Osteoarthritis, KneePhase 2NCT00530452
Phase II Study of CG100649 for Primary Osteoarthritis in Male Subjects
A Phase 2 study testing CG100649 and Silicified microcrystalline cellulose + talc in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by CrystalGenomics, Inc. at 1 site in Germany.
Trial summary
The primary objective of this study is to evaluate the safety and efficacy of 3 loading and maintenance dose levels of CG100649 administered for 21 days in the treatment of osteoarthritis pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip
- What is being tested?
- CG100649 and Silicified microcrystalline cellulose + talc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2007to Sep 2008
- Phase
- Phase 2
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males, age 18-75 years old;
- BMI 19-35 kg/m2;
- Good health;
- Systolic BP 90-140 mmHg, diastolic BP 50-90 mmHg, resting HR 45-90 bpm without medication;
- Clinical chemistry profile within 2x normal range without medication;
- Urinalysis including urinary creatinine within 2x normal limits;
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- OA confirmed by radiographs obtained within the past 20 years and diagnosed according to ACR guidelines; subjects must qualify as ACR global functional status I, II, or III (excluding IV) and Kellgren-Lawrence grade 1, 2 or 3 (excluding grades 0 and 4);
- Subjects must have had chronic pain for ≥3 months from OA;
- Subjects must have been receiving stable oral doses of NSAIDs or COX-2 inhibitors at least 3 days per week for one month or longer;
- Subjects may take paracetamol ≤2g/day) for breakthrough pain;
- During the washout period, the average daily pain intensity (DPI) score must be between 4 and 8 on a 0-10 numerical rating scale for at least 3 days, and no greater than 9 for more than 1 day, in the last 5 days prior to randomization per Baseline pain diary;
- Subjects must be able to read, understand and follow the study instructions;
- Subjects and their sexual partners must agree to use double barrier contraception during the study period and for 2 months afterward.
Who cannot join
- Use of any analgesics except the study medication or paracetamol;
- Presence or history of peripheral edema within the past 5 years;
- History of congestive heart failure;
- Use of chemotherapy agents or history of cancer within five years prior to the screening visit;
- History of bacterial or viral infection requiring treatment with antibiotics, antivirals, or anti-retrovirals within 3 months of study;
- Use of drugs which are P450 3A4 inducers or inhibitors within the past 30 days;
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- Use of prescribed systemic or topical medications or any dietary aids or foods that are known to modulate drug metabolizing enzymes within 14 days of dose administration;
- Difficulty in swallowing oral medications;
- Subjects with gout, pseudogout, inflammatory arthritis, Paget's disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease;
- Subjects requiring knee or hip arthroplasty within 2 months of screening or anticipating any need for a surgical procedure on the index joint during the study;
- Subjects who have had surgery on the affected joint within one year prior to the study and subjects with a prosthesis at the index joint;
- Use of systemic corticosteroids within 2 months of screening, or intra-articular viscosupplementation within the past 6 months;
- History of seizure disorder;
- Use of antidepressants or anticonvulsants for any reason including for chronic pain within 2 months of screening;
- Serious psychosocial co-morbidities;
- Cognitive or psychiatric disorders, or daytime use of medications that could diminish compliance with study procedures, including maintenance of a daily pain and symptom diary and accurate dosing of study medication;
- Use of anticoagulants within 2 weeks of screening;
- Use of any medications that will affect pain perception;
- History of drug or alcohol abuse within one year prior to screening;
- Use of any other investigational drug within 1 month prior to randomization;
- Active gastrointestinal, renal, hepatic, or coagulant disorder within 1 month prior to randomization;
- Esophageal or gastroduodenal ulceration within 1 month prior to randomization;
- Hypersensitivity to NSAIDs, sulfonamides, COX-2 inhibitors, or carbonic anhydrase inhibitors;
- History of nasal polyps, bronchospasm or urticaria;
- Known allergy or hypersensitivity to sulfa drugs;
- Family history of significant cardiac disease;
- Occult blood in stool.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Orthopaedische Praxis
Bad Dürrheim, Baden-Wurttemberg, BW 78073
Klaus Lehnhardt, Dr. med.
