
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
Clinical Research Services
Bismarck, North Dakota, 58501
Visions Clinical Research
Boynton Beach, Florida, 33437
Duke University Medical Center
Durham, North Carolina, 27710
Eliza Coffee Memorial Hospital
Florence, Alabama, 35630
Glendale Adventist Medical Center
Glendale, California, 91206
Memorial Hermann Healthcare System - Memorial City Hospital
Houston, Texas, 77024
Saddleback Memorial Medical Center
Laguna Hills, California, 92653
Teton Research / Parkview Surgical
Little Rock, Arkansas, 72205
Drug Research and Analysis Corp.
Montgomery, Alabama, 36106
Jean Brown Research
Salt Lake City, Utah, 84124
Clinical Research Center
San Marcos, Texas, 78666
Helen Keller Hospital
Sheffield, Alabama, 35660
About this study
Official title: Randomized, Double-Blind, Active- and Placebo-Controlled Study of the Efficacy and Safety of Repeated Dosing of DIC075V Relative To Parenteral Ketorolac and Placebo in Patients With Acute Post-Op Pain After Abdominal or Pelvic Surgery
This study will compare repeated intermittent IV dosing of diclofenac in patients with moderate to severe post-surgical pain from abdominal or pelvic surgery.
Read the detailed description
The primary objective is to evaluate the efficacy and safety of two dosage levels of parenteral diclofenac in providing pain relief as compared to placebo or Ketorolac tromethamine.
- Conditions
- Pain, Postoperative
- Being tested
- Intravenous Diclofenac (DIC075V), Intravenous Ketorolac, placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Diclofenac (DIC075V)Drug
Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels
Intravenous KetorolacDrug
Intravenous Ketorolac
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | intravenous diclofenac dosage level 1 Receives: Drug: Intravenous Diclofenac (DIC075V) |
| B | Experimental | intravenous diclofenac dosage level 2 Receives: Drug: Intravenous Diclofenac (DIC075V) |
| C | Active comparator | intravenous ketorolac Receives: Drug: Intravenous Ketorolac |
| D | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of the pain intensity differences (SPID) over the 0-48 hour time interval.
Measured: 0-48 hours
Secondary outcomes (2)
SPID over the 0-24 hour interval
Measured: 0-24 hours
Other measures of pain relief
Measured: Multiple
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2007 (estimated)
- Study startMay 2006
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Javelin Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Javelin Pharmaceuticals, Study director, Javelin Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448110
- Sponsor's protocol ID
- DFC-004
- Status last verified
- May 2009
- First submitted
- 13 Mar 2007
- Last updated
- 22 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Chelly JE, Lacouture PG, Reyes CRD. Safety of Injectable HPbetaCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials. Drugs Aging. 2018 Mar;35(3):249-259. doi: 10.1007/s40266-018-0529-3.
PubMed 29492863Gan TJ, Daniels SE, Singla N, Hamilton DA, Carr DB. A novel injectable formulation of diclofenac compared with intravenous ketorolac or placebo for acute moderate-to-severe pain after abdominal or pelvic surgery: a multicenter, double-blind, randomized, multiple-dose study. Anesth Analg. 2012 Nov;115(5):1212-20. doi: 10.1213/ANE.0b013e3182691bf9. Epub 2012 Aug 10.
PubMed 22886837
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Active- and Placebo-Controlled Study of the Efficacy and Safety of Repeated Dosing of DIC075V Relative To Parenteral Ketorolac and Placebo in Patients With Acute Post-Op Pain After Abdominal or Pelvic Surgery
- ClinicalTrials.gov ID
- NCT00448110
- Acronym / sponsor ID
- DFC-004
- Conditions
- Pain, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Javelin PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 15 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare repeated intermittent IV dosing of diclofenac in patients with moderate to severe post-surgical pain from abdominal or pelvic surgery.
Detailed description
The primary objective is to evaluate the efficacy and safety of two dosage levels of parenteral diclofenac in providing pain relief as compared to placebo or Ketorolac tromethamine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Intravenous Diclofenac (DIC075V)intravenous diclofenac dosage level 1 |
| B | Experimental | Drug: Intravenous Diclofenac (DIC075V)intravenous diclofenac dosage level 2 |
| C | Active comparator | Drug: Intravenous Ketorolacintravenous ketorolac |
| D | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled within two weeks of the screening visit to undergo abdominal or pelvic surgery
- Moderate to severe pain within 6 hours following completion of the required surgery.
Key exclusion criteria (4 listed)
- Surgical procedure involves a subcostal incision.
- Chronic disease or recent cardiovascular events.
- Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.
- Additional Inclusion/Exclusion Criteria May Apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous Diclofenac (DIC075V)Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels | Drug | A, B |
| Intravenous KetorolacIntravenous Ketorolac | Drug | C |
| placeboplacebo | Drug | D |
Primary outcome
Sum of the pain intensity differences (SPID) over the 0-48 hour time interval.
Time frame: 0-48 hours
2 secondary outcomes
SPID over the 0-24 hour interval
Time frame: 0-24 hours
Other measures of pain relief
Time frame: Multiple
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2009.
- Derived from this study: PubMed 29492863Chelly JE, Lacouture PG, Reyes CRD. Safety of Injectable HPbetaCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials. Drugs Aging. 2018 Mar;35(3):249-259. doi: 10.1007/s40266-018-0529-3.
- Derived from this study: PubMed 22886837Gan TJ, Daniels SE, Singla N, Hamilton DA, Carr DB. A novel injectable formulation of diclofenac compared with intravenous ketorolac or placebo for acute moderate-to-severe pain after abdominal or pelvic surgery: a multicenter, double-blind, randomized, multiple-dose study. Anesth Analg. 2012 Nov;115(5):1212-20. doi: 10.1213/ANE.0b013e3182691bf9. Epub 2012 Aug 10.
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javelin Pharmaceuticals study director
Javelin Pharmaceuticals
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous Diclofenac (DIC075V) and Intravenous Ketorolac in people with Pain, Postoperative, run by Javelin Pharmaceuticals at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of the pain intensity differences (SPID) over the 0-48 hour time interval. (time frame: 0-48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00448110, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2009; AzTrials last refreshed its copy on 8 Nov 2026.