About this study
Official title: Double-Blind, Placebo Controlled Phase II Repeat Dose Study of the Safety and Efficacy of Three Parallel Loading and Maintenance Dose Regimens of CG100649 Versus Placebo for the Treatment of Primary Osteoarthritis in Male Subjects
The primary objective of this study is to evaluate the safety and efficacy of 3 loading and maintenance dose levels of CG100649 administered for 21 days in the treatment of osteoarthritis pain.
Read the detailed description
This is a double-blind, placebo-controlled study. Subjects will discontinue current medications 5-14 days prior to randomization. Paracetamol (acetaminophen; ≤2 gm/day) may be used for breakthrough pain. Other NSAIDs, COX-2 inhibitors, opioids, and corticosteroids may not be used at any time during this study. Only subjects recording average DPI of 4 to 8 on a 0-10 numerical rating scale for at least 3 days, and no greater than 9 for more than 1 day, during the last 5 days of the washout period and meeting all other inclusion criteria will be randomized into the study.
Subjects meeting screening criteria will be randomized to receive 21 days dosing of an active dose of CG100649 or placebo.
Antiarthritic efficacy will be evaluated by changes in the Western Ontario and McMaster Universities (WOMAC) OA index completed on Day 0 (Baseline) and on Days 7, 14, 21, 28, and 35. DPI and functional interference (BPI scales) will be evaluated by subject diary during the screening period and on all study days through Day 35. Pain Relief will be evaluated on Days 7, 14, 21, 28, and 35.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- CG100649, Silicified microcrystalline cellulose + talc
- Keywords
- COX-2, carbonic anhydrase, osteoarthritis, anti-inflammatory, Cyclooxygenase Inhibitors
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG100649Drug
Dual-acting COX-2 inhibitor \& carbonic anhydrase inhibitor in gelatin capsules. Oral loading doses (2, 4, or 8 mg vs. placebo) followed by daily oral maintenance doses (0.3, 0.6, or 1.2 mg vs. placebo) for 20 days (total 21 days therapy).
Silicified microcrystalline cellulose + talcDrug
Gelatin capsules containing cellulose/talc matched for weight and color to experimental medication. Placebo administered orally 1x/day.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 2.0 mg (loading dose, Day 0) followed by 0.3 mg/day (Days 1-20) Receives: Drug: CG100649 |
| B | Experimental | 4.0 mg (loading dose, Day 0) followed by 0.6 mg/day (Days 1-20) Receives: Drug: CG100649 |
| C | Experimental | 8.0 mg (loading dose, Day 0) followed by 1.2 mg/day (Days 1-20) Receives: Drug: CG100649 |
| D | Placebo comparator | Placebo (identical number of capsules to active drug groups) (Days 0-20) Receives: Drug: Silicified microcrystalline cellulose + talc |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the change in the sum of the WOMAC OA index at Day 21 vs. Baseline (Day 0). The primary analysis will be via repeated measures using mixed effects ANOVA with baseline and subject as random variables.
Measured: 21 days
Secondary outcomes (1)
Change in av. Daily Pain Intensity (DPI) during last 7 days & entire 21 days); • Change in worst DPI (last 7 days; entire 21 days); • Change in WOMAC OA index on Days 7, 14, 28, and 35 vs. baseline; • Subject's Global Assessment • Safety
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionSep 2008 (estimated)
- Study completionSep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CrystalGenomics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Investigators
- William K Schmidt, PhD, Study director, CrystalGenomics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530452
- Sponsor's protocol ID
- CG100649-2-01
- Other IDs
- EudraCT number: 2007-001197-93
- Status last verified
- Jun 2008
- First submitted
- 13 Sep 2007
- Last updated
- 13 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo Controlled Phase II Repeat Dose Study of the Safety and Efficacy of Three Parallel Loading and Maintenance Dose Regimens of CG100649 Versus Placebo for the Treatment of Primary Osteoarthritis in Male Subjects
- ClinicalTrials.gov ID
- NCT00530452
- Acronym / sponsor ID
- CG100649-2-01
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- COX-2, carbonic anhydrase, osteoarthritis, anti-inflammatory, Cyclooxygenase Inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- CrystalGenomics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Oct 2007
- Primary completion
- Sep 2008 (estimated)
- Study completion
- Sep 2008 (estimated)
- First posted
- 17 Sep 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.
The primary objective of this study is to evaluate the safety and efficacy of 3 loading and maintenance dose levels of CG100649 administered for 21 days in the treatment of osteoarthritis pain.
Detailed description
This is a double-blind, placebo-controlled study. Subjects will discontinue current medications 5-14 days prior to randomization. Paracetamol (acetaminophen; ≤2 gm/day) may be used for breakthrough pain. Other NSAIDs, COX-2 inhibitors, opioids, and corticosteroids may not be used at any time during this study. Only subjects recording average DPI of 4 to 8 on a 0-10 numerical rating scale for at least 3 days, and no greater than 9 for more than 1 day, during the last 5 days of the washout period and meeting all other inclusion criteria will be randomized into the study.
Subjects meeting screening criteria will be randomized to receive 21 days dosing of an active dose of CG100649 or placebo.
Antiarthritic efficacy will be evaluated by changes in the Western Ontario and McMaster Universities (WOMAC) OA index completed on Day 0 (Baseline) and on Days 7, 14, 21, 28, and 35. DPI and functional interference (BPI scales) will be evaluated by subject diary during the screening period and on all study days through Day 35. Pain Relief will be evaluated on Days 7, 14, 21, 28, and 35.
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: CG1006492.0 mg (loading dose, Day 0) followed by 0.3 mg/day (Days 1-20) |
| B | Experimental | Drug: CG1006494.0 mg (loading dose, Day 0) followed by 0.6 mg/day (Days 1-20) |
| C | Experimental | Drug: CG1006498.0 mg (loading dose, Day 0) followed by 1.2 mg/day (Days 1-20) |
| D | Placebo comparator | Drug: Silicified microcrystalline cellulose + talcPlacebo (identical number of capsules to active drug groups) (Days 0-20) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males, age 18-75 years old;
- BMI 19-35 kg/m2;
- Good health;
- Systolic BP 90-140 mmHg, diastolic BP 50-90 mmHg, resting HR 45-90 bpm without medication;
- Clinical chemistry profile within 2x normal range without medication;
Key exclusion criteria (27 listed)
- Use of any analgesics except the study medication or paracetamol;
- Presence or history of peripheral edema within the past 5 years;
- History of congestive heart failure;
- Use of chemotherapy agents or history of cancer within five years prior to the screening visit;
- History of bacterial or viral infection requiring treatment with antibiotics, antivirals, or anti-retrovirals within 3 months of study;
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 |
|---|---|---|
| CG100649Dual-acting COX-2 inhibitor \& carbonic anhydrase inhibitor in gelatin capsules. Oral loading doses (2, 4, or 8 mg vs. placebo) followed by daily oral maintenance doses (0.3, 0.6, or 1.2 mg vs. placebo) for 20 days (total 21 days therapy). | Drug | A, B, C |
| Silicified microcrystalline cellulose + talcGelatin capsules containing cellulose/talc matched for weight and color to experimental medication. Placebo administered orally 1x/day. | Drug | D |
Primary outcome
The primary endpoint will be the change in the sum of the WOMAC OA index at Day 21 vs. Baseline (Day 0). The primary analysis will be via repeated measures using mixed effects ANOVA with baseline and subject as random variables.
Time frame: 21 days
1 secondary outcome
Change in av. Daily Pain Intensity (DPI) during last 7 days & entire 21 days); • Change in worst DPI (last 7 days; entire 21 days); • Change in WOMAC OA index on Days 7, 14, 28, and 35 vs. baseline; • Subject's Global Assessment • Safety
Time frame: 35 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2008.
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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.
William K Schmidt, PhD study director
CrystalGenomics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CG100649 and Silicified microcrystalline cellulose + talc in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by CrystalGenomics, Inc. at 1 site in Germany.
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 13 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 13 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefania Di Credico (+39 02 95794.1, stefania.decredico@quintiles.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint will be the change in the sum of the WOMAC OA index at Day 21 vs. Baseline (Day 0). The primary analysis will be via repeated measures using mixed effects ANOVA with baseline and subject as random variables. (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2008